The effect of an information brochure on patients undergoing gastrointestinal endoscopy: A randomized controlled study

Patient Education and Counseling 64 (2006) 173–182 www.elsevier.com/locate/pateducou

The effect of an information brochure on patients undergoing gastrointestinal endoscopy: A randomized controlled study Florence J. van Zuuren a, Mieke Grypdonck b,c,*, Eveline Crevits c,d, Cressy Vande Walle c,e, Tom Defloor c a

University of Amsterdam, Department of Clinical Psychology, Amsterdam, The Netherlands b Department of Nursing Science, University of Utrecht, The Netherlands c Department of Nursing Science, Ghent University, Belgium d General Hospital St.-Lucas, Ghent, Belgium e General Hospital Maria-Middelares, Ghent, Belgium

Received 24 August 2005; received in revised form 20 December 2005; accepted 28 December 2005

Abstract Objective: The aim of the present study was to test the potential beneficial effects of an information brochure on undergoing a gastrointestinal endoscopy for the first time. The information provided was based on self-regulation theory, and patients could restrict themselves to reading the summary only. Methods: Patients were randomly assigned to an experimental group receiving the brochure at least 1 day before the gastroscopy (N = 47), or to a control group not receiving the brochure (N = 48). Results: The results show that all experimental subjects, except one, fully read the brochure. Those receiving the brochure experienced less anxiety before the gastroscopy and, afterwards, they reported greater satisfaction with the preparation for it. With regard to coping style there were some small moderating effects into the direction expected: low blunters (those not seeking distraction under impending threat) as compared to high blunters showed extra reduced anxiety after reading the brochure. They also tended to read the brochure more often. High monitors (those seeking information under impending threat) receiving the brochure showed reduced anxiety during the gastroscopy as compared to low monitors (tendency). Conclusion: We conclude that providing patients with the developed brochure constitutes an efficient, beneficial intervention. Practice implications: The brochure could easily be implemented in standard practice without the necessity to take the patient’s coping style into account. # 2006 Elsevier Ireland Ltd. All rights reserved. Keywords: Information brochure; Gastrointestinal endoscopy; Coping style; Preparation; Patient satisfaction

1. Introduction Gastrointestinal endoscopy is a frequently and widely used medical examination, but for many patients it constitutes an unpleasant medical event. Preventing or alleviating high anxiety during the examination is important, not only because of its unpleasantness per se, but also because anxiety may * Correspondence at: Maria Theresiastraat 87, B-3000 Leuven, Belgium. Tel.: +32 16 22 04 05; fax: +32 9 204 50 02. E-mail address: [email protected] (M. Grypdonck).

prolong the procedure and increase the probability of sideeffects. Conscious sedation has been shown to reduce anxiety and to improve tolerance for endoscopy [1]. But negative sideeffects have been reported as well [2]. In order to promote cost-effectiveness, attempts have been made to predict which patients can and which patients cannot undergo gastro endoscopy comfortably without conscious sedation [3]. In some countries conscious sedation is not provided standardly, among these our country of interest: Belgium. Apart from sedation, information has been considered a key factor in adaptation to an aversive medical examination.

0738-3991/$ – see front matter # 2006 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.pec.2005.12.014

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Optimal information provision is all the more important since the recent established patients’ legal right – in many countries – to be informed fully and in advance about a medical examination, and to give their consent on the basis of this information. Earlier studies in other countries showed that information has a positive effect on undergoing a gastrointestinal endoscopy [4,5], although these effects were sometimes small [6]. Positive effects were also found for additional behavioral and cognitive instructions [7,8], and, in case of colonoscopy, for self-selected music [9]. The present study investigates the effects of a newly developed information brochure on undergoing a gastro endoscopy for the first time. Under the next heading we describe the theoretical basis of the study.

2. Theoretical framework and hypotheses In developing patient information guidelines can be found in the self-regulation theory of Leventhal and Johnson [10,11]. This theory has its origin in the context of informing patients pre-operatively and states that information may create internal schemata which, in their turn, may facilitate adaptation. Particularly the combination of sensory and procedural information would be most effective in generating these schemata which enable the individual patient to concentrate on necessary coping behaviors. More recently, self-regulation theory, now referred to as ‘objective information theory’ has been successfully applied in preparing patients for and improving adaptation to a wide variety of ‘threatening events’ such as radiation therapy [12,13], recent diagnosis of cancer [14] and surgical pain [15]. Another theoretical notion with regard to information provision has been to attune the type and amount of information to individual needs. In this area, dispositional cognitive coping styles have received much attention, particularly Miller’s monitoring–blunting model concerning the processing of health information [16–18]. In this model, monitoring is defined as the tendency to attend to threatening information under impending threat. This implies that, with regard to a health threat, high monitors are highly concerned about their risks, scan for potentially threatening health information, amplify threatening cues and worry about these, whereas low monitors abstain from engaging in these behaviors [19]. Blunting, which has been shown to be an independent dimension [17], is defined as avoiding threatening information and actively seeking distraction under impending threat. High blunters, as opposed to low blunters, are characterized by postponing confrontation with potentially threatening information, minimizing informational uptake and engaging in distractioning cognitions and behaviors instead. Miller hypothesized that information provision concerning a medical threat will be more effective when it is tailored to the way individuals habitually process health information [16,17,19]. The type of information to be provided to high

monitors should ideally be detailed and specific about risks, and offering strategies to reduce anxiety. For high blunters, effective health information should be short and basic, and deprived of threatening details [19]. Studies have related individual differences such as coping style to the provision or the effect of information [13] or advocate taking coping style into account [20]. Initial studies in medical settings showed better adaptation in patients when information provision was attuned to their monitoring–blunting coping style (e.g. [21]). The recent study of Williams-Piehota et al. showed that oral and written information matched to a person’s coping style is more effective in encouraging mammography utilization than mismatched information, particularly for blunters [22]. With regard to undergoing a gastrointestinal endoscopy, Gattuso et al. were the first to study the effects of type of information in relation to monitoring–blunting coping style and found that for high blunters extensive procedural information (=mismatched information) could be counterproductive [23]. For colonoscopy favorable results were reported when information seekers received extra (i.e. sensory) information [24]. van Vliet et al. prepared patients undergoing a gastrointestinal endoscopy for the first time by oral information varying in extensiveness and attuned to their coping style [25]. Given the time consuming aspect of their intervention, the results were disappointing when compared to the standard oral information provided by hospital staff. In addition, the hypothesized relation with coping style could not be established. What the study did show was the importance of the coaching role of the nurse. For reasons of timing and efficiency we decided to develop written in stead of oral information in the form of an information brochure to be sent to each patient and arriving at least 1 day before undergoing a gastrointestinal endoscopy. In comparison with oral information, written information is earlier disposable without necessitating the patient to make an additional trip to the hospital and it is less dependent on the particular circumstances and on the motivation and skills of the nurse. In order to protect patients with low information needs (high blunters) against too extensive information, the brochure offered the opportunity to read the summary only. If the beneficial effect of this type of intervention becomes evidence based, implementation of the brochure in standard practice might be considered. The aim of the present study was to test the potential beneficial effect of the newly developed information brochure on a variety of outcome measures in a randomized controlled design with one experimental and one control group. More specifically, three hypotheses were tested: I. Patients receiving the information brochure experience less anxiety just before and during the medical examination than patients not receiving the information brochure. They also worry less before the examination and evaluate the examination more positively.

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In addition, they report greater satisfaction with the information provided. II. There is a moderating effect of cognitive coping style on the relation between yes/no brochure and the dependent variables enumerated in Hypothesis I: high monitors benefit more from the positive effects of the information brochure than low monitors, and the same applies to low blunters as compared to high blunters. III. High monitors in the experimental group as compared to the low monitors in this group make more frequent and more thorough use of the information brochure, and the same applies to low blunters as compared to high blunters. In addition, we made an inventory of actual use of the information brochure by all subjects in the experimental group and explored relations between monitoring, blunting and other variables for the whole sample.

3. Methods and materials 3.1. The experimental intervention In developing the information brochure we were guided by self-regulation theory [10], the monitoring–blunting model [16–19] and the results of the study of van Vliet et al. [25]. Apart from this, we made sure that the information was attuned to the medical protocol of the hospital involved. In accordance with self-regulation theory we combined different types of information in the brochure [10,11]. First, we generated sensory information meant to create a frame of reference for potential sensations, enabling the patient to decide whether his or her actual sensations fall within the range to be normally expected. We took special care to provide a description as neutral as possible for usually negatively experienced sensations as, for example, gagging. Second, we developed procedural information to increase predictability and personal adaptation to the medical examination. Third, in order to further increase adaptation, we devised coping instructions, for example the advice not to swallow anymore once the scope has entered the gullet. Fourth, additional practical information was provided to prevent the patient from getting involved unnecessarily in an uncomfortable situation. An example here is the advice not to drive home oneself in case one received sedation but, instead, asking the partner or a friend to drive. Finally, the importance of the coaching role of the nurse [25] has been incorporated into our information by stating that ‘the nurse will stay with you throughout the whole medical examination and you can count on him/her for support’. According to the recommendations of the monitoring– blunting model [16–19] we composed rather detailed information in an extended text. This text was particularly meant for high monitors and for low blunters. For high blunters and low monitors we devised a framed summary

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with basic information at the end of the brochure (‘basic information at a glance’). At the beginning of the brochure we inserted a framed, short text inviting the reader to choose between reading the whole brochure and restricting oneself to the summary at the end. The reader was assured that no necessary information would be missing in case one should limit oneself to the summary. So, with regard to this information intervention, it is the patient who decides how to make use of it. The result is a handy, well-ordered, small format seven page leaflet. It was made sure that the subjects in the experimental group received the brochure – at home or in hospital-several days or at least one whole day before their gastrointestinal endoscopy would take place, because information provided just before the medical examination may be too late to have a reassuring effect [25]. 3.2. Subjects The experiment was carried out at the ambulant department gastroenterology of a general hospital in Belgium. Approval for the study was obtained from the ethical committee of this hospital. At the moment an appointment for gastrointestinal endoscopy was made for them, all patients older than 18 years and fluently speaking Dutch were asked to participate in the study. Almost all patients were ambulant and were referred by their general practitioner. Four patients were hospitalized and had a referral from other departments in the hospital. After their oral consent, all subjects received an informed consent letter to be returned with their signature. From the 111 patients originally invited, five refused. All others returned their signed informed consent letters. Further exclusion criteria led to additional decrease in sample size: undergoing a gastrointestinal endoscopy not for the first time or with emergency (n = 4), being physically unable to participate (n = 3) and having received the information brochure shorter than 1 day before the medical examination would take place (n = 4). Therefore, 95 subjects participated in the study. Their mean age was 49.1 years (S.D. = 16.9; range 19–83) and there were 32 men and 63 women. 3.3. Measures For the dependent variables the following measuring instruments were used. First, the Dutch well-known and well validated adaptation of Spielberger’s State Trait Anxiety Inventory, the ‘ZBV’ [26] was used to measure state anxiety during the waiting period, just before the gastrointestinal endoscopy. In the present study, Cronbach’s alpha for the state anxiety subscale was high (0.95) and is in agreement with the internal consistency reported elsewhere [26]. State anxiety was also measured by a 10 cm Visual Analogue Scale, at two points in time: just before the gastrointestinal endoscopy (‘Anxiety-VAS before’), and directly after it, retrospectively referring to feelings of anxiety during the

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endoscopy (‘Anxiety-VAS after’). Scores have a total range from 0 to 100, with a high score indicating high anxiety. Second, we measured degree of worrying by a 10 cm Visual Analogue Scale, in the waiting room (‘Worrying-VAS before’). Third, we measured the experience of undergoing the endoscopy with the 12-item Experience of Gastrointestinal endoscopy scale, the ‘EG’ [25,27]. Total scores may range from 12 to 60, with – in contrast to the other variables – a high score indicating a positive experience. van Vliet et al. report adequate content and construct validity, and good internal consistency with Cronbach’s alpha = 0.91 [25,27]. In the present study alpha was 0.92. Fourth, in the waiting period and again after the endoscopy, subjects completed a questionnaire with items about their satisfaction with the preparation, and, after the endoscopy only, about their satisfaction with the information received. With regard to information, the experimental group answered additional written questions about the information brochure (its helpfulness, timing, and the thoroughness and frequency they had made use of it). All these questions had fixed answer categories. We included the trait anxiety scale of the ZBV [26] as a control variable to be measured several days after the gastrointestinal endoscopy. Here, Cronbach’s alpha turned out to be 0.91. Other control variables were obtained from the patients’ medical records (see Table 1). These include sex, age, educational level (three categories), yes or no IVsedation (sedation was provided when a patient was restless, or asked for it explicitly), and being ambulant or hospitalized. In order to study the possible moderating effect of the monitoring and blunting coping styles, we asked the patients to fill in the Dutch version of the Threatening Medical Situations Inventory (TMSI) some time after the endoscopy [28]. This inventory measures the monitoring and blunting

coping styles in medical settings. It consists of four vignettes of threatening medical situations each followed, randomly, by three monitoring and three blunting alternatives to be answered on five-point scales. Total scale scores range from 12 to 60, and in different Belgian samples median Monitoring scale scores circle around 33, median Blunting scale scores around 36 [29]. Validity and reliability of both TMSI-scales have been shown to be good [28,29]. In the present study, Cronbach’s alpha is 0.85 for the monitoring scale and 0.65 for the blunting scale. This latter alpha is less satisfactory than in both studies just mentioned [28,29], but still considerable in the light of the internal consistencies of other blunting scales [17,30]. We decided to be extra restrictive in the interpretation of results concerning the blunting scale. For further analyses, subjects were divided into high monitors and low monitors on the basis of the median monitoring score, and into high blunters and low blunters on the basis of the median blunting score. For reasons of comparability, we used the medians reported in the large study of van Vliet et al. [25]: 32 for the monitoring scale, and 36 for the blunting scale. 3.4. Design and procedure In a pilot study with 21 subjects (not included in the main study) we tested out the procedure and the measuring instruments. This resulted in a few adaptations with regard to subject instruction and time schedule. In the main study, subjects (N = 95) were randomly assigned to the experimental group receiving the information brochure at home at least 1 day before the endoscopy would take place (n = 47), or to the control group not receiving the information brochure (n = 48). In order to increase internal validity, we used a stratified randomization

Table 1 Overview of variables and times of measurement Type of variable

Variable

Before GSa: at home

Independent

Information brochure

X (exp. gr)

Control

Sex Age Educational level Trait anxiety IV-Sedation Ambulant/hospitalized

X X

Moderator

Monitoring Blunting

Dependent

State anxiety Anxiety-VAS Worrying-VAS Experience gastroscopy Satisfaction with preparation Satisfaction with information Use of information brochure

a

GS: gastrointestinal endoscopy.

Before GS: waiting room

After GS

X X X X X X X X X X

X X (retro) X X X X (exp. gr)

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procedure with respect to the variables ‘being ambulant versus hospitalized’, sex and age (being under 65 versus being 65 or older). This procedure implies that, within each thus specified group, a table containing the numbers ‘0’ and ‘1’ in random order determined to which group the subject was assigned. When a subject arrived for the gastrointestinal endoscopy appointment, there was 15 min time to fill in the questionnaires. Subsequently, each subject received the oral standard information provided by a hospital nurse. This nurse stayed with the subject and coached him or her during the endoscopy. All staff members involved were blind with respect to condition. A separate check was done for the one coaching nurse who was acquainted with the study and therefore, possibly, with the subjects’ condition, but no differences in dependent variables were found. Upon leaving, each subject received a stamped, pre-addressed envelope with some more questionnaires to be filled in either at the hospital or at home, but within 7 days. All patients returned their questionnaires. 3.5. Statistical analysis Potential group differences on control and moderator variables were tested with t-tests (continuous variable) or x2 (nominal variable) with a = 0.05, two-tailed; Fisher’s exact probability was computed in case of a dichotomous variable with very small cells. For differences between the experimental and the control group on the dependent variables we made use of t-tests, or, when scores were not normally distributed, Mann–Whitney U-tests. Because here we predicted a direction, these tests were one-tailed. In case of a nominal variable, x2-tests were used, or Fisher’s exact probability (small cells). In order to get more insight into interrelations between dependent variables, Pearson correlations were computed, and the same was done for the relation between monitoring (or blunting) and the other variables. Finally, analyses of variance were carried out in order to the test de hypothesis about the moderating effect of monitoring (high/low) and blunting (high/low) on the relation between the independent variable (group) and the dependent variables.

4. Results 4.1. Group equality on control and moderator variables Table 2 shows that there are no significant differences between the experimental and the control group on control and moderator variables. With regard to trait anxiety and monitoring, there is a tendency that the control group scores higher. For monitoring, this tendency disappears when groups are formed on a dichotomous basis (high versus low monitoring). These results imply that, formally speaking, there is equality among the experimental and the control group on all control and moderator variables. Nevertheless, in

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a separate analysis, we will control for the tendency found for trait anxiety – a tendency that favors the experimental group. 4.2. Effects of information brochure Table 3 presents differences between the experimental and the control group on the dependent variables (Hypothesis I). On all variables, except on the experience scale (EG), the experimental group seems to score more positively than the control group, but only for state anxiety and for Anxiety-VAS before the gastro endoscopy this difference turns out to be significant. When these analyses are repeated, but now controlling for the tendency for higher trait anxiety in the control group, results are in the same direction, but now reach significance for state anxiety only (F = 3.02, d.f. = 1, P = 0.04). Most dependent variables are moderately to highly moderately intercorrelated as can be seen in Table 4. Particularly, this concerns the intercorrelation between both anxiety measures before the gastro endoscopy. This is a positive indication for the validity of the Anxiety-VAS. It also concerns both dependent measures after the gastro endoscopy. The worrying variable remains solidly in the middle. Hypothesis I also pertains to the questions about satisfaction with the preparation: one question being asked just before the gastro endoscopy, the other questions just after it. As can be seen in Table 5, the experimental group scores more positively than the control group on four of the five questions asked, whereas for the question about the course of the endoscopy being as expected, there is a tendency in the predicted direction. 4.3. The moderating effect of coping style We first show correlations of monitoring and blunting with other variables (Table 6). Some significant, but modest correlations were found. The modest negative correlation between monitoring and age has been reported in other studies (e.g. [28]; but see [30] for a contrary result), as is the case for the modest positive relation with trait anxiety [17,29,31–33]. Furthermore, it can be seen that monitoring goes hand in hand with worrying about the endoscopy, anxiety during the endoscopy, and the reporting, afterwards, of a negative experience. The only significant correlation for blunting is with not asking for sedation. In accordance with the theoretical basis of the TMSI [28], monitoring and blunting are found to be uncorrelated to each other (r = 0.04), as is the case in other studies using the TMSI [28,29,33]. Hypothesis II concerns the moderating effect of monitoring and blunting on the relation between the independent variable and the dependent variables. For three dependent variables a main effect of monitoring was found: on the Worrying-VAS before the endoscopy (F = 4.65, d.f. = 1, P = 0.03), on the Anxiety-VAS after the endoscopy (F = 5.04, d.f. = 1, P = 0.03) and on the EG (F = 4.24, d.f. = 1, P = 0.04) with high monitors having more worries and anxiety, and a

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Table 2 Group statistics for control and moderator variables Experimental group (n = 47)

Control group (n = 48)

Statistic

d.f.

n = 19 n = 28

n = 13 n = 35

x2 = 1.89

1

0.17

Mean = 49.4 S.D. = 17.2

Mean = 48.8 S.D. = 16.7

t=

0.18

93

0.86

n = 12 n = 16 n = 19

n = 16 n = 18 n = 14

x2 = 1.44

2

0.49

Mean = 39.1 S.D. = 12.2

Mean = 43.3 S.D. = 10.4

t = 1.77

87

0.08

n = 21 n = 25

n = 27 n = 19

x2 = 1.57

1

0.21

Hospitalized/ambulant

n=4 n = 43

n=2 n = 46

Fisher’s exact Test

Monitoring

Mean = 32.8 S.D. = 8.8

Mean = 36.5 S.D. = 10.9

t = 1.76

n = 25 n = 20

n = 27 n = 16

x2 = 0.48

Mean = 37.6 S.D. = 7.1

Mean = 38.5 S.D. = 6.4

t = 0.64

n = 30 n = 15

n = 30 n = 13

x2 = 0.10

Sex Men Women Age Educat. level L M H Trait anxiety IV-Sedation Yes No

Monitoring H L Blunting Blunting H L

more negative experience of the gastro endoscopy, than low monitors. The interaction between monitoring and group (experimental versus control) tends to be significant for Anxiety-VAS after the endoscopy only (F = 2.27, d.f. = 1, P = 0.14), with high monitors in the control group tending to

Table 3 Differences between the experimental and the control group on dependent variables Experimental Control Statistic: P group group t or U one-sided State anxiety before GSa

Mean 44.75 S.D. 11.93

51.04 12.83

t = 2.31

0.01*

Anxiety-VAS before GS

Mean 30.54 S.D. 26.47

41.85 31.35

t = 1.88

0.03*

Worrying-VAS before GS

Mean 59.49 S.D. 28.70

61.74 24.54

t = 0.41

0.35

Anxiety-VAS Mean 22.60 after GS, retro S.D. 19.83

27.35 25.59

U = 902

0.29

EG (after GS)

51.54 7.62

U = 930

0.31

a *

Mean 50.72 S.D. 7.80

Gastrointestinal endoscopy. Significant for a < 0.05, one-tailed.

P two-sided

0.33 86

0.08

1

0.49

86

0.52

1

0.82

experience the highest anxiety. This direction is in accordance with the prediction. For the less reliably measured blunting variable still a main effect appears on state anxiety (F = 5.77, d.f. = 1, P = 0.02) with low blunters experiencing high anxiety. More interestingly, a significant interaction was found for the Anxiety-VAS before the endoscopy (F = 5.71, d.f. = 1, P = 0.02), with, as predicted, low blunters in the experimental group benefiting substantially from the information brochure when compared to high blunters (see Fig. 1). Furthermore, a tendency for an interaction on state anxiety was found with low blunters in the control group experiencing extra state anxiety (F = 3.37, d.f. = 1,

Table 4 Pearson intercorrelations between dependent variables 1. 2. 3. 4. 5.

State anxiety Anxiety-VAS before Worrying-VAS before Anxiety-VAS after, retro Experience gastroscopy *

**

P < 0.05, two-tailed. P < 0.01, two-tailed.

1 0.70** 0.41** 0.28* 0.17

2 – 0.41** 0.56** 0.31**

3

4

5

– 0.23* 0.09

– 0.67**

–

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Table 5 Differences between the experimental and the control group on the questions about satisfaction with preparation for the gastrointestinal endoscopy Question a

Sufficiently prepared? Sufficient imagining? Sufficiently prepared? Course as expected? Satisfaction with quantity of information? a

x2

d.f.

P (one-sided)

Most positive group

32.24 24.09 14.42 7.10 6.67

2 2 2 4 1

<0.01 <0.01 <0.01 0.07 0.01

Experimental Experimental Experimental Experimental Experimental

group group group group group

This was the only question asked just before the gastrointestinal endoscopy.

Table 6 Pearson correlations between the coping styles monitoring (Mon) and blunting (Blun) and other variables Sex Mon Blun a b c * **

0.10 0.04

Age 0.23* 0.06

Education

Trait anxiety

0.21 0.09

0.22* 0.16

IV-sedation

State anxiety

0.08 0.23*

0.07 0.22

A-VAS beforea 0.20 0.03

W-VAS beforeb 0.34** 0.13

A-VAS duringa 0.35** 0.08

EG c 0.27* 0.14

Anxiety-VAS. Worrying-VAS. Experience gastroscopy scale. P < 0.05, two-tailed. P < 0.01, two-tailed.

P = 0.07), and the same type of interaction was obtained for the Worrying-VAS (F = 1.69, d.f. = 1, P = 0.20). 4.4. Use of information brochure In order to assess the actual use of the information brochure, the experimental group were asked to fill in several questions. It turned out that almost all patients (96%) read the whole brochure and not one patient reported to have read its framed summary only. This result implies that the brochure is fully welcome, for low monitors as well as for high monitors. Most subjects read the information brochure once (62%), and a substantial part read it twice (25%). One subject reported to have read the brochure five times. With regard to ‘number of times read’, no relation with monitoring was found, but there

was a tendency that low blunters read the brochure more often than high blunters did (Fisher’s exact P = 0.08). This latter result is in support of Hypothesis III. Of all experimental subjects, 83% reported that the information brochure helped them a great deal to very much. The benefits of the brochure were especially experienced in the period before the gastro endoscopy (74% of the subjects), as compared to 26% who felt its help most during the endoscopy. Almost all subjects (94%) indicated that the best moment to receive the brochure is before coming to the gastroenterology department for undergoing the endoscopy. After the gastro endoscopy, the control group were asked whether they would like to have had written information beforehand. Half of this group (49%) answered they would. Remarkably, more high blunters as compared to low blunters in this control group would like to have had written information (Fisher’s exact P = 0.02). For high monitors as compared to low monitors there was a tendency in their greater wish for written information (Fisher’s exact P = 0.13).

5. Discussion and conclusion 5.1. Discussion

Fig. 1. Interaction between blunting and group on anxiety felt before gastroscopy.

The results are in support of Hypothesis I with regard to the anxiety reducing and satisfaction aspects of the information brochure, although the anxiety reducing aspect gets somewhat deflated with an extra control for trait anxiety. Particularly in the period just before the endoscopy we found a beneficial effect of the brochure, and this is in agreement with what the patients stated afterwards, i.e. that the brochure helped them most in the period before the gastrointestinal endoscopy. But, as we noted in Section 1,

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low anxiety during the gastroscopy is important for a smooth course of the medical procedure. We did not obtain a significant result here, partly, maybe, because of large standard deviations. But also there could be some doubt about the validity of the ‘Anxiety-VAS after’ that retrospectively asked about anxiety during the gastroscopy. Inspection of Table 3 learns that, for both groups, anxiety levels for this Anxiety-VAS are much lower than those measured by the ‘Anxiety-VAS before’. This may imply that possible relief, felt when the examination was over, resulted in an underestimation of the anxiety experienced during the procedure, obscuring possible group differences. Hypothesis II received partial support: for blunting a moderating effect was found on the relation between the information brochure and (VAS)-anxiety before the gastrointestinal endoscopy, with low blunters in the control group experiencing most anxiety. The same type of effect was found for state anxiety and worrying, but now as tendencies. These effects might have been stronger with a more internal consistent blunting scale. For monitoring, there was a tendency to moderate the effect of the information brochure on anxiety during the gastroscopy, in the predicted direction. Also for Hypothesis III there is partial support: low blunters made more frequently use of the information brochure than high blunters. Taking all the data concerning the monitoring–blunting model together, the following picture arises. In agreement with their characterization in the literature [16,17,19,34], for the total group, high monitors were found to have more worries and anxiety, and a more negative experience of the gastrointestinal endoscopy than low monitors. In the experimental group reading the brochure lead to a greater reduction in anxiety in high monitors than in low monitors, and high monitors in the control group showed a greater wish for written information than low monitors (tendency). In the total group, low blunters as compared to high blunters were found to experience higher anxiety before the gastroscopy and more often asked for sedation. The low blunters in the experimental group read the information brochure more often than the high blunters (tendency) and showed a significant greater reduction in anxiety before the endoscopy than high blunters. The same type of effect was found for state anxiety and worrying, but now as tendencies. These effects might have been stronger with a more internal consistent blunting scale and are all in agreement with the theoretical model. Furthermore, there is no sign that, for high blunters, reading the whole brochure was countereffective. Interestingly, it is the high blunters in the control group who, more than the low blunters, would like to have had written information beforehand. An interpretation of this finding might be that, congruent with their coping style, high blunters do not prepare themselves for the medical examination in time and only afterwards realize this, resulting in a wish for timely written information. Promising for future research is a clearer focus on the time aspects of the monitoring and blunting coping styles.

5.2. Methodological limitations For reasons of comparability we made use of the medians of a large study with patients undergoing gastrointestinal endoscopy, for distinguishing between high and low monitors and between high and low blunters [25]. This decision implies that the ‘high’ and ‘low’ categories are no longer evenly distributed among cells with the result that cells with a rather small N may emerge. This was particularly the case when cells had to be split up further for different nominal categories, as for instance in the answers to the separate written questions about satisfaction with the information brochure. The resulting small N’s were also the reason that we had to give up our original plan to explore group differences for four coping style groups as distinguished by Krohne: high monitors-high blunters; high monitors-low blunters; low monitors-high blunters; low monitors-low blunters [35]. Another obstacle in testing hypotheses was that the answer categories of some nominal variables turned out to elicit indiscriminative responses. An example is the variable: ‘did you read the brochure?’ with the answer categories ‘yes, all of it’; ‘yes, framed text only’; ‘only looked at it’; ‘not at all’. All subjects, except one, ticked the first alternative, which made further testing on group differences according to coping style impossible. A final methodological point concerns our decision to control, in an additional analysis, for trait anxiety where, strictly speaking, this was not required because the experimental and the control group did not differ significantly on this variable. This additional analysis yielded less pronounced results. This finding implies that many other outcome studies might show deflated results after controlling for only a tendency in initial group differences on a control variable. 5.3. Conclusion We conclude that providing patients timely with a brochure based on self-regulation theory and including a separate section with summarized information constitutes an efficient, moderately beneficial intervention for undergoing a gastrointestinal endoscopy for the first time. Furthermore, it turned out that the brochure could easily be implemented in a hospital setting without the necessity to take the patient’s monitoring or blunting coping style into account. 5.4. Practice implications The intervention we developed for undergoing a gastrointestinal endoscopy seems promising because of its moderately beneficial effects in relation to its low costs and its time saving aspects. Its cost-effectiveness might be a topic of further investigation. Also there is the fact that the information brochure was fully welcome, given the reported patient satisfaction and the fact that 96% of the patients read the brochure. No adverse effects for high blunters were found, implying that it can be handed out safely to all

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patients irrespective of their coping style. There was no evidence that the separate framed summary, particularly meant for high blunters, was really necessary, although it seems handy to keep it. The brochure—which should be provided to the patient at least 1 day before the actual endoscopies-proved particularly useful in the period before the gastroscopy and constitutes a welcome addition to the role of the coaching nurse. This Dutch information brochure can be used in Belgium and in The Netherlands, but may have to be fine-tuned to the hospital regime involved. Indeed, according to selfregulation theory, congruence between expectations and experience is vital for the information to have a beneficial effect. We do not propose to translate the brochure directly into another language because of different local circumstances and treatment regimes. We rather suggest that it makes sense to develop such a brochure along the same lines and on the same theoretical principles as we reported in the beginning of this article.

[11] [12]

[13]

[14]

[15]

[16]

[17]

[18]

Acknowledgements We thank the Department Gastroenterology from the General Hospital St.-Lucas, Gent, Belgium (Dr. A. Mast, Dr. V. van Maele and Dr. W. Pauwels) and the nurses involved in the study for their hospitality and cooperation.

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