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Therapeutic Play Intervention Mary W. Stewart, PhD, RN RANDOMIZED CONTROLLED TRIAL (RCT) is the gold standard in research. However, few nurse scientists conduct RCTs, when compared with other types of research designs. One legitimate explanation is the lack of true control when working in a clinical setting. Manipulating mice and controlling human patients are obviously two very different challenges. Nevertheless, as our health care system demands cost-effective, clinically significant, and feasible interventions, nurses have the opportunity to make important contributions as lead investigators in RCTs. The following two articles present different perspectives of a single trial, led by a team of nurse researchers from Singapore, Australia, and China. Therapeutic play intervention on children’s perioperative anxiety, negative emotional manifestation, and postoperative pain: A randomized controlled trial by He H-G, Zhu L, Chan W-CS, et al. Journal of Advanced Nursing. 2015; 71:1032-1043. Background and Purpose Children and their parents endure at least some angst when the child is scheduled for surgery. This first of two reports focuses on the children’s experience. Specifically, a child’s anxiety surrounding surgery can lead to negative emotional manifestations, including lack of cooperation with health care providers in the perianesthesia settings. In addition to anxiety and subsequent expressions, children often have pain postopera-
Mary W. Stewart, PhD, RN, Professor and Director of PhD Program, School of Nursing, University of Mississippi Medical Center, Jackson, MS. Conflict of interest: None to report. Address correspondence to Mary W. Stewart, School of Nursing, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216-4505; e-mail address:
[email protected]. Ó 2016 by American Society of PeriAnesthesia Nurses 1089-9472/$36.00 http://dx.doi.org/10.1016/j.jopan.2016.07.001
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tively. The authors reported inadequate management of pain in some children undergoing surgery in Singapore. Therapeutic play has been shown to reduce children’s anxiety, increase their sense of control, and educate regarding anticipated procedures or hospitalizations. This approach is not new. Unfortunately, the authors found only six RCTs that examined effectiveness of therapeutic play in children having surgery. Among those six, the findings and conclusions were inconsistent; thereby, leaving a gap in the knowledge of the effects of therapeutic play in this vulnerable population. The overall aim of this study was to examine the efficacy of a therapeutic play intervention on children undergoing elective, inpatient surgery, and their parents. The purpose of this first report was to look closely at the outcomes related to the children: perioperative anxiety, negative emotional manifestation, and postoperative pain. The researchers hypothesized that children who received the intervention would report less anxiety, fewer negative emotional signs, and less pain when compared with a control group that did not receive the intervention. Methodology As noted earlier, researchers designed a longitudinal, two-group RCT. One group received the therapeutic play intervention, and the other (control) group received the standard of care plus some educational materials. As potential participants were identified and recruited, they were randomly assigned to one of the two groups. Measures were taken at three points: 3 to 7 days before surgery; preoperatively on the day of surgery; and 24 hours postoperatively. Recruitment took place for more than a period of 21 months from 2011 to 2013. Inclusion criteria for the children were 6 to 14 years old, scheduled for inpatient elective surgery, fluent in English or Mandarin, with at least one parent present in the hospital. Children with a history of previous
Journal of PeriAnesthesia Nursing, Vol 31, No 5 (October), 2016: pp 452-456
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surgeries, long-term illness or pain, or disabilities were excluded from the study. Consistent with good intervention research, the authors had previously conducted a pilot study to determine the appropriate sample size needed for the RCT. They also accounted for a 20% attrition rate. On the basis of that analysis and their desire to detect a medium effect of the intervention, they aimed to recruit 106 children or 53 in each group. Children who were randomly assigned to the intervention (treatment) group participated in a 1-hour session with a researcher who guided the therapeutic play. The child received a manual that included images and information about medical equipment related to their upcoming operation. This took place at the outpatient clinic or at the child’s home, depending on parent preference. The child watched a video on preparing for the operation. They looked at photographs of the hospital and surgery environment and did return demonstrations on some procedures, eg, receiving anesthesia therapy, using dolls. Parents could participate in the intervention, but most of them sat quietly when the researcher and child interacted. The families received an oxygen mask and intravenous cannula (without the needle) to take home. Outcome measures were collected using the following: 1. Demographic information was self-reported by children and parents. Clinical information, eg, type of surgery, duration of surgery, use of analgesia 24 hours postoperatively, was documented from the child’s medical record. 2. Perioperative anxiety: State Anxiety Scale for Children (SAS-C), a short form of the State-Trait-Anxiety Inventory for Children, captured state anxiety. Five of the 10 items on the SAS-C assess negative emotions; the other five assess positive emotions. Using a scale of 1 to 3, scores ranged from 10 to 30, with higher scores representing higher levels of anxiety. Children were able to choose the English or Mandarin version of the SAS-C to answer the 10 questions.
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3. Negative emotional manifestations: Children’s Emotional Manifestation Scale (CEMS) measured this outcome. The CEMS captures five emotional behaviors: facial expression, vocalization, activity, interaction, and level of cooperation. Using a scale of 1 to 5, the total scores ranged from 5 to 25, with high scores indicating greater severity of negative emotional manifestations. Nurse researchers recorded these findings. 4. Postoperative pain: The Numeric Rating Scale measured pain intensity from 0 (no pain) to 10 (worst pain). The participating hospital provided the list of scheduled surgeries to the researchers. Parents of potential patient participants were contacted via phone and mail. If eligible and agreeable, children were randomly assigned to one of the two groups, and they were told of their allocation via phone. At time one, 3 to 7 days before surgery, the treatment group completed demographics and participated in the intervention. Those in the control group completed their baseline data through the mail. On the day of surgery, measure time two, all child participants completed the SAS-C. In addition, research assistants, blinded to group allocation, completed the CEMS on all child participants. Likewise, postoperative pain data were collected approximately 24 hours after surgery or before discharge, whichever came first. Data were analyzed using popular statistical software. Descriptive statistics and scores on the three study outcomes were reported. In addition, the authors included a diagram depicting the recruitment and measurement points. Although 53 children were initially in the experimental group and received the therapeutic play intervention, five were excluded because of postponement of surgery (n 5 1), diagnosis of autism (n 5 1), previous surgeries (n 5 1), or family choice (n 5 2). In the control group, six of the 53 children were excluded because of delayed surgery (n 5 3), canceled surgery (n 5 1), previous surgery (n 5 1), or family choice (n 5 1). Therefore, a total of 95 participants were included in the analysis.
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Results Children ranged in age from 6 to 14 years, with a mean of 9.74 years. No significant differences were found in demographic or clinical characteristics between the two groups. Researchers proceeded with reporting the findings on perioperative anxiety. Children who participated in the therapeutic play intervention (treatment) group had a decrease in percentage change of state anxiety levels from baseline (3 to 7 days before surgery) to the day of surgery. Those in the control group had a slight increase in this percentage. Both groups had a statistically significant decline in anxiety from the preoperative measure on the day of surgery to the third measure, approximately 24 hours after surgery. No other statistical findings reached significance on this outcome. In regard to negative emotional manifestations, children in the treatment group scored significantly lower on the CEMS scores before anesthesia compared with those in the control group (F 5 13.452, P , .01). Finally, pain intensity scores for each child showed that the maximum mean pain score at the 24-hour postoperative measurement was 1.5 points lower in the treatment group (2.11) compared with the control group (3.60). This was statistically significant (F 5 10.536, P , .01). Researchers used the appropriate statistical tests to control for potentially confounding variables in all analyses. For the pain measure, they controlled for the type of surgery, body weight, and use of analgesia, thus adding validity to their findings. Conclusions Children who received the therapeutic play intervention had fewer negative emotional manifestations before anesthesia and lower postoperative pain when compared to the control group, who did not receive the intervention. Children in the treatment group also reported lower levels of anxiety than those in the control group, although these differences were not statistically significant. The clinical significance of interventions that reduce children’s state anxiety, negative emotional manifestations, and postoperative pain are worthy of future study.
Although this was an RCT, limitations still exist. Response bias is always a risk when using selfreported measures, such as those in this study capturing anxiety and pain. The use of objective measures, such as cortisol, would strengthen subsequent projects. The children’s state anxiety may have been effected if they had been allowed to visit the operating suite and touch actual objects, as opposed to seeing pictures. A final limitation was the lack of control for nonpharmacological methods for postoperative pain. A mixed-method study of effects of a therapeutic play intervention for children on parental anxiety and parents’ perceptions of the intervention by He H-G, Zhu L, Chan W-CS, et al. Journal of Advanced Nursing. 2015;71:1539-1551. Background and Purpose The background of this article is similar to the previous study, which was published in the issue immediately preceding this one: the importance to nursing centers on the effect of a therapeutic play intervention in children undergoing elective inpatient surgery in Singapore. However, the purpose of this article was to examine the intervention’s effect on parents’ perioperative anxiety, relationships between parents’ and children’s anxiety, and parents’ perceptions of the intervention. Therefore, three research questions guided this study: 1. Will parents who accompany their children in the therapeutic play intervention report lower levels of anxiety than parents in the control group? 2. What are the relationships between perioperative anxiety of parents and their children? 3. What are the parents’ perceptions of the intervention used with their children? Methodology As indicated in the title, the researchers expanded the RCT to include a qualitative piece that explored the parents’ perceptions of the therapeutic play intervention experienced by their children. Parents of the children who participated in the RCT were also considered participants and completed the State Anxiety Scale for Adults (SAS-A) at baseline, preoperatively on the day of surgery, and approximately 24 hours after surgery
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or before discharge, whichever came first. In addition, parents in the treatment group were interviewed about their perceptions of the intervention. Parental demographic information was also collected at baseline. Twenty items comprise the SAS-A: 10 assessing negative feelings and 10 assessing positive feelings. Scores are reported from 1 to 4 with total scores ranging from 20 to 80. Higher scores indicate higher anxiety. Like the children, parents selected the English or Mandarin version of the SAS-A to complete. For the qualitative arm of this study, the research assistant, who conducted the therapeutic play intervention, conducted a process evaluation using semistructured interviews. An interview guide facilitated the discussion. Questions are paraphrased: 1. Was the intervention useful in reducing anxiety for you and your child about the surgery? 2. Did the intervention increase your knowledge about the anesthesia procedures? 3. Was it worth the extra time for your child to receive the intervention? 4. Identify the strengths and weaknesses of the intervention. Responses were followed up with appropriate probes to ascertain as much information as possible concerning parental perceptions. The interviews lasted about 25 minutes and were audio-recorded for later transcription. Researchers followed well-regarded steps in thematic analysis. Results Parents ranged in age from 33 to 59 years, with a mean age of 41.5 years. Like the groups of children, the two groups of parents did not differ on demographics. All parents had an increase in anxiety from baseline to the preoperative measure on the day of surgery, followed by a decrease from preoperative to 24 hours after surgery. No statistical differences were found between the two groups of parents. On the relationship between parents’ and children’s anxiety, significantly positive relationships were noted between parents’ and children’s baseline anxiety. In other words, anxious parents had anxious children.
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Twenty-two parents were interviewed in the process evaluation component. They ranged in age from 33 to 53 with a mean of 40 years. Most were mothers (90.9%) and Singaporean (77.3%) or permanent residents of Singapore (18.2%). Seventy-percent were Chinese. Educational levels varied, with 35% not completing high school, 25% earning a diploma, and 35% completing college. Family income ranged from US $2,362 to US $4,000 per month, with more than 80% having less than US $3,149 per month. Four themes were identified in the analysis of the qualitative data: (1) reducing anxiety; (2) increasing knowledge and understanding about anesthesia procedures; (3) worthiness of attending the intervention; and (4) suggestions for improvement. Overall, those interviewed perceived the therapeutic play was a benefit, reduced anxiety, and raised awareness of upcoming procedures. Parents agreed that the time participating in the intervention was a good investment, although most of them did not actively engage with their children during the intervention. Suggestions included group play and incorporating pictures of doctors with and without surgical masks. Conclusions Parents were very positive about the therapeutic play intervention and perceived it to be a benefit to both them and their children. In addition to the limitations noted in review of the previous study, future plans might include exploring perceptions of participants in the control group who received routine care. Another consideration would be to have different researchers conduct the intervention and the process evaluation. In the end, the rigor of this RCT with a qualitative component of parental perceptions adds convincing work ready to be tested in other populations to strengthen reliability, and consequently generalizability to children and parents who face surgery. Perianesthesia Nursing Implications As perianesthesia nurses, we have all encountered children undergoing surgery and dealt with the range of emotions by both the patient and his or her parents. We have different approaches to help families through this tense time. If we are
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honest, we may even target certain nurses who are ‘‘better with kids’’ than other nurses, when making patient assignments. Although anxiety, negative emotional manifestations, and postoperative pain are common, minimizing them would only benefit those involved. These articles detailed a well-designed study that could be replicated fairly easily. Researchers did many things correctly. Specifically, they conducted a pilot study to help determine the sample size and intervention feasibility. They reported standardized training for research assistants and standardization of the time or dose (1 hour) of the intervention. Previous studies were cited that helped build the foundation for this project, so that the evolution of different aspects of the RCT can be followed. Of great importance in any quantitative study is inclusion of reliability and validity data of the instruments. In this case, all the instruments had strong psychometric properties. Regarding the qualitative phase, researchers attended carefully to assuring rigor of the findings.
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They used audio recordings and transcription for credibility; thick descriptions with direct quotes for transferability; an audit trail including field notes for dependability; and the audit trail, reflexivity, and triangulation for confirmability. In summary, these researchers have provided us with an example of how to do a mixed-method study, including an RCT component, well. What this means to perianesthesia nurses is clear. Nonoptimal pain management is not limited to Singapore. Anxiety and its effects for both parents and children undergoing surgery are phenomena of central interest to nursing. The negative emotional displays as well as pain and anxiety are facets of everyday perianesthesia nursing practice. Although we use existing actions to minimize the undesirable aspects of the surgical and anesthesia experience, we have yet to eliminate them. In some cases, we struggle to manage them effectively. Knowing what works in other populations, as tested by rigorous research, opens the prospect of moving closer to our common goal—taking the best care possible of those entrusted to us.