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A pilot study of the effectiveness of a serious game CliniPup® on perioperative anxiety and pain in children
Journal Pre-proof A pilot study of the effectiveness of a serious game CliniPup® on perioperative anxiety and pain in children
Lucas E. Matthyssens, Amber Vanhulle, Lara Seldenslach, Geert Vander Stichele, Marc Coppens, Eline Van Hoecke PII:
S0022-3468(19)30766-3
DOI:
https://doi.org/10.1016/j.jpedsurg.2019.10.031
Reference:
YJPSU 59458
To appear in:
Journal of Pediatric Surgery
Received date:
19 October 2019
Accepted date:
26 October 2019
Please cite this article as: L.E. Matthyssens, A. Vanhulle, L. Seldenslach, et al., A pilot study of the effectiveness of a serious game CliniPup® on perioperative anxiety and pain in children, Journal of Pediatric Surgery(2019), https://doi.org/10.1016/ j.jpedsurg.2019.10.031
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© 2019 Published by Elsevier.
Journal Pre-proof
A PILOT STUDY OF THE EFFECTIVENESS OF A SERIOUS GAME CLINIPUP® ON PERIOPERATIVE ANXIETY AND PAIN IN CHILDREN Authors: Lucas E. MATTHYSSENS MD FEBPS1, Amber VANHULLE2*, Lara SELDENSLACH2*, Geert VANDER STICHELE MSc PharmD3,
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Marc COPPENS MD PhD4,
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Eline VAN HOECKE MP PhD5
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*: Joint Second Authors
Author Affiliations: 1
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Paediatric Surgeon, Department of Paediatric Surgery / Gastrointestinal Surgery, Princess Elisabeth Children’s Hospital, Ghent University Hospital, Ghent University, C. Heymanslaan 10, B-9000 Ghent, Belgium 2 Medical Student, Faculty of Medicine and Health Sciences, Ghent University, Campus UZ Ghent, C. Heymanslaan 10, B-9000 Ghent, Belgium 3 Co-creator of Clinipup®, Founder and CEO of Mindbytes BVBA, Schoondreef 7, Merksplas, Belgium 4 Anaesthesiologist, Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent University, C. Heymanslaan 10, B-9000 Ghent, Belgium 5 Paediatric Psychologist, Department of Paediatrics, Paediatric Psychology, Princess Elisabeth Children’s Hospital, Ghent University Hospital, Ghent University, C. Heymanslaan 10, B-9000 Ghent, Belgium
Corresponding Author: Dr Lucas E. MATTHYSSENS, MD FEBPS Department of Paediatric Surgery/Gastrointestinal Surgery – 2K12C Ghent University Hospital 10, C. Heymanslaan B-9000 Ghent Belgium E-mail: [email protected] Telephone: +3293325562 Fax: +3293321503
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1. INTRODUCTION Perioperative anxiety and pain in children are common and positively correlated: approximately 60% of children experience important anxiety on the day of their operation and one third of children reports significant pain up to one week postoperatively [1-6]. Children with higher anxiety levels also experience significantly more pain postoperatively [1-3, 6-12]. Parents play an important role in assessing their child's anxiety and pain and communicating this to health professionals [11, 13]. However, many parents often do not know how to deal with the fear and pain of their child. It has
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also been shown that parental anxiety is also strongly related to the child’s perioperative anxiety and
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pain, and reducing anxiety in parents may therefore decrease preoperative anxiety in children [2, 3, 9, 10, 12, 14, 15]. Non-pharmacological interventions are increasingly popular as a safe and non-
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invasive alternative to the pharmacological treatment of anxiety and pain [11, 13, 16]. Distraction and relaxation exercises, but also providing accurate information adapted to the age and intelligence
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level of a patient (e.g. by preoperative preparation programs), may lead to a reduction in anxiety [3, 6, 11, 14] because this gives a feeling of control, in children and in parents [2, 3, 5, 10, 11, 14, 15,
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17].
Ambulatory or day-care surgery for children is increasing the last decades in many countries such as
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the UK, the USA and also in Belgium, counting over 25,000 ambulatory surgical procedures in children aged 6-10 years each year. [18] Although it has many advantages and is more cost-effective,
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studies have shown that the contact moments between patient and caregivers during day-care surgery are limited, with fewer time to provide information to the patient and family [3, 11, 14]. In addition, managing perioperative pain and anxiety is particularly challenging in children, because the experience of pain and anxiety differs from adults, children have limited skills to communicate pain and anxiety, and they have a limited understanding of the surgery purpose and process because of limited cognitive development [18]. The use of serious games (i.e. digital games used for purposes other than purely entertainment) is a novel and promising approach to prepare, educate, and/or distract children, that may result in health outcome benefits such as reduction in perioperative anxiety [19, 20]. Serious games may offer an environment in which attractive learning tasks are presented in a way that addresses the difficulties of children who will undergo surgery. Many games and apps market themselves as tools or interventions to address health conditions, yet they provide little explanation on their development and often there is a lack of evidence-based research. There is an increasing recognition of the importance of creating evidence-based games
Journal Pre-proof that are purposefully designed using expertise, knowledge, and validated, quality data. CliniPup® is a serious game, developed by Mindbytes BVBA using the SERES Framework ([18], to prepare children between 5 and 11 years old for a day-care operation, telling the story of a little dog that takes you with him through the day of his operation. The serious game is based on four major principles: (1) customized information about the course of an operation, (2) modeling and learning coping strategies, (3) expressing feelings and bodily sensations and (4) an E-learning module for parents (providing information about practical perioperative aspects, as well as coping strategies for the parent and advice for anxiety and pain management in the child). Preliminary results of a limited pilot study indicated CliniPup® to be a potentially effective and attractive adjunct therapy to existing
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interventions aimed at reducing preoperative anxiety in children undergoing ambulatory surgery. Due to a small sample size and methodological limitations, further research of CliniPup® was
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recommended [20].
Online digital games also function as a distraction for most children which can also be helpful to
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reduce perioperative anxiety. To investigate the additional effect of the educational aspects in the
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serious game CliniPup®, the study design included a comparison group, exposing the children in this group to a newly developed so-called ‘empty game’ (catching flying monsters) with comparable
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visual aids but without any educational elements.
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This pilot study examined the effects of the serious game CliniPup® on the perioperative anxiety and pain in children undergoing day-care surgery and also on parental state anxiety before surgery. We
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hypothesized that children in the intervention group would report less anxiety and pain when compared to children and parents in both the comparison and control groups at several time points.
2. METHODS 2.1. Participants
Children treated in the departments of Paediatric general surgery, dentistry, otorhinolaryngology (ENT) or urology of the University Hospital Ghent were invited to participate in this trial. Inclusion criteria were: (1) age from 5 to 11 years old and (2) being scheduled for ambulatory surgery. Exclusion criteria were (1) children with a mental disability and (2) parents that did not speak and understand the Dutch language. Eligible parents and children were informed by their treating clinician about the study. If the parent(s) and child agreed, they received detailed written and oral information about the study by the researchers.
Journal Pre-proof After written and signed parental informed consent, participants were randomly assigned to one of three groups, by block-randomization.
2.2. Study design This study was a prospective, randomized controlled trial (RCT) conducted at the University Hospital of Ghent (UZG) in Ghent, Belgium, from October 2017 to May 2018 and approved by the UZG Medical Ethics Committee (EC/2017/0824 and EC/2017/0825). Study participants were randomly assigned to an intervention group (A) (CliniPup®), to a comparison group (B) (“Empty Game”) or to a control Group (C) (Standard of Care), by the use of a predefined computerized block randomization
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technique (blocks of each 21 patients). The treating surgeons, anesthetists and caregivers were blinded for the assignation of the patients.
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The parents of the children in Group A received by electronic mail a link to the CliniPup® serious game, including a link to the e-learning module for parents and a link to digital scoring tools. The
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parents of the children in Group B received by electronic mail a link to a digital computer game and a
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link to the digital scoring tools. The parents and children in this group were blinded that this computer game was an “Empty game”, lacking the educational elements contained in the CliniPup®
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game, in order to investigate the superiority of the educational aspects of CliniPup® to mere distraction. The parents of the patients in Group C received only a link to the digital scoring tools by
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electronic mail. These patients and their parents had received oral information on the planned surgical intervention at the preoperative outpatient clinic (which was, at that moment, the standard
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of care at our hospital).
Anxiety, pain and behavior were evaluated at six different timepoints (Figure 1): T0: baseline, at home, one week preoperatively, before the intervention; T1: at home, one week preoperatively, after playing the CliniPup® game (Group A) or the Empty game (Group B); T2: at hospital admission, preoperatively; T3: at hospital, postoperatively, before discharge; T4: at home, one week postoperatively; T5: at home, one month postoperatively. The anxiety and pain of the child were assessed by the child itself and by the parent(s) at T0-T4 by the use of a digital Visual Analogue Scale (VAS) - scoring tool (anxiety: VASa and VASa-on-child and pain: VASp and VASp-on-child) [21, 22]. Parental anxiety was measured at hospital admission (T2) by using the State-Trait Anxiety Inventory (STAI) [23] (see below, 2.3.2). Behaviour of the child was evaluated one month postoperatively (T5) by using the PostHospitalization Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) [24] (see below, 2.3.3).
Journal Pre-proof Figure 1 shows a visual presentation of the study design, the different groups and time points for measurements in relation to the surgery.
2.3. Study outcome measures
2.3.1. Preoperative anxiety and pain Anxiety and pain were assessed by using a Visual Analogue Scale (VAS), a validated psychometric scale with good sensitivity and validity for children aged seven years and older [21]. The use of VAS for pain requires selecting a point on a line representing the dimension of pain intensity. Recently
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the psychometric properties of the VAS for anxiety were evaluated for children undergoing day-care
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surgery [22].
In this trial, a link to a digital VAS-scoring tool was sent by electronic mail to the parents, to be used
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to report anxiety (VASa) and pain (VASp), by the child itself (self-report) and by the parents of the
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2.3.2. Parental preoperative anxiety
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child (“VASa-on-child” and “VASp-on-child”), on predefined moments in time.
To evaluate the perioperative anxiety of the parent, the State-Trait Anxiety Inventory (STAI) was
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used, a widely used validated questionnaire, with 2 subscales: the Trait Anxiety Scale and the State Anxiety Scale. In this trial, only State Anxiety was used to evaluate the current state of anxiety. The
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subscale comprises 20 questions with a Likert scale from 1 to 4 (1 = not at all, 4 = very many). The STAI score can be calculated by adding all scores (range 20 tot 80) [23]. A link to a digital STAI questionnaire was sent by electronic mail to the parent(s), to be filled out by the parent(s) on T2.
2.3.3. Postoperative behaviour
Possible behavioural changes in the child after day-care surgery were measured by the validated Post Hospitalization Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS)[24]. This parentreported tool assesses new-onset maladaptive behaviors in children after day-care hospitalization. For each item (n=11), parents are asked to compare their child’s behaviour before hospitalization to their current behaviour on a Likert scale using five response options: much less than before (1), less than before (2), same as before (3), more than before (4), and much more than before (5). A link to the PHBQ-AS was sent by electronic mail to the parents, to be filled out on T5. 2.4. Statistical analysis
Journal Pre-proof Due to a lack of data and reference points from a previous preliminary pilot study, no formal power analysis was performed [20]. All data were analyzed using IBM SPSS Statistics® version 24. The significance level was set at = 0.05. A difference of p < 0.05 was considered statistically significant. A linear mixed model was fitted for VAS anxiety and VAS pain. The fixed part of the model included study group (3 categories), timepoint (5 categories), type of surgery (4 categories), a two-way interaction between study group and timepoint, and a two-way interaction between timepoint and type of surgery. An unstructured covariance pattern was specified to allow for correlations between VAS measurements at different timepoints within the same child. The correlation between VAS reported by the child and “VAS-on-child” reported by the parent was
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analyzed based upon a Linear Mixed Model with random effects and without fixed factors, by calculation of the Standard Error of the Mean (SEM) and the Interclass Correlation Coefficient (ICC).
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Calculation of SEM (indicating congruence) and ICC (indicating reliance) were based upon previously described formulas [25, 26], with ICC values above 0.7 indicating good reliance, and SEM values
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being proportional to potential bias by standard errors.
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Due to the limited sample size, non-parametric tests were used for the statistical analysis. The Kruskal-Wallis test was used to analyze differences in age between the three groups, to analyze the
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impact of type of operation (“surgery type”) within groups, and differences in parental anxiety (STAI) and postoperative behavioural changes (PHBQ-AS) between the three groups. The impact of
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differences in gender between the groups was analyzed with the Chi-square test. The Spearman correlation coefficient was used to analyze the correlation between anxiety and pain, and the
3.
RESULTS
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correlation between parental anxiety (STAI) and anxiety of the child (VASa).
3.1. Description of patient population
In total 167 children and their parent(s) were contacted to participate in this study. 69 were excluded before participation for different reasons: no parental informed consent (n=9), matching the exclusion criteria (n=17), “other reasons” (n=25) and reasons not stated (n=18). After written and signed parental informed consent, 98 patients were assigned to one of the groups by blockrandomization. Due to various reasons, 26 children did not complete the entire study (“dropouts”): 17 in Group A, 5 in Group B and 4 in Group C. Seventy-two children completed the entire study: 25 in Group A, 22 in Group B and 25 in Group C, [Figure 2]. The demographic and clinical characteristics of the patients in the three groups are presented in Table 1. The groups were similar with respect to age and gender of the child, suggesting
Journal Pre-proof a high level of homogeneity. Analysis of the difference in distribution of the type of operation (“surgery type”) among the groups (see Table 1) showed borderline significance (p = 0.050) as Group A included more urological patients, while more dental operations were performed in the patients of Groups B and C. Further analysis, focusing on a regression coefficient (especially when comparing the VASa of Groups A and Group C on T4), showed a relative change of 14%. Therefore, according to Twisk [27] “surgery type” was taken into account as a possible confounder (change > 10%) and analyses of the data were corrected for “surgery type”.
3.2. Peri-operative anxiety
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At baseline (T0), the estimated mean anxiety score (VASa) was 2.8 units in Group A, 2.5 units in Group B and 4.5 units in Group C, see Table 2. Patients in Group A and B showed a lower anxiety
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score than Group C. The estimated mean VASa was 1.71 units lower in Group A compared to Group C (b = -1.71; 95% CI from -3.57 to 0.16; P = 0.07). Group B had an estimated mean VASa that was
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1.98 units lower than Group C (b = -1.98; 95% CI from -3.89 to -0.07; P = 0.04), which was statistically
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significant. The difference in anxiety between Group A and B was not significant. After correction for
baseline (T0), [Table 2].
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“surgery type”, the differences between the study groups were not statistically significant at
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Comparing the effect of playing the CliniPup® and “Empty game” at (T1), the estimated mean anxiety score (VASa) was lower in Group A (1.9 units) versus Group B (2.7 units), see Table 2. Comparing the VASa of Groups A and B with the baseline score of Group C, the estimated mean VASa after playing
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the CliniPup® game was 2.6 units lower compared to Group C (b = -2.60, 95% CI from -4.31 to -0.89, p = 0.003). A statistically significant difference was also observed for Group B; with anxiety levels being 1.8 units lower than in Group C (b = -1.80, 95% CI from -3.55 to -0.04, p = 0.045). The VASa in Group A was lower than in Group B, but this difference was not statistically significant (p =0.362). After correction for “surgery type”, Group A continued to show a significantly lower VASa compared to Group C (b = -1.91, 95% CI from -3.76 to -0.05, p = 0.044), [Table 2 and Figure 3]. The difference between Groups B and C became non-significant (b = -1.69, 95% CI from -3.45 to 0.07, P = 0.06), as was the difference between Groups A and B (P = 0.81). Within the different groups, the mean anxiety score (VASa) in Group A significantly decreased after playing the Clinipup® game, from 2.8 units at baseline (T0) to 1.9 units at (T1) (b = -0.92, 95% CI from -1.52 to - 0.32, P = 0.003), [Table 2 and Figure 3]. In the contrary, in Group B, a slight increase in anxiety was noted after playing the ‘Empty game’, with VASa from 2.5 units on T0 to 2.7 units after
Journal Pre-proof playing (T1), although this trend was not statistically significant (b = 0.16, 95% CI from -0.48 to 0.80, P = 0.62). At hospital admission (T2), Groups A and B showed lower levels of anxiety than Group C, but this difference was not statistically significant. Before discharge (T3) there was no difference in anxiety between the three groups. One week after the operation (T4), there was less anxiety in Groups A and B compared to Group C, but this was not statistically significant, [Table 2].
3.3. Peri-operative pain At baseline (T0), the estimated mean pain score (VASp) was 0.5 units in Group A, 1.4 units in Group B
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and 1.6 units in Group C. The VASp was lower in Group A compared to Group C, but did not reach statistically significance (b = -1.01; 95% CI from -2.08 to -0.06; P = 0.06). No statistically significant
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difference was found between Groups B and C, nor between Groups A and B. When corrected for “surgery type”, no statistically significant difference was found between the three groups, see Figure
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4.
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After playing the respective games (T1), the estimated mean pain score (VASp) was 0.4 units in Group A and 1.1 units in Group B. In both groups, this reduction in VASp was not statistically
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significant. Compared to Group C, the pain score of Group A was significantly lower, with a difference in estimated mean VASp of 1.12 units (b = -1.12; 95% CI from -2.10 to -0.14, P = 0.03).
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After correction for “surgery type”, this difference became non-significant (b = -0.95; 95% CI from 2.05 to -0.15, P = 0.09), [ figure 4]. No statistically significant difference in VASp was found between
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the other groups, with or without correction for “surgery type”. At hospital admission (T2), Group A showed less pain than Group B, but this difference was not statistically significant. Before discharge (T3) and one week after the operation (T4), the differences in estimated mean VASp between the three groups were not statistically significant, with or without correction for “surgery type”.
3.4. Correlation between anxiety and pain Anxiety and pain were significantly correlated in this study, except at the baseline measurement (T0) and immediately after surgery (T3), [Table 3].
3.5. Correlation between VAS and VAS-on-child When comparing the “VASa-on-child” (as reported by the parent) with the VASa (reported by the child) for measuring anxiety, the ICC values at T1, T2 and T3 were below 0.7 with SEM values between 1.08 and 1.88 (Table 4). For pain, the ICC values at T1 and T2 were also below 0.7, with all
Journal Pre-proof SEM values above 1.04 (Table 8). This implies that for anxiety and pain, the use of the “VAS-on-child” in this study was not a reliable predictor for the VAS reported by the child – thus that “VAS-on-child” was not to be used if the VAS (of the child itself) were missing.
3.6. Correlation between VAS anxiety (child) and STAI (parental anxiety) No statistically significant linear association (P = 0.57) was found between the anxiety reported by the child (VASa) and the anxiety of the parent (STAI) as measured preoperatively in the hospital on (T2). This means that in this study the anxiety of the child was not influenced by the anxiety of the
3.7. Difference in parental anxiety (STAI) according to group
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parent and vice versa.
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There was no statistically significant difference (P = 0.45, n=34) in parental anxiety as measured by the STAI-score between the groups. Parents of children in Group A did not report a lower anxiety
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score (STAI) on T2, despite their exposure to the e-learning module, accompanying the CliniPup®
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game.
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3.8. Difference in postoperative behavioral changes after one month (PHBQ-AS) between the groups Analysis of the PHBQ-AS-scores by the Kruskal-Wallis test did not show a significant difference (P =
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0.78) between the groups.
DISCUSSION
As ambulatory or day-care surgery is increasing in the last decades and as time is limited for healthcare professionals to provide accurate information to patients and their family, alternative time- and cost-effective methods have to be investigated [18]. Preparing children for surgery by providing information and learning coping skills are recognized as important ways to minimize negative consequences on children [29]. The use of a serious game such as CliniPup® is a relatively novel and promising approach to prepare children for surgery, that may result in health outcome benefits such as reduction in perioperative anxiety [18, 20, 28]. After playing the CliniPup® serious game before planned ambulatory surgery, children were found to have a statistically significant reduction in anxiety, compared to their own anxiety score at baseline, i.e. before playing the serious game (T0). They also had a significant lower anxiety score compared to
Journal Pre-proof children that played no game but only received oral information given at the preoperative outpatient clinic (Group C). The study design of this pilot randomized controlled trial with blinded randomization into three groups included a “comparison group” with an “Empty game” with comparable visual aids but without any educational elements. This made it possible to also investigate the reduction in anxiety by distraction and to compare this to the additional educational elements from the CliniPup® serious game. We deliberately opted to use a newly created ‘empty game’ (instead of well-known commercially available entertainment game) not to have too large differences in the prior familiarity of the game. After playing the digital “Empty game”, children in Group B were also found to have
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lower anxiety scores than children that did not play a digital game (Group C). However, after playing the “Empty game”, there was an increase in anxiety compared to the own anxiety score at baseline
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(T0). Distraction may thus lead to lower anxiety levels, but the educational elements from the CliniPup® serious game seemed to provide additional/more profound anxiety reduction. At almost all
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other timepoints, the level of anxiety in the ‘gaming groups’ (Groups A & B) was lower than in Group
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C, but this difference was only statistically significant on T0 and T1, see Figure 3. The results for pain were almost similar to the results for anxiety. Preoperatively, after playing the
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CliniPup® serious game (T1), the children in Group A reported lower pain scores than the children in the other two groups. This difference was only statistically significant when compared to Group C at
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timepoint T1 and after correction for surgery type the statistical significance was no longer present. As for anxiety, the differences in VAS scores for pain between the groups at other timepoints were
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not statistically significant.
There may be various explanations for these findings. First, the measuring instrument used in the study might not be sensitive enough to detect a relevant decrease in anxiety and pain scores. Previous studies using more ‘objective’ physiological measurements, such as heart rate and blood pressure, showed however conflicting results [11, 14, 29]. Furthermore, other possible predictors of perioperative anxiety and pain may not have been taken into account. Extra analysis of the data showed that the type of operation (“surgery type”) might be a possible confounder and therefore, correction for “surgery type” was applied in the statistical analysis. Additional psychological factors, such as the child’s temperament and potential previous medical experiences (of the child or parent) were also not taken into account in the study design.
This study confirmed the positive correlation between anxiety and pain in children. This was statistically significant at most timepoints, except at baseline (T0) and postoperatively (T3).
Journal Pre-proof In contrast to previous data in the literature, this study did not find a significant correlation between the child’s anxiety (VASa) and parental anxiety, as measured by the STAI: the anxiety of the child and the anxiety of the parent did not seem to influence each other. In addition, this study did not find a significant correlation between the VAS (self-reported by the child) and the “VAS-on-child” (as reported by the parent): the “VAS-on-child” score by the parent was in this study not a reliable predictor for how the child scored his or her anxiety or pain. Parents were given the option to provide personal feedback on the game and the study. This resulted in many positive reactions: many parents felt that their child did benefit from playing the CliniPup® serious game and found the information useful, to better prepare themselves and their
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child for the operation. On the other hand, several parents stated that they thought their child was too young or too old for the game. A few parents refused participation “because their child did not
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experience any fear towards the surgery” and some were concerned that participation would induce anxiety in their child. Statistical analysis of the results of this study showed however significantly
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lower anxiety levels in the children after playing the CliniPup® game. Linear regression analysis within
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Group A did also not reveal significant differences in anxiety and pain according to age.
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An important limitation of this study was the small number of participants and the relatively high number of dropouts, especially in Group A. Analysis showed that this was mainly due to technical
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problems with the online game platform (‘bugs’) and non-compliance among parents. The high number of timepoints and measuring moments may partially explain the non-compliance of certain
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parents. As this was a pilot-study, the evaluation of the study design and of the technical features and game-related elements (including technical stability of the game and the online game platform) were part of the study. In addition, both games were at the time not available on mobile devices, nor could they be played in the hospital on the day of surgery. There was also individual variation between the participants in the time span between playing the game and the day of operation. This temporal variation might have had an effect on anxiety scoring as well: children may indicate higher anxiety scores as the day of surgery approaches, and the effect of the CliniPup® game might diminish with time passing. Finally, the type of operation (“surgery type”) was initially not taken into account in the randomization, but statistical analysis showed this variable to be a possible confounder. Therefore, all analyses were corrected for “surgery type”. Future studies should therefore include the “surgery type” as a separate stratum. Another recommendation is to perform the baseline measurement of anxiety and pain before the participants are even assigned to a study group via randomization, to further eliminate potential bias. A power analysis based upon the results of this study, will help to
Journal Pre-proof calculate the adequate sample size needed for further studies. Providing the game(s) on mobile devices will potentially increase the impact of the games, facilitating the exposure to the games, also in the hours immediately prior to the operation. In conclusion, this pilot trial showed that children that played the CliniPup® serious game one week before ambulatory surgery had a statistically significant reduction in preoperative anxiety, but not in reducing postoperative pain. Playing the CliniPup® serious game led to lower anxiety levels than playing an “Empty game” (distraction only). Given the promising results of this pilot study, it is recommended to further investigate the effectiveness of the CliniPup® serious game on anxiety and
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pain in children undergoing different types of surgery.
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DISCLOSURES
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The authors declare no conflict of interest for none of the Ghent University affiliated authors (LM,
other rewards from Mindbytes BVBA.
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LS, AV, MC or EVH): none of the Ghent University affiliated authors did ever receive payments or
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Author GV is founder and CEO of Mindbytes BVBA.
ACKNOWLEDGEMENTS
The authors wish to thank Charlotte Vander Stichele, Niki Ver Donk and their colleagues at Mindbytes BVBA for providing and co-creating the serious game CliniPup®, for creating and providing the “Empty game” and for their kind collaboration in studying the effectiveness of the CliniPup® serious game.
The authors also wish to thank Dr. Stefanie De Buyser, biomedical statistician at the Faculty of Medicine and Health Sciences at Ghent University, for her expert assistance in the statistical analysis of the study results.
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8. He HG, Zhu L, Chan SW, Liam JL, Li HC, Ko SS, et al. Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a
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randomized controlled trial. J Adv Nurs. 2015;71[5]:1032-43. 9. Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006;118[2]:651-8.
10. Perrott C, Lee CA, Griffiths S, Sury MRJ. Perioperative experiences of anesthesia reported by children and parents. Paediatr Anaesth. 2018;28[2]:149-56. 11. Shaheen A, Nassar O, Khalaf I, et al. The effectiveness of age-appropriate pre-operative information session on the anxiety level of school-age children undergoing elective surgery in Jordan. Int J Nurs Pract. 2018;24[3]:e12634. 12. Walther-Larsen S, Aagaard GB, Friis SM, Petersen T, Moller-Sonnergaard J, Romsing J. Structured intervention for management of pain following day surgery in children. Paediatr Anaesth. 2016;26[2]:151-7. 13. Merkel SI, Danaher JA, Williams J. Pain Management in the Post-Operative Pediatric Urologic Patient. Urol Nurs. 2015;35[2]:75-81, 100.
Journal Pre-proof 14. Fernandes S, Arriaga P, Esteves F. Using an Educational Multimedia Application to Prepare Children for Outpatient Surgeries. Health Commun. 2015;30[12]:1190-200. 15. Li HC, Lopez V, Lee TL. Psychoeducational preparation of children for surgery: the importance of parental involvement. Patient Educ Couns. 2007;65[1]:34-41. 16. Al-Yateem N, Brenner M, Shorrab AA, Docherty C. Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: a randomized controlled non-inferiority trial. Child Care Health Dev. 2016;42[4]:572-81. 17. Li HC, Lopez V. Effectiveness and appropriateness of therapeutic play intervention in preparing children for surgery: a randomized controlled trial study. J Spec Pediatr Nurs.
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2008;13[2]:63-73. 18. Verschueren S, van Aalst J, Bangels AM, et al. Development of CliniPup, a serious game
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aimed at reducing perioperative anxiety and pain in children: mixed methods study. JMIR Serious Games. 2019;7[2]:e12429, doi:10.2196/12429.
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19. Bul K CM, Kato PM, Van der oord S, et al. Behavioral Outcome Effects of Serious Gaming as Attention-Deficit/Hyperactivity Disorder: A
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Randomized Controlled Trial. J Med Internet Res. 2016; 18[2]: e26, doi:10.2196/jmir.5173
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20. Buffel C, van Aalst J, Bangels AM, et al. A Web-based Serious Game for Health to Reduce Perioperative Anxiety and Pain in Children (CliniPup): Pilot Randomized Controlled Trial.
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JMIR Serious Games. 2019; 7 [2]:e12431. doi:10.2196/12431. 21. Von Baeyer CL Children’s self-reports of pain intensity: Scale selection, limitations and
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interpretation. Pain Res Manage 2006; 11(3): 157-162. 22. Berghmans JM, Poley MJ, van der Ende J, Weber F, Van de Velde M, Adriaenssens P, Himpe D, Verhulst FC, Utens E. A Visual Analog Scale to assess anxiety in children during anesthesia induction (VAS-I): Results supporting its validity in a sample of day care surgery patients. Paediatr Anaesth. 2017 Sep;27(9):955-961. doi: 10.1111/pan.13206. 23. Jenkins BN, Kain ZN, Kaplan SK, Stevenson RS, Mayes LC, Guadarrama J & Michelle A. Fortier MA. Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery. Pediatric Anesthesia 25 (2015) 738–745. 24. Spielberger, C. State-Trait Anxiety Inventory For Adults: Manual, Menlo Park: Mind Garden; 1983. 25. Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. Journal of Chiropractic Medicine. 2016;15:155–63.
Journal Pre-proof 26. Vet HCWd, Terwee CB, Knol DL, Bouter LM. When to use agreement versus reliability measures. J Clin Epidemiol. 2006:1033–9. 27. Twisk JWR. Inleiding in de toegepaste biostatistiek: Reed Business; 2014. 28. Fleming TM, Bavin L, Stasiak K, Hermansson-Webb E, Merry SN, Cheek C, et al. Serious Games and gamification for mental health: current status and promising directions. Front Psychiatry. 2016;7:215. 29. Fernandes SC, Arriaga P, Esteves F. Providing preoperative information for children undergoing surgery: a randomized study testing different types of educational material to
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reduce children's preoperative worries. Health Educ Res. 2014;29; 1058-76.
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LEGENDS TO THE TABLES AND FIGURES Table 1: Baseline study participants characteristics Table 2: Linear Mixed Model analysis for VAS anxiety (VASa) This table is an overview of the differences in estimated mean VASa between the different groups at different study timepoints. Significant P-values are indicated in bold. Group A: Intervention group (Clinipup®), Group B: Comparison group (Empty game); Group C:
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Control group (no game)
Table 3: Correlation between VAS scores for anxiety (VASa) and VAS scores for pain (VASp) on
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different study timepoints
Significant P-values are indicated in bold
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Figure 1: Study design flowchart
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This table shows the Spearman correlation coefficient with corresponding P-value at each timepoint.
Abbreviations: VAS = Visual Analogue Scale; STAI = State-Trait Anxiety Inventory; PHBQ-AS = Post
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Hospitalization Behaviour Questionnaire for Ambulatory Surgery Figure 2: Patient recruitment and participation flow diagram
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Figure 3: Estimated mean VAS scores for anxiety (VASa) at different study timepoints Statistically significant value (A versus C) is indicated with horizontal bar and P-value
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Error bars represent the 95% confidence intervals around the estimated means Group A: Intervention group (Clinipup®), Group B: Comparison group (Empty game), Group C: Control group (no game)
T0: baseline, at home; T1: after playing, at home; T2: at hospital admission; T3: postoperatively, before discharge; T4: one week postoperatively, at home. Figure 4: Estimated mean VAS scores for pain (VASp) at different study timepoints Error bars represent the 95% confidence intervals around the estimated means Group A: Intervention group (Clinipup®), Group B: Comparison group (Empty game), Group C: Control group [no game] T0: baseline, at home; T1: after playing, at home, T2: at hospital admission; T3: postoperatively, before discharge; T4: one week postoperatively, at home.
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Table 1: Baseline study participants characteristics Total sample
Intervention
Comparison
Control
(n=72)
Group A
Group B
Group C
(n=25)
(n=22)
(n=25)
7.32 (2.0)
7.36 (1.8)
7.64 (2.3)
7.00 (1.8)
Male, n (%)
49 (68.1)
17 (68.0)
16 (73.0)
16 (64.0)
Female, n (%)
23 (31.9)
8 (32.0)
6 (27.0)
9 (36.0)
Dentistry
31 (43.1)
4 (12.9)
Urology
20 (27.8)
11(55.0)
Ear-Nose-Throat
15 (20.8)
General surgery
6 (8.3)
Age in years, mean (SD)
Surgery type, n (%)
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Child’s gender
16 (51.6)
4 (20.0)
5 (25.0)
7 (46.7)
5 (33.3)
3 (20.0)
3 (50.0)
2 (33.3)
1 (16.7)
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11 (35.5)
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B compared to C Baseline, at home [T0] After playing, at home [T1] Hospital admission [T2] Before discharge [T3] 1 week postoperatively [T4]
-
4.5
2.4
-
4.1
1.3
-
0.8
1.1
-
2.0
A
B
C
2.8
2.5
-
1.9
2.7
-
2.4
2.5
-
1.3
1.2
-
1.1
1.2
A
B
-
2.5
C
-2.60 -1.66 0.51
-3.57; 0.16 -4.31; 0.89 -3.90; 0.58 -0.91; 1.93
4.5
-
2.7
4.5
-
2.5
4.1
-
1.2
0.8
-
1.2
2.0
0.07 0.003 0.14 0.47
-0.85
-2.32; 0.63
0.25
95% CI
Pvalue
0.27 -0.80 -0.14 0.13
-1.63; 2.17 -2.56; 0.95 -2.47; 2.20 -1.41; 1.67
-0.07
-1.68; 1.55
95% CI
-1.98 -1.80 -1.53 0.38
-0.78 ®
-3.89; 0.07 -3.55; 0.04 -3.60; 0.54 -1.00; 1.77 -2.41; 0.84
C
3.0
-
4.1
2.2
-
4.1
2.0
-
3.6
2.3
-
1.3
1.1
-
1.8
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1.9
-1.71
B
A
B
C
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4.5
A
2.3
-
2.2
2.4
-
2.0
2.2
-
2.3
1.8
-
1.1
1.2
-
0.78
3.0
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Baseline, at home [T0] After playing, at home [T1] Hospital admission [T2] Before discharge [T3] 1 week postoperatively [T4]
-
Pvalue
95% CI
0.36 0.91
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A compared to B
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Baseline, at home [T0] After playing, at home [T1] Hospital admission [T2] Before discharge [T3] 1 week postoperatively [T4]
Estimated Mean VASa corrected
UNCORRECTED
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A compared to C
Estimated Mean VASa uncorrected A B C
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ANXIETY
0.87 0.93
Pvalue 0.04 0.04 0.14 0.58 0.34
A
B
C
-
2.3
4.1
-
2.4
4.1
-
2.2
3.6
-
1.8
1.3
-
1.2
1.8
CORRECTED -1.17 -1.91 -1.60 1.01
95% CI -3.22; 0.88 -3.76; 0.05 -4.03; 0.83 -0.34; 2.37
Pvalue 0.26 0.04 0.19 0.14
-0.72
-2.39; 0.95
0.39
95% CI
Pvalue
0.68 -0.22 -0.15 0.58
-1.34; 2.70 -2.07; 1.63 -2.65; 2.35 -0.86; 2.02
0.50 0.81 0.90 0.42
-0.07
-1.82; 1.69
0.94
95% CI
Pvalue
-1.85 -1.69 -1.45 0.44 -0.65
-3.80; 0.09 -3.45; 0.07 -3.57; 0.68 -0.80; 1.68 -2.32; 1.01
0.06 0.06 0.18 0.48 0.44
Note: A = Intervention Group (CliniPup ); B = Comparison Group (Empty game); C = Control Group (no game)
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Table 3: Correlation between VAS anxiety [VASa] and VAS pain [VASp] on different timepoints P-value
Baseline [T0]
0.197
0.19
After playing [T1]
0.255
0.04
Hospital admission [T2]
0.340
0.04
Before discharge [T3]
0.299
0.06
1 week postoperatively [T4]
0.512
0.00
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Spearman correlation coefficient
Figure 1
Figure 2
Figure 3
Figure 4
Lucas E. Matthyssens, Amber Vanhulle, Lara Seldenslach, Geert Vander Stichele, Marc Coppens, Eline Van Hoecke PII:
S0022-3468(19)30766-3
DOI:
https://doi.org/10.1016/j.jpedsurg.2019.10.031
Reference:
YJPSU 59458
To appear in:
Journal of Pediatric Surgery
Received date:
19 October 2019
Accepted date:
26 October 2019
Please cite this article as: L.E. Matthyssens, A. Vanhulle, L. Seldenslach, et al., A pilot study of the effectiveness of a serious game CliniPup® on perioperative anxiety and pain in children, Journal of Pediatric Surgery(2019), https://doi.org/10.1016/ j.jpedsurg.2019.10.031
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
© 2019 Published by Elsevier.
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A PILOT STUDY OF THE EFFECTIVENESS OF A SERIOUS GAME CLINIPUP® ON PERIOPERATIVE ANXIETY AND PAIN IN CHILDREN Authors: Lucas E. MATTHYSSENS MD FEBPS1, Amber VANHULLE2*, Lara SELDENSLACH2*, Geert VANDER STICHELE MSc PharmD3,
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Marc COPPENS MD PhD4,
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Eline VAN HOECKE MP PhD5
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*: Joint Second Authors
Author Affiliations: 1
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Paediatric Surgeon, Department of Paediatric Surgery / Gastrointestinal Surgery, Princess Elisabeth Children’s Hospital, Ghent University Hospital, Ghent University, C. Heymanslaan 10, B-9000 Ghent, Belgium 2 Medical Student, Faculty of Medicine and Health Sciences, Ghent University, Campus UZ Ghent, C. Heymanslaan 10, B-9000 Ghent, Belgium 3 Co-creator of Clinipup®, Founder and CEO of Mindbytes BVBA, Schoondreef 7, Merksplas, Belgium 4 Anaesthesiologist, Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital, Ghent University, C. Heymanslaan 10, B-9000 Ghent, Belgium 5 Paediatric Psychologist, Department of Paediatrics, Paediatric Psychology, Princess Elisabeth Children’s Hospital, Ghent University Hospital, Ghent University, C. Heymanslaan 10, B-9000 Ghent, Belgium
Corresponding Author: Dr Lucas E. MATTHYSSENS, MD FEBPS Department of Paediatric Surgery/Gastrointestinal Surgery – 2K12C Ghent University Hospital 10, C. Heymanslaan B-9000 Ghent Belgium E-mail: [email protected] Telephone: +3293325562 Fax: +3293321503
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1. INTRODUCTION Perioperative anxiety and pain in children are common and positively correlated: approximately 60% of children experience important anxiety on the day of their operation and one third of children reports significant pain up to one week postoperatively [1-6]. Children with higher anxiety levels also experience significantly more pain postoperatively [1-3, 6-12]. Parents play an important role in assessing their child's anxiety and pain and communicating this to health professionals [11, 13]. However, many parents often do not know how to deal with the fear and pain of their child. It has
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also been shown that parental anxiety is also strongly related to the child’s perioperative anxiety and
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pain, and reducing anxiety in parents may therefore decrease preoperative anxiety in children [2, 3, 9, 10, 12, 14, 15]. Non-pharmacological interventions are increasingly popular as a safe and non-
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invasive alternative to the pharmacological treatment of anxiety and pain [11, 13, 16]. Distraction and relaxation exercises, but also providing accurate information adapted to the age and intelligence
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level of a patient (e.g. by preoperative preparation programs), may lead to a reduction in anxiety [3, 6, 11, 14] because this gives a feeling of control, in children and in parents [2, 3, 5, 10, 11, 14, 15,
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17].
Ambulatory or day-care surgery for children is increasing the last decades in many countries such as
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the UK, the USA and also in Belgium, counting over 25,000 ambulatory surgical procedures in children aged 6-10 years each year. [18] Although it has many advantages and is more cost-effective,
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studies have shown that the contact moments between patient and caregivers during day-care surgery are limited, with fewer time to provide information to the patient and family [3, 11, 14]. In addition, managing perioperative pain and anxiety is particularly challenging in children, because the experience of pain and anxiety differs from adults, children have limited skills to communicate pain and anxiety, and they have a limited understanding of the surgery purpose and process because of limited cognitive development [18]. The use of serious games (i.e. digital games used for purposes other than purely entertainment) is a novel and promising approach to prepare, educate, and/or distract children, that may result in health outcome benefits such as reduction in perioperative anxiety [19, 20]. Serious games may offer an environment in which attractive learning tasks are presented in a way that addresses the difficulties of children who will undergo surgery. Many games and apps market themselves as tools or interventions to address health conditions, yet they provide little explanation on their development and often there is a lack of evidence-based research. There is an increasing recognition of the importance of creating evidence-based games
Journal Pre-proof that are purposefully designed using expertise, knowledge, and validated, quality data. CliniPup® is a serious game, developed by Mindbytes BVBA using the SERES Framework ([18], to prepare children between 5 and 11 years old for a day-care operation, telling the story of a little dog that takes you with him through the day of his operation. The serious game is based on four major principles: (1) customized information about the course of an operation, (2) modeling and learning coping strategies, (3) expressing feelings and bodily sensations and (4) an E-learning module for parents (providing information about practical perioperative aspects, as well as coping strategies for the parent and advice for anxiety and pain management in the child). Preliminary results of a limited pilot study indicated CliniPup® to be a potentially effective and attractive adjunct therapy to existing
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interventions aimed at reducing preoperative anxiety in children undergoing ambulatory surgery. Due to a small sample size and methodological limitations, further research of CliniPup® was
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recommended [20].
Online digital games also function as a distraction for most children which can also be helpful to
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reduce perioperative anxiety. To investigate the additional effect of the educational aspects in the
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serious game CliniPup®, the study design included a comparison group, exposing the children in this group to a newly developed so-called ‘empty game’ (catching flying monsters) with comparable
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visual aids but without any educational elements.
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This pilot study examined the effects of the serious game CliniPup® on the perioperative anxiety and pain in children undergoing day-care surgery and also on parental state anxiety before surgery. We
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hypothesized that children in the intervention group would report less anxiety and pain when compared to children and parents in both the comparison and control groups at several time points.
2. METHODS 2.1. Participants
Children treated in the departments of Paediatric general surgery, dentistry, otorhinolaryngology (ENT) or urology of the University Hospital Ghent were invited to participate in this trial. Inclusion criteria were: (1) age from 5 to 11 years old and (2) being scheduled for ambulatory surgery. Exclusion criteria were (1) children with a mental disability and (2) parents that did not speak and understand the Dutch language. Eligible parents and children were informed by their treating clinician about the study. If the parent(s) and child agreed, they received detailed written and oral information about the study by the researchers.
Journal Pre-proof After written and signed parental informed consent, participants were randomly assigned to one of three groups, by block-randomization.
2.2. Study design This study was a prospective, randomized controlled trial (RCT) conducted at the University Hospital of Ghent (UZG) in Ghent, Belgium, from October 2017 to May 2018 and approved by the UZG Medical Ethics Committee (EC/2017/0824 and EC/2017/0825). Study participants were randomly assigned to an intervention group (A) (CliniPup®), to a comparison group (B) (“Empty Game”) or to a control Group (C) (Standard of Care), by the use of a predefined computerized block randomization
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technique (blocks of each 21 patients). The treating surgeons, anesthetists and caregivers were blinded for the assignation of the patients.
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The parents of the children in Group A received by electronic mail a link to the CliniPup® serious game, including a link to the e-learning module for parents and a link to digital scoring tools. The
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parents of the children in Group B received by electronic mail a link to a digital computer game and a
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link to the digital scoring tools. The parents and children in this group were blinded that this computer game was an “Empty game”, lacking the educational elements contained in the CliniPup®
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game, in order to investigate the superiority of the educational aspects of CliniPup® to mere distraction. The parents of the patients in Group C received only a link to the digital scoring tools by
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electronic mail. These patients and their parents had received oral information on the planned surgical intervention at the preoperative outpatient clinic (which was, at that moment, the standard
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of care at our hospital).
Anxiety, pain and behavior were evaluated at six different timepoints (Figure 1): T0: baseline, at home, one week preoperatively, before the intervention; T1: at home, one week preoperatively, after playing the CliniPup® game (Group A) or the Empty game (Group B); T2: at hospital admission, preoperatively; T3: at hospital, postoperatively, before discharge; T4: at home, one week postoperatively; T5: at home, one month postoperatively. The anxiety and pain of the child were assessed by the child itself and by the parent(s) at T0-T4 by the use of a digital Visual Analogue Scale (VAS) - scoring tool (anxiety: VASa and VASa-on-child and pain: VASp and VASp-on-child) [21, 22]. Parental anxiety was measured at hospital admission (T2) by using the State-Trait Anxiety Inventory (STAI) [23] (see below, 2.3.2). Behaviour of the child was evaluated one month postoperatively (T5) by using the PostHospitalization Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) [24] (see below, 2.3.3).
Journal Pre-proof Figure 1 shows a visual presentation of the study design, the different groups and time points for measurements in relation to the surgery.
2.3. Study outcome measures
2.3.1. Preoperative anxiety and pain Anxiety and pain were assessed by using a Visual Analogue Scale (VAS), a validated psychometric scale with good sensitivity and validity for children aged seven years and older [21]. The use of VAS for pain requires selecting a point on a line representing the dimension of pain intensity. Recently
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the psychometric properties of the VAS for anxiety were evaluated for children undergoing day-care
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surgery [22].
In this trial, a link to a digital VAS-scoring tool was sent by electronic mail to the parents, to be used
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to report anxiety (VASa) and pain (VASp), by the child itself (self-report) and by the parents of the
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2.3.2. Parental preoperative anxiety
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child (“VASa-on-child” and “VASp-on-child”), on predefined moments in time.
To evaluate the perioperative anxiety of the parent, the State-Trait Anxiety Inventory (STAI) was
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used, a widely used validated questionnaire, with 2 subscales: the Trait Anxiety Scale and the State Anxiety Scale. In this trial, only State Anxiety was used to evaluate the current state of anxiety. The
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subscale comprises 20 questions with a Likert scale from 1 to 4 (1 = not at all, 4 = very many). The STAI score can be calculated by adding all scores (range 20 tot 80) [23]. A link to a digital STAI questionnaire was sent by electronic mail to the parent(s), to be filled out by the parent(s) on T2.
2.3.3. Postoperative behaviour
Possible behavioural changes in the child after day-care surgery were measured by the validated Post Hospitalization Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS)[24]. This parentreported tool assesses new-onset maladaptive behaviors in children after day-care hospitalization. For each item (n=11), parents are asked to compare their child’s behaviour before hospitalization to their current behaviour on a Likert scale using five response options: much less than before (1), less than before (2), same as before (3), more than before (4), and much more than before (5). A link to the PHBQ-AS was sent by electronic mail to the parents, to be filled out on T5. 2.4. Statistical analysis
Journal Pre-proof Due to a lack of data and reference points from a previous preliminary pilot study, no formal power analysis was performed [20]. All data were analyzed using IBM SPSS Statistics® version 24. The significance level was set at = 0.05. A difference of p < 0.05 was considered statistically significant. A linear mixed model was fitted for VAS anxiety and VAS pain. The fixed part of the model included study group (3 categories), timepoint (5 categories), type of surgery (4 categories), a two-way interaction between study group and timepoint, and a two-way interaction between timepoint and type of surgery. An unstructured covariance pattern was specified to allow for correlations between VAS measurements at different timepoints within the same child. The correlation between VAS reported by the child and “VAS-on-child” reported by the parent was
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analyzed based upon a Linear Mixed Model with random effects and without fixed factors, by calculation of the Standard Error of the Mean (SEM) and the Interclass Correlation Coefficient (ICC).
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Calculation of SEM (indicating congruence) and ICC (indicating reliance) were based upon previously described formulas [25, 26], with ICC values above 0.7 indicating good reliance, and SEM values
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being proportional to potential bias by standard errors.
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Due to the limited sample size, non-parametric tests were used for the statistical analysis. The Kruskal-Wallis test was used to analyze differences in age between the three groups, to analyze the
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impact of type of operation (“surgery type”) within groups, and differences in parental anxiety (STAI) and postoperative behavioural changes (PHBQ-AS) between the three groups. The impact of
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differences in gender between the groups was analyzed with the Chi-square test. The Spearman correlation coefficient was used to analyze the correlation between anxiety and pain, and the
3.
RESULTS
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correlation between parental anxiety (STAI) and anxiety of the child (VASa).
3.1. Description of patient population
In total 167 children and their parent(s) were contacted to participate in this study. 69 were excluded before participation for different reasons: no parental informed consent (n=9), matching the exclusion criteria (n=17), “other reasons” (n=25) and reasons not stated (n=18). After written and signed parental informed consent, 98 patients were assigned to one of the groups by blockrandomization. Due to various reasons, 26 children did not complete the entire study (“dropouts”): 17 in Group A, 5 in Group B and 4 in Group C. Seventy-two children completed the entire study: 25 in Group A, 22 in Group B and 25 in Group C, [Figure 2]. The demographic and clinical characteristics of the patients in the three groups are presented in Table 1. The groups were similar with respect to age and gender of the child, suggesting
Journal Pre-proof a high level of homogeneity. Analysis of the difference in distribution of the type of operation (“surgery type”) among the groups (see Table 1) showed borderline significance (p = 0.050) as Group A included more urological patients, while more dental operations were performed in the patients of Groups B and C. Further analysis, focusing on a regression coefficient (especially when comparing the VASa of Groups A and Group C on T4), showed a relative change of 14%. Therefore, according to Twisk [27] “surgery type” was taken into account as a possible confounder (change > 10%) and analyses of the data were corrected for “surgery type”.
3.2. Peri-operative anxiety
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At baseline (T0), the estimated mean anxiety score (VASa) was 2.8 units in Group A, 2.5 units in Group B and 4.5 units in Group C, see Table 2. Patients in Group A and B showed a lower anxiety
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score than Group C. The estimated mean VASa was 1.71 units lower in Group A compared to Group C (b = -1.71; 95% CI from -3.57 to 0.16; P = 0.07). Group B had an estimated mean VASa that was
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1.98 units lower than Group C (b = -1.98; 95% CI from -3.89 to -0.07; P = 0.04), which was statistically
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significant. The difference in anxiety between Group A and B was not significant. After correction for
baseline (T0), [Table 2].
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“surgery type”, the differences between the study groups were not statistically significant at
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Comparing the effect of playing the CliniPup® and “Empty game” at (T1), the estimated mean anxiety score (VASa) was lower in Group A (1.9 units) versus Group B (2.7 units), see Table 2. Comparing the VASa of Groups A and B with the baseline score of Group C, the estimated mean VASa after playing
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the CliniPup® game was 2.6 units lower compared to Group C (b = -2.60, 95% CI from -4.31 to -0.89, p = 0.003). A statistically significant difference was also observed for Group B; with anxiety levels being 1.8 units lower than in Group C (b = -1.80, 95% CI from -3.55 to -0.04, p = 0.045). The VASa in Group A was lower than in Group B, but this difference was not statistically significant (p =0.362). After correction for “surgery type”, Group A continued to show a significantly lower VASa compared to Group C (b = -1.91, 95% CI from -3.76 to -0.05, p = 0.044), [Table 2 and Figure 3]. The difference between Groups B and C became non-significant (b = -1.69, 95% CI from -3.45 to 0.07, P = 0.06), as was the difference between Groups A and B (P = 0.81). Within the different groups, the mean anxiety score (VASa) in Group A significantly decreased after playing the Clinipup® game, from 2.8 units at baseline (T0) to 1.9 units at (T1) (b = -0.92, 95% CI from -1.52 to - 0.32, P = 0.003), [Table 2 and Figure 3]. In the contrary, in Group B, a slight increase in anxiety was noted after playing the ‘Empty game’, with VASa from 2.5 units on T0 to 2.7 units after
Journal Pre-proof playing (T1), although this trend was not statistically significant (b = 0.16, 95% CI from -0.48 to 0.80, P = 0.62). At hospital admission (T2), Groups A and B showed lower levels of anxiety than Group C, but this difference was not statistically significant. Before discharge (T3) there was no difference in anxiety between the three groups. One week after the operation (T4), there was less anxiety in Groups A and B compared to Group C, but this was not statistically significant, [Table 2].
3.3. Peri-operative pain At baseline (T0), the estimated mean pain score (VASp) was 0.5 units in Group A, 1.4 units in Group B
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and 1.6 units in Group C. The VASp was lower in Group A compared to Group C, but did not reach statistically significance (b = -1.01; 95% CI from -2.08 to -0.06; P = 0.06). No statistically significant
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difference was found between Groups B and C, nor between Groups A and B. When corrected for “surgery type”, no statistically significant difference was found between the three groups, see Figure
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4.
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After playing the respective games (T1), the estimated mean pain score (VASp) was 0.4 units in Group A and 1.1 units in Group B. In both groups, this reduction in VASp was not statistically
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significant. Compared to Group C, the pain score of Group A was significantly lower, with a difference in estimated mean VASp of 1.12 units (b = -1.12; 95% CI from -2.10 to -0.14, P = 0.03).
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After correction for “surgery type”, this difference became non-significant (b = -0.95; 95% CI from 2.05 to -0.15, P = 0.09), [ figure 4]. No statistically significant difference in VASp was found between
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the other groups, with or without correction for “surgery type”. At hospital admission (T2), Group A showed less pain than Group B, but this difference was not statistically significant. Before discharge (T3) and one week after the operation (T4), the differences in estimated mean VASp between the three groups were not statistically significant, with or without correction for “surgery type”.
3.4. Correlation between anxiety and pain Anxiety and pain were significantly correlated in this study, except at the baseline measurement (T0) and immediately after surgery (T3), [Table 3].
3.5. Correlation between VAS and VAS-on-child When comparing the “VASa-on-child” (as reported by the parent) with the VASa (reported by the child) for measuring anxiety, the ICC values at T1, T2 and T3 were below 0.7 with SEM values between 1.08 and 1.88 (Table 4). For pain, the ICC values at T1 and T2 were also below 0.7, with all
Journal Pre-proof SEM values above 1.04 (Table 8). This implies that for anxiety and pain, the use of the “VAS-on-child” in this study was not a reliable predictor for the VAS reported by the child – thus that “VAS-on-child” was not to be used if the VAS (of the child itself) were missing.
3.6. Correlation between VAS anxiety (child) and STAI (parental anxiety) No statistically significant linear association (P = 0.57) was found between the anxiety reported by the child (VASa) and the anxiety of the parent (STAI) as measured preoperatively in the hospital on (T2). This means that in this study the anxiety of the child was not influenced by the anxiety of the
3.7. Difference in parental anxiety (STAI) according to group
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parent and vice versa.
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There was no statistically significant difference (P = 0.45, n=34) in parental anxiety as measured by the STAI-score between the groups. Parents of children in Group A did not report a lower anxiety
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score (STAI) on T2, despite their exposure to the e-learning module, accompanying the CliniPup®
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game.
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3.8. Difference in postoperative behavioral changes after one month (PHBQ-AS) between the groups Analysis of the PHBQ-AS-scores by the Kruskal-Wallis test did not show a significant difference (P =
4.
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0.78) between the groups.
DISCUSSION
As ambulatory or day-care surgery is increasing in the last decades and as time is limited for healthcare professionals to provide accurate information to patients and their family, alternative time- and cost-effective methods have to be investigated [18]. Preparing children for surgery by providing information and learning coping skills are recognized as important ways to minimize negative consequences on children [29]. The use of a serious game such as CliniPup® is a relatively novel and promising approach to prepare children for surgery, that may result in health outcome benefits such as reduction in perioperative anxiety [18, 20, 28]. After playing the CliniPup® serious game before planned ambulatory surgery, children were found to have a statistically significant reduction in anxiety, compared to their own anxiety score at baseline, i.e. before playing the serious game (T0). They also had a significant lower anxiety score compared to
Journal Pre-proof children that played no game but only received oral information given at the preoperative outpatient clinic (Group C). The study design of this pilot randomized controlled trial with blinded randomization into three groups included a “comparison group” with an “Empty game” with comparable visual aids but without any educational elements. This made it possible to also investigate the reduction in anxiety by distraction and to compare this to the additional educational elements from the CliniPup® serious game. We deliberately opted to use a newly created ‘empty game’ (instead of well-known commercially available entertainment game) not to have too large differences in the prior familiarity of the game. After playing the digital “Empty game”, children in Group B were also found to have
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lower anxiety scores than children that did not play a digital game (Group C). However, after playing the “Empty game”, there was an increase in anxiety compared to the own anxiety score at baseline
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(T0). Distraction may thus lead to lower anxiety levels, but the educational elements from the CliniPup® serious game seemed to provide additional/more profound anxiety reduction. At almost all
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other timepoints, the level of anxiety in the ‘gaming groups’ (Groups A & B) was lower than in Group
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C, but this difference was only statistically significant on T0 and T1, see Figure 3. The results for pain were almost similar to the results for anxiety. Preoperatively, after playing the
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CliniPup® serious game (T1), the children in Group A reported lower pain scores than the children in the other two groups. This difference was only statistically significant when compared to Group C at
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timepoint T1 and after correction for surgery type the statistical significance was no longer present. As for anxiety, the differences in VAS scores for pain between the groups at other timepoints were
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not statistically significant.
There may be various explanations for these findings. First, the measuring instrument used in the study might not be sensitive enough to detect a relevant decrease in anxiety and pain scores. Previous studies using more ‘objective’ physiological measurements, such as heart rate and blood pressure, showed however conflicting results [11, 14, 29]. Furthermore, other possible predictors of perioperative anxiety and pain may not have been taken into account. Extra analysis of the data showed that the type of operation (“surgery type”) might be a possible confounder and therefore, correction for “surgery type” was applied in the statistical analysis. Additional psychological factors, such as the child’s temperament and potential previous medical experiences (of the child or parent) were also not taken into account in the study design.
This study confirmed the positive correlation between anxiety and pain in children. This was statistically significant at most timepoints, except at baseline (T0) and postoperatively (T3).
Journal Pre-proof In contrast to previous data in the literature, this study did not find a significant correlation between the child’s anxiety (VASa) and parental anxiety, as measured by the STAI: the anxiety of the child and the anxiety of the parent did not seem to influence each other. In addition, this study did not find a significant correlation between the VAS (self-reported by the child) and the “VAS-on-child” (as reported by the parent): the “VAS-on-child” score by the parent was in this study not a reliable predictor for how the child scored his or her anxiety or pain. Parents were given the option to provide personal feedback on the game and the study. This resulted in many positive reactions: many parents felt that their child did benefit from playing the CliniPup® serious game and found the information useful, to better prepare themselves and their
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child for the operation. On the other hand, several parents stated that they thought their child was too young or too old for the game. A few parents refused participation “because their child did not
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experience any fear towards the surgery” and some were concerned that participation would induce anxiety in their child. Statistical analysis of the results of this study showed however significantly
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lower anxiety levels in the children after playing the CliniPup® game. Linear regression analysis within
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Group A did also not reveal significant differences in anxiety and pain according to age.
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An important limitation of this study was the small number of participants and the relatively high number of dropouts, especially in Group A. Analysis showed that this was mainly due to technical
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problems with the online game platform (‘bugs’) and non-compliance among parents. The high number of timepoints and measuring moments may partially explain the non-compliance of certain
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parents. As this was a pilot-study, the evaluation of the study design and of the technical features and game-related elements (including technical stability of the game and the online game platform) were part of the study. In addition, both games were at the time not available on mobile devices, nor could they be played in the hospital on the day of surgery. There was also individual variation between the participants in the time span between playing the game and the day of operation. This temporal variation might have had an effect on anxiety scoring as well: children may indicate higher anxiety scores as the day of surgery approaches, and the effect of the CliniPup® game might diminish with time passing. Finally, the type of operation (“surgery type”) was initially not taken into account in the randomization, but statistical analysis showed this variable to be a possible confounder. Therefore, all analyses were corrected for “surgery type”. Future studies should therefore include the “surgery type” as a separate stratum. Another recommendation is to perform the baseline measurement of anxiety and pain before the participants are even assigned to a study group via randomization, to further eliminate potential bias. A power analysis based upon the results of this study, will help to
Journal Pre-proof calculate the adequate sample size needed for further studies. Providing the game(s) on mobile devices will potentially increase the impact of the games, facilitating the exposure to the games, also in the hours immediately prior to the operation. In conclusion, this pilot trial showed that children that played the CliniPup® serious game one week before ambulatory surgery had a statistically significant reduction in preoperative anxiety, but not in reducing postoperative pain. Playing the CliniPup® serious game led to lower anxiety levels than playing an “Empty game” (distraction only). Given the promising results of this pilot study, it is recommended to further investigate the effectiveness of the CliniPup® serious game on anxiety and
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pain in children undergoing different types of surgery.
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DISCLOSURES
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The authors declare no conflict of interest for none of the Ghent University affiliated authors (LM,
other rewards from Mindbytes BVBA.
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LS, AV, MC or EVH): none of the Ghent University affiliated authors did ever receive payments or
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Author GV is founder and CEO of Mindbytes BVBA.
ACKNOWLEDGEMENTS
The authors wish to thank Charlotte Vander Stichele, Niki Ver Donk and their colleagues at Mindbytes BVBA for providing and co-creating the serious game CliniPup®, for creating and providing the “Empty game” and for their kind collaboration in studying the effectiveness of the CliniPup® serious game.
The authors also wish to thank Dr. Stefanie De Buyser, biomedical statistician at the Faculty of Medicine and Health Sciences at Ghent University, for her expert assistance in the statistical analysis of the study results.
REFERENCES
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5. Perry JN, Hooper VD, Masiongale J. Reduction of preoperative anxiety in pediatric surgery patients using age-appropriate teaching interventions. J Perianesth Nurs. 2012;27[2]:69-81.
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6. Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and intervention strategies
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7. Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children. Paediatr
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8. He HG, Zhu L, Chan SW, Liam JL, Li HC, Ko SS, et al. Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a
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randomized controlled trial. J Adv Nurs. 2015;71[5]:1032-43. 9. Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006;118[2]:651-8.
10. Perrott C, Lee CA, Griffiths S, Sury MRJ. Perioperative experiences of anesthesia reported by children and parents. Paediatr Anaesth. 2018;28[2]:149-56. 11. Shaheen A, Nassar O, Khalaf I, et al. The effectiveness of age-appropriate pre-operative information session on the anxiety level of school-age children undergoing elective surgery in Jordan. Int J Nurs Pract. 2018;24[3]:e12634. 12. Walther-Larsen S, Aagaard GB, Friis SM, Petersen T, Moller-Sonnergaard J, Romsing J. Structured intervention for management of pain following day surgery in children. Paediatr Anaesth. 2016;26[2]:151-7. 13. Merkel SI, Danaher JA, Williams J. Pain Management in the Post-Operative Pediatric Urologic Patient. Urol Nurs. 2015;35[2]:75-81, 100.
Journal Pre-proof 14. Fernandes S, Arriaga P, Esteves F. Using an Educational Multimedia Application to Prepare Children for Outpatient Surgeries. Health Commun. 2015;30[12]:1190-200. 15. Li HC, Lopez V, Lee TL. Psychoeducational preparation of children for surgery: the importance of parental involvement. Patient Educ Couns. 2007;65[1]:34-41. 16. Al-Yateem N, Brenner M, Shorrab AA, Docherty C. Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: a randomized controlled non-inferiority trial. Child Care Health Dev. 2016;42[4]:572-81. 17. Li HC, Lopez V. Effectiveness and appropriateness of therapeutic play intervention in preparing children for surgery: a randomized controlled trial study. J Spec Pediatr Nurs.
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2008;13[2]:63-73. 18. Verschueren S, van Aalst J, Bangels AM, et al. Development of CliniPup, a serious game
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aimed at reducing perioperative anxiety and pain in children: mixed methods study. JMIR Serious Games. 2019;7[2]:e12429, doi:10.2196/12429.
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19. Bul K CM, Kato PM, Van der oord S, et al. Behavioral Outcome Effects of Serious Gaming as Attention-Deficit/Hyperactivity Disorder: A
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20. Buffel C, van Aalst J, Bangels AM, et al. A Web-based Serious Game for Health to Reduce Perioperative Anxiety and Pain in Children (CliniPup): Pilot Randomized Controlled Trial.
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JMIR Serious Games. 2019; 7 [2]:e12431. doi:10.2196/12431. 21. Von Baeyer CL Children’s self-reports of pain intensity: Scale selection, limitations and
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interpretation. Pain Res Manage 2006; 11(3): 157-162. 22. Berghmans JM, Poley MJ, van der Ende J, Weber F, Van de Velde M, Adriaenssens P, Himpe D, Verhulst FC, Utens E. A Visual Analog Scale to assess anxiety in children during anesthesia induction (VAS-I): Results supporting its validity in a sample of day care surgery patients. Paediatr Anaesth. 2017 Sep;27(9):955-961. doi: 10.1111/pan.13206. 23. Jenkins BN, Kain ZN, Kaplan SK, Stevenson RS, Mayes LC, Guadarrama J & Michelle A. Fortier MA. Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery. Pediatric Anesthesia 25 (2015) 738–745. 24. Spielberger, C. State-Trait Anxiety Inventory For Adults: Manual, Menlo Park: Mind Garden; 1983. 25. Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. Journal of Chiropractic Medicine. 2016;15:155–63.
Journal Pre-proof 26. Vet HCWd, Terwee CB, Knol DL, Bouter LM. When to use agreement versus reliability measures. J Clin Epidemiol. 2006:1033–9. 27. Twisk JWR. Inleiding in de toegepaste biostatistiek: Reed Business; 2014. 28. Fleming TM, Bavin L, Stasiak K, Hermansson-Webb E, Merry SN, Cheek C, et al. Serious Games and gamification for mental health: current status and promising directions. Front Psychiatry. 2016;7:215. 29. Fernandes SC, Arriaga P, Esteves F. Providing preoperative information for children undergoing surgery: a randomized study testing different types of educational material to
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LEGENDS TO THE TABLES AND FIGURES Table 1: Baseline study participants characteristics Table 2: Linear Mixed Model analysis for VAS anxiety (VASa) This table is an overview of the differences in estimated mean VASa between the different groups at different study timepoints. Significant P-values are indicated in bold. Group A: Intervention group (Clinipup®), Group B: Comparison group (Empty game); Group C:
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Control group (no game)
Table 3: Correlation between VAS scores for anxiety (VASa) and VAS scores for pain (VASp) on
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different study timepoints
Significant P-values are indicated in bold
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Figure 1: Study design flowchart
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This table shows the Spearman correlation coefficient with corresponding P-value at each timepoint.
Abbreviations: VAS = Visual Analogue Scale; STAI = State-Trait Anxiety Inventory; PHBQ-AS = Post
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Hospitalization Behaviour Questionnaire for Ambulatory Surgery Figure 2: Patient recruitment and participation flow diagram
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Figure 3: Estimated mean VAS scores for anxiety (VASa) at different study timepoints Statistically significant value (A versus C) is indicated with horizontal bar and P-value
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Error bars represent the 95% confidence intervals around the estimated means Group A: Intervention group (Clinipup®), Group B: Comparison group (Empty game), Group C: Control group (no game)
T0: baseline, at home; T1: after playing, at home; T2: at hospital admission; T3: postoperatively, before discharge; T4: one week postoperatively, at home. Figure 4: Estimated mean VAS scores for pain (VASp) at different study timepoints Error bars represent the 95% confidence intervals around the estimated means Group A: Intervention group (Clinipup®), Group B: Comparison group (Empty game), Group C: Control group [no game] T0: baseline, at home; T1: after playing, at home, T2: at hospital admission; T3: postoperatively, before discharge; T4: one week postoperatively, at home.
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Table 1: Baseline study participants characteristics Total sample
Intervention
Comparison
Control
(n=72)
Group A
Group B
Group C
(n=25)
(n=22)
(n=25)
7.32 (2.0)
7.36 (1.8)
7.64 (2.3)
7.00 (1.8)
Male, n (%)
49 (68.1)
17 (68.0)
16 (73.0)
16 (64.0)
Female, n (%)
23 (31.9)
8 (32.0)
6 (27.0)
9 (36.0)
Dentistry
31 (43.1)
4 (12.9)
Urology
20 (27.8)
11(55.0)
Ear-Nose-Throat
15 (20.8)
General surgery
6 (8.3)
Age in years, mean (SD)
Surgery type, n (%)
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Child’s gender
16 (51.6)
4 (20.0)
5 (25.0)
7 (46.7)
5 (33.3)
3 (20.0)
3 (50.0)
2 (33.3)
1 (16.7)
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11 (35.5)
Journal Pre-proof Table 2: Linear Mixed Model VAS anxiety (VASa)
B compared to C Baseline, at home [T0] After playing, at home [T1] Hospital admission [T2] Before discharge [T3] 1 week postoperatively [T4]
-
4.5
2.4
-
4.1
1.3
-
0.8
1.1
-
2.0
A
B
C
2.8
2.5
-
1.9
2.7
-
2.4
2.5
-
1.3
1.2
-
1.1
1.2
A
B
-
2.5
C
-2.60 -1.66 0.51
-3.57; 0.16 -4.31; 0.89 -3.90; 0.58 -0.91; 1.93
4.5
-
2.7
4.5
-
2.5
4.1
-
1.2
0.8
-
1.2
2.0
0.07 0.003 0.14 0.47
-0.85
-2.32; 0.63
0.25
95% CI
Pvalue
0.27 -0.80 -0.14 0.13
-1.63; 2.17 -2.56; 0.95 -2.47; 2.20 -1.41; 1.67
-0.07
-1.68; 1.55
95% CI
-1.98 -1.80 -1.53 0.38
-0.78 ®
-3.89; 0.07 -3.55; 0.04 -3.60; 0.54 -1.00; 1.77 -2.41; 0.84
C
3.0
-
4.1
2.2
-
4.1
2.0
-
3.6
2.3
-
1.3
1.1
-
1.8
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1.9
-1.71
B
A
B
C
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4.5
A
2.3
-
2.2
2.4
-
2.0
2.2
-
2.3
1.8
-
1.1
1.2
-
0.78
3.0
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Baseline, at home [T0] After playing, at home [T1] Hospital admission [T2] Before discharge [T3] 1 week postoperatively [T4]
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Pvalue
95% CI
0.36 0.91
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A compared to B
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Baseline, at home [T0] After playing, at home [T1] Hospital admission [T2] Before discharge [T3] 1 week postoperatively [T4]
Estimated Mean VASa corrected
UNCORRECTED
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A compared to C
Estimated Mean VASa uncorrected A B C
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ANXIETY
0.87 0.93
Pvalue 0.04 0.04 0.14 0.58 0.34
A
B
C
-
2.3
4.1
-
2.4
4.1
-
2.2
3.6
-
1.8
1.3
-
1.2
1.8
CORRECTED -1.17 -1.91 -1.60 1.01
95% CI -3.22; 0.88 -3.76; 0.05 -4.03; 0.83 -0.34; 2.37
Pvalue 0.26 0.04 0.19 0.14
-0.72
-2.39; 0.95
0.39
95% CI
Pvalue
0.68 -0.22 -0.15 0.58
-1.34; 2.70 -2.07; 1.63 -2.65; 2.35 -0.86; 2.02
0.50 0.81 0.90 0.42
-0.07
-1.82; 1.69
0.94
95% CI
Pvalue
-1.85 -1.69 -1.45 0.44 -0.65
-3.80; 0.09 -3.45; 0.07 -3.57; 0.68 -0.80; 1.68 -2.32; 1.01
0.06 0.06 0.18 0.48 0.44
Note: A = Intervention Group (CliniPup ); B = Comparison Group (Empty game); C = Control Group (no game)
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Table 3: Correlation between VAS anxiety [VASa] and VAS pain [VASp] on different timepoints P-value
Baseline [T0]
0.197
0.19
After playing [T1]
0.255
0.04
Hospital admission [T2]
0.340
0.04
Before discharge [T3]
0.299
0.06
1 week postoperatively [T4]
0.512
0.00
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Spearman correlation coefficient
Figure 1
Figure 2
Figure 3
Figure 4