Clown intervention to reduce preoperative anxiety in children and parents: A randomized controlled trial

Abstract

This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children’s preoperative anxiety: children benefited from the clown’s presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety.

Keywords

children’s preoperative anxiety clown intervention complementary and alternative medicine humor parental anxiety

Introduction

Surgery and hospitalization have always been considered negative experiences that can have marked health effects on adults and young children (Karanci and Dirik, 2003; Li, 2007). In particular, a very distressful moment for the hospitalized child is represented by the preoperative period, when specific symptoms such as nervousness, tension, worry, and fear are very common (Kain et al., 2004, 2009; McCann and Kain, 2001).

Even minor surgery can negatively impact on the emotional, behavioral, and cognitive development of a child (Caldas et al., 2004; Li, 2007). Surgical pediatric patients are surrounded by stressful events, and they possess limited cognitive capacities, lack of self-control, greater dependence on others, and limited life experience and knowledge of the health-care system (Li, 2007; Yip et al., 2009). Separation from parents and the home environment, fear of the unknown, loss of control, unfamiliar faces, fear of pain, as well as unfamiliar routines, surgical instruments, and hospital procedures are all possible sources of stress. These contribute to a child’s anxiety level before and after surgery (Brewer et al., 2006; Kain et al., 2004, 2009; Li, 2007). Parental anxiety is also very common during the child’s hospitalization due to the perception of the child’s pain and personal worries and fears, especially when he or she has to undergo surgery (Chahal et al., 2009; Kain et al., 2009; Lamontagne et al., 2003; Wray et al., 2011). For this reason, parental presence during anesthetic induction is somewhat controversial. The presence of parents during medical procedures has showed numerous benefits such as the elimination of separation anxiety and an increase in child cooperation (Kain et al., 2009; Li, 2007; McCann and Kain, 2001).

On the other hand, those who object to parental presence state the possibility of heightened anxiety caused by parents (Kain and Caldwell-Andrews, 2005; Kain et al., 1998) and an increased staff workload in caring for the parent as well as the child (Wright et al., 2007). A review of the research conducted in the perioperative arena shows that most has focused primarily on mothers, probably because they are viewed as the primary caretakers (Yip et al., 2009).

In children, preoperative distress may be associated with postoperative agitation and negative behaviors (Stargatt et al., 2006). Stressful events can have adverse effects on mental and physical health, producing negative outcomes such as emotional disturbance, cognitive inefficacy, and behavioral impairments (Kain et al., 2009). Postoperative maladaptive behavior, such as new onset enuresis, feeding difficulties, apathy, withdrawal, and sleep disturbances, may also result from anxiety before surgery (Kain et al., 2004, 2009). However, these kinds of negative outcomes of stress are not inevitable.

There is a wide range of evidence that prove the effectiveness of both pharmacological (e.g. sedative) and nonpharmacological (e.g. parental presence and complementary alternative medicines) methods to reduce the incidence of preoperative anxiety and relieve children’s pain (He et al., 2010; Kessler et al., 2006; Pölkki et al., 2008; Wright et al., 2007). Over the last three decades, the use of complementary and alternative nonpharmacological approaches has increased considerably in pediatrics as well as in the adult population (Adams and Jewell, 2007). Parents of hospitalized children express a keen interest in providing these practices for their children during hospitalization: it was recently estimated that 11.8 percent of children in the United States use complementary and alternative medicine (CAM) (Barnes et al., 2008). Art therapy, music therapy, pet therapy, and clown therapy are just some examples of the most used nonpharmacological approaches.

In particular, linked to the assumption that humor is associated with the well-being of patients (Bennett and Lengacher, 2008; McGhee, 2010), professional clown doctors began working in hospitals in 1986 under a program called the Big Apple Circus Clown, founded by Michael Christensen, and there has been an increase in performances provided by “clown doctors” in pediatric settings (Dionigi et al., 2012). Clowns, in their interaction with children and parents, use play, spontaneity, lightheartedness, humor, and creativity to relieve the stress of hospitalization and to provide sick children another avenue for emotional expression, control, and social interaction during their hospitalization because the main goal is to change the emotional state of patients and the environment they are in (Koller and Gryski, 2008; Warren, 2008). Clown doctors accomplish this goal using theatre expression techniques that bring their performance to a “climax” and make sure they leave a positive feeling behind. They must be aware of the psychological outcome of their actions and what the patient and their relative environment really need (Dionigi et al., 2012). The few existing studies concerning clown intervention suggest a decrease in the child’s distress and an increase in children’s cooperation with medical procedures (Bertini et al., 2010; Fernandes and Arriaga, 2010, Hansen et al., 2011; Vagnoli et al., 2005, 2007).

The majority of studies have been conducted with professional clowns who were given the opportunity to enter the operating room (e.g. Golan et al., 2007; Vagnoli et al., 2005, 2007). But it is not always possible for clown doctors to enter the operating room.

Vagnoli et al. (2005) conducted a randomized controlled study investigating the effects of the presence of clowns on a child’s preoperative anxiety during the induction of anesthesia and on the parents who accompanied the child. Results showed that the “clown group” (CG) was significantly less anxious compared to the comparison group (CoG).

In another randomized controlled study on 70 children, the group of children accompanied by parents and two clowns showed a lower level of preoperative worries and emotional responses both in children and in parents (Fernandes and Arriaga, 2010). Children in the CG felt less worried about hospitalization, medical procedures, illness, and its negative consequences than those in the CoG. The parents of children in the CG reported lower state anxiety than parents in the CoG. The results emphasized the relevance of clown intervention on the reduction of preoperative worries and emotional responses, not only in children but also in their parents.

Results of a quasi-experimental study indicated that children accompanied by a clown pediatric anogenital examination felt lower pain and less fear (Tener et al., 2011). Furthermore, previous studies measured the role of clown intervention in decreasing parents’ anxiety without using a pretest–posttest design (e.g. Fernandes and Arriaga, 2010; Vagnoli et al., 2005). Although several researches assessed the effectiveness of clown’s intervention in decreasing anxiety, distress, and anger, further studies are necessary to produce stronger evidence of the positive effects of clowns in medical setting (Dionigi et al., 2012).

The purpose of this research was to replicate a similar study conducted in 2005 (Vagnoli et al., 2005). In the present study, some different procedures were adopted. First of all, a larger sample was used. Second, children’s anxiety was not measured in the operating room, but in the preoperating room, before the children had received premedication. Finally, anxiety in parents was evaluated with a pretest–posttest design.

Aim of the study

The purpose of this study was to obtain greater knowledge on the effectiveness of clown therapy as an alternative intervention to reduce preoperative anxiety both in children who must undergo otolaryngologic surgery and in their parents. In many hospitals, clown doctors accompany children into the operating room, but there is a lack of research regarding the effectiveness of their intervention. In this research, it was decided to replicate the study of Vagnoli et al. (2005) making some changes to the experimental design.

The hypotheses were as follows:

The effect of the clown’s intervention can be replicated in a larger sample of both children and parents.

The intervention of clown doctors is effective even if it ends in the preoperating room.

The clown’s intervention reduces the anxiety of parents.

Method

Participants

This randomized controlled study was conducted with children hospitalized in the Morgagni–Pierantoni hospital located in Forlì, Italy. The study started in November 2009 and ended in May 2010. Children were randomly selected from a population who underwent general anesthesia for otolaryngologic surgery depending on the day the surgery was planned. The study was conducted on this sample because otolaryngologic surgery is one of the more common surgeries children undergo. Children included in the study were between 2 and 12 years old and not showing any fear of clowns. Parents had to be Italian native speakers in order to understand the questionnaire. The sample was included in a randomized controlled trial with parallel design.

The project was approved by the Hospital Board Committee, and consent was obtained from parents before inclusion of their child in the study. Participants were not included if the following criteria were present: (a) children younger than 2 years or older than 12 years, (b) parents did not agree to take part in the study, and (c) parents were not able to understand and answer the questionnaire. A flow diagram of participants is shown in Figure 1.

Figure 1.

CONSORT flow diagram.

Eligible participants consisted of 89 children and 141 parents. Twelve children and 22 parents were excluded from the study because they did not meet the inclusion criteria: 12 children did not meet the age criterion, 20 parents declined to participate, and 2 parents were unable to understand the questionnaire because they were not native Italian speakers. The final sample consisted of 77 children (41 male), aged between 2 and 12 years (median = 6 years). Children were randomly assigned to the CG and CoG in a ratio of 2:1 (two cases for every one control), stratifying on age (half of the sample below and half of the sample over the expected mean age of 6 years). For sample size calculation, we assumed an effect size of 60 % thus, to achieve 80 percent power at an alpha level equal to 5 percent, we needed at least 24 patients in each group. Given that we would use a “2 case:1 control” matching, we needed at least 24 patients in the CoG and 48 in the CG.

Fifty-two participants (31 males and 21 females, median age = 6 years, range = 2–12 years) belonged to the CG, who benefited from the intervention of clown doctors. A sample of 25 children (10 males, 15 females, median age = 6 years, range = 2–11 years) belonged to the CoG without the presence of clown doctors. The main characteristics of the sample (i.e. child’s and parent’s age, sex, and nationality) did not differ between groups (all p > 0.05). The study also involved parents who accompanied children to hospital and assisted children during the induction of anesthesia. The sample of parents consisted of 119 people (52 males (44%), median age = 39 years, range = 27–52 years and 67 females (56%), median age = 38 years, range = 24–51 years). The CG consisted of 89 parents (49 women, 55%) and the CoG consisted of 30 adults (18 women, 60%).

Measures

Modified Yale Preoperative Anxiety Scale

The modified Yale Preoperative Anxiety Scale (m-YPAS) (Kain et al., 1995) was used to assess anxiety in children undergoing induction of anesthesia. The m-YPAS consists of 22 items in five domains of behavior indicating anxiety in young children (activity, emotional expressivity, state of arousal, vocalization, and use of parents). The m-YPAS shows domains with good to excellent interobserver and intraobserver reliability (0.73–0.91), and when validated against other global behavioral measures of anxiety, the m-YPAS had good validity (Kain et al., 1995). Higher scores indicate greater anxiety. A trained psychologist rated children’s anxiety both in the waiting room and in the preoperating room.

State–Trait Anxiety Inventory

The State–Trait Anxiety Inventory (STAI) (Spielberger, 1983) is a self-report assessment device that includes separate measures of state and trait anxiety in adults. It consists of two different subscales of 20 items each, which measure both state anxiety (Form X) and trait anxiety (Form Y). State anxiety may fluctuate over time and can vary in intensity. In contrast, trait anxiety refers to a general tendency to respond with anxiety to perceived threats in the environment. Test–retest correlations for the STAI are high (range = 0.73–0.86), and the studies have demonstrated good validity.

The STAI X and Y forms were used to assess the degree of anxiety in parents. They were asked to fill in the questionnaire as soon as they arrived in the hospital and then when they came out from the operating room after their child had received anesthesia.

Parents who took part in the study answered to both subscales, using a Likert scale ranging from 1 to 4. Total scores for each subscales range from 20 to 80, where lower scores indicate a minor level of anxiety.

Interventions

Medical staff was briefed beforehand about the research and presence of clown doctors and psychologist in the ward. They were asked to behave as usual. Parental consent was requested, and all participants were guaranteed anonymity.

Children and parents arrived at the hospital the same day of the surgery in the early morning. Children were randomly assigned to the CG or to the CoG depending on the day of their procedure. In this way, allocation concealment was ensured. As soon as they arrived, the trained psychologist met the parents and asked them to fill in the questionnaire. In the meantime, he filled in the m-YPAS observing children behavior. Only children in the CG received the clown’s intervention. Two clown doctors interacted with a child at a time, for about 30 minutes: in this period of time, the clowns performed various activities, adapting their intervention to the child’s age and to his or her psychological condition. They utilized various methods to entertain the child as gags, soap bubbles, magic tricks, and puppets.

Clown doctors’ purpose was to parody the medical routine using humor in order to help children adjust to the new environment and the intimidating medical jargon and procedures and to defuse states of anxiety. All clown doctors involved had been working in hospitals for not less than 3 years. Regular meetings (once a month) were organized for the whole duration of the research to discuss problems and difficulties that emerged during the work. Furthermore, once a month, the coordinator of the Clown Care Unit was present to supervise the work.

Clown intervention began in the room where the children were hospitalized and ended in the preoperating room. The CoG was composed of children who did not receive the intervention of clown doctors: they were accompanied to the preoperating room by parents and medical staff, with no other distractions.

In both groups, only a parent stayed with the child in the preoperating room (where children received preanesthetic induction), and in most cases, they were with their mothers. All participants underwent the same hospital procedures, and the sequence of scales and questionnaires was identical for both groups.

Parents completed STAI (X/Y forms) as soon as they arrived at the hospital (baseline measure) and during the child’s operation after leaving the preoperating room (test/retest measures). One parent remained with the child in the preoperating room until the child was taken to the operating room. The m-YPAS was completed during the preoperative period by the psychologist who was present during the whole process. Parents were debriefed after the completion of the study.

Statistical analysis

Continuous data are presented as median and range; comparisons between groups were performed using the Mann–Whitney nonparametric test. Categorical variables are presented as frequencies; comparisons between groups were performed using Chi-square test (the Fisher exact test as appropriate). To analyze the time course of the anxiety in each group in relation to baseline values, patients have been stratified according to CG or CoG and analyzed trends in time using analysis of covariance (ANCOVA). To explore correlations between all possible combinations of anxiety levels of children and parents at each point in time, a Spearman test was performed.

Statistical analyses were performed using STATA/SE 11 for Windows (StataCorp LP, College Station, TX, USA). The values of p < 0.05 were considered statistically significant.

Results

Seventy-seven children took part in this study. The demographic characteristics of patients in the CG (n = 52) and CoG (n = 25) are summarized in Table 1. No significant differences were found in any of the demographic characteristics between patients in the two groups. One hundred and nineteen parents were involved in this study.

Table 1.

Demographic characteristic of the study sample.

	Clown group	Comparison group	p
N	52	25
Age, child (median (minimum to maximum))	5.7 (2.1–12.5)	6.0 (2.6–10.7)	0.349^a
Sex, male (n (%))	31 (60)	10 (40)	0.106^b
Age, mother (median (minimum to maximum))	36.9 (24.7–47.6)	40.4 (24.4–51.1)	0.271^a
Age, father (median (minimum to maximum))	39.2 (27.4–52.0)	39.0 (32.2–48.2)	0.731^a
Mother, responders (n, %)	49	18	0.011^b
Father, responders (n, %)	40	12	0.018^b

Mann–Whitney U test.

Fisher exact test.

The primary end point was about the anxiety of the children assessed by the m-YPAS. The analysis of the data indicates that the children in the CoG were less anxious compared to the CG when in the waiting room (p = 0.004). Anxiety in parents showed no significantly differences in the waiting room between CoG and CG (see Table 2).

Table 2.

ANCOVA analysis.

	Clown group	Comparison group	p
Children’s anxiety pre	50 (23–97)	33 (23–97)	Pre-post = 0. 002*; group = 0. 004***
Children’s anxiety post	33 (23–83)	43 (23–100)
Mothers’ state anxiety pre	50 (25–79)	42 (33–58)	Pre-post = 0.035*; group = 0.193
Mothers’ state anxiety post	49 (24–79)	55 (30–65)
Mothers’ trait anxiety pre	38 (25–56)	37.5 (29–48)	Pre-post = 0.001***; group = 0.261
Mothers’ trait anxiety post	38 (16–58)	37 (6–48)
Fathers’ state anxiety pre	36.5 (26–72)	36 (29–56)	Pre-post = 0.005**; group = 0.896
Fathers’ state anxiety post	43 (25–68)	40.5 (29–62)
Fathers’ trait anxiety pre	33.5 (22–56)	33.5 (22–48)	Pre-post = 0.122; group = 0.364
Fathers’ trait anxiety post	34 (22–55)	36 (21–55)

ANCOVA: analysis of covariance.

Intervention outcome variables (range = minimum to maximum); pre-post: difference between pre and post anxiety due to time course; group: difference between groups.

p < 0.05; **p < 0.01; ***p < 0.001.

A statistically significant difference was observed in anxiety between the children in the CG and CoG (Figure 2). Table 2 shows the results of ANCOVA: the CG showed a statistically significant reduction of anxiety scores between scores in the waiting room and preoperating room (p = 0.004).

Figure 2.

Children’s anxiety: differences between Clown Group (CG) and Comparison Group (CoG).

There was no significant difference between the average score of the STAI X–Y obtained by the parents of the CG and CoG. Results in mothers did not differ significant both in state (p = 0.193) and in trait anxiety (p = 0.261). Similar results were found in fathers: no significant difference appeared both in state (p = 0.896) and in strait anxiety (p = 0.364; see Table 2).

A Pearson correlation matrix to examine the relationship between the variables was also generated. Correlation between age and scores obtained with m-YPAS both in CoG and in CG is negatively significant (r = −0.347). The scores obtained by parents with STAI X/Y in the waiting room and preoperating room are positively and significantly related (all p > 0.6). Correlations between scores in the waiting room and preoperating room are shown in Table 3.

Table 3.

Correlations between level of anxiety in waiting and preoperating room (Spearman test).

	Age	Children’s anxiety pre	Children’s anxiety post	Mothers’ state anxiety pre	Mothers’ state anxiety post	Mothers’ trait anxiety pre	Mothers’ trait anxiety post	Fathers’ state anxiety pre	Fathers’ state anxiety post	Fathers’ trait anxiety pre	Fathers’ trait anxiety post
Age	1
Children’s anxiety pre	−0.347*	1
Children’s anxiety post	−0.209	0.3106	1
Mothers’ state anxiety pre	0.033	−0.264	−0.077	1
Mothers’ state anxiety post	0.013	−0.080	0.042	0.723 *	1
Mothers’ trait anxiety pre	0.285	−0.214	0.005	0.450*	0.393*	1
Mothers’ trait anxiety post	0.226	−0.012	−0.063	0.296	0.317*	0.856 *	1
Fathers’ state anxiety pre	−0.300	−0.003	−0.104	0.220	0.239	0.058	−0.081	1
Fathers’ state anxiety post	0.062	−0.257	−0.085	0.360*	0.360*	0.405*	0.190	0.606 *	1
Fathers’ trait anxiety pre	0.112	−0.302	0.007	0.037	0.113	0.417	0.254	0.291	0.369*	1
Fathers’ trait anxiety post	0.217	−0.28	−0.009	−0.077	−0.053	0.273	0.158	−0.055	0.280	0.677 *	1

Values in italic indicate high correlation (>0.6); pre: anxiety in waiting room; post: anxiety in preoperating room.

p < 0.05.

Discussion

The present randomized controlled trial analyzed the effects of clown doctor intervention on children’s and parents’ preoperative anxiety during hospitalization for otolaryngologic surgery. The findings generally support research predictions about anxiety in children. Children in the CG felt less anxious about hospitalization and surgery procedures; they also felt happier and calmer than those in the CoG in both operating phases as in previous studies (Bertini et al., 2010; Fernandes and Arriaga, 2010; Vagnoli et al., 2005, 2007).

No significant difference was found between the two groups in parental anxiety in the pretest and posttest measurements. The purpose of this study was to replicate the study of Vagnoli et al. (2005) making some changes to the experimental design. The hypotheses were that the effect of the clown intervention can be replicated in a larger sample of both children and parents, that the intervention of clown doctors is effective even if it ends in the preoperating room, and that the clown intervention reduces the parental anxiety.

Results lend support to previous findings concerning decrease in anxiety in children who benefited from clowns. The existing studies concerning clown performances suggest decreased levels of distress in the child and parents and increased cooperation of children who undergo medical procedures (Fernandes and Arriaga, 2010; Golan et al., 2007; Vagnoli et al., 2005, 2007).

In this study, the Children’s CG was significantly less anxious compared to the CoG. After clown’s intervention, children in the CG were calmer and less anxious than the children in the CoG, showing that clowning in hospital can be an effective tool to reduce children’s distress. In the CoG, there was an increased level of anxiety in the preanesthesia induction room (preoperating room) in comparison to the waiting room. The findings support researchers’ prediction about the relationship between children’s anxiety and clowns’ intervention: children in the CG showed lower levels of anxiety.

These results support previous research that a clown doctor’s presence reduces the distress of the child preoperatively (Fernandes and Arriaga, 2010; Golan et al., 2007; Vagnoli et al., 2005, 2007). Data showed that children in the CoG were less anxious, in the baseline measure, compared to the CG. This difference was unintended and only due to chance.

Moreover, it was found that the older the child, the less anxious he or she was on arrival at the hospital. This negative correlation can be explained by a higher ability expressed by older children to deal with unusual and unfamiliar settings such as hospitals and frightening situation like a surgery (Li, 2007; Wright et al., 2007).

This study comparing the level in anxiety in the preoperating room was conducted for a specific reason. In previous studies (Vagnoli et al., 2005, 2007), clowns were present in the operating room, during the induction of anesthesia to children.

This procedure is difficult to perform due to the impossibility of clowns to enter into the operating room in the majority of hospitals. The forbidden access is due to the fact that even if the majority of medical staff recognizes the effectiveness of clown intervention for children, they believe that this practice interferes with the routine of the preoperative room, delays procedures, and interferes in the relationship between the medical staff and the child (Vagnoli et al., 2005).

Results support researcher’s predictions. Clown doctors were found to be effective during induction of anesthesia not only in the operating room (Golan et al., 2007; Smerling et al,. 1999; Vagnoli et al., 2005, 2007) but also in the preoperating room. This study demonstrated that clown intervention is effective in decreasing children anxiety, even if limited to the preoperative room. In this way, clown doctors did not interfere with medical staff work in the operating room. According to these results, health-care professionals tend to deem clown intervention as being positive limited to the ambulatory room (Fernandes and Arriaga, 2010).

The third hypothesis was that clown intervention reduces parental anxiety. Results differ from research predictions: no significant difference between anxiety scores in parental groups was found. In previous studies (Fernandes and Arriaga, 2010; Vagnoli et al., 2005), anxiety in parents was assessed only after the clowns’ interventions and compared between CG and CoG. In this study, a pretest–posttest measure was chosen to evaluate differences between the two groups.

It can be hypothesized that the lack of significant difference is due to the fact that clowns were more focused on children. However, the mean score of anxiety in mothers of the CG showed no significant differences between the waiting and induction rooms. On the other hand, anxiety of mothers in the CoG increased. It can be assumed that mothers who enjoyed clown intervention had a calming effect that helped them to keep their anxiety level under control. Mothers were the parent who stayed more with the child during hospitalization and who accompanied him or her to the operating room, spending time together in the preoperating room.

In conclusion, we found that the presence of clowns during the hospitalization of the children and in the time spent before surgery was an effective way to manage child anxiety during the preoperative period. An important result was that clowns were effective in reducing children’s preoperative anxiety in the preoperating room, before receiving premedication. In this way, anxiety in children was decreased without interfering with the medical staff’s work.

Limitations need to be addressed. One limit of this research is not having investigated deeply into the relationship between parents and children. Children who were accompanied by more anxious parents scored higher in preoperative anxiety. Due to the lack of variables tested, we cannot assess the relationship. This result supports the conclusions of a Cochrane review, where it appears that the presence of parents during induction of general anesthesia does not reduce children’s anxiety (Yip et al., 2009). Furthermore, this finding is consistent with the study of Fernandes and Arriaga (2010) that discovered that the child’s emotionality and parental state anxiety associations are not strong enough to predict child worries when considering the relevance of clown intervention.

Another limit of the study is the large span of children involved in the study. Children of different ages, in fact, may have different reactions to surgery and different ways of interacting with parents.

Overall, the findings of the present study suggest that clown intervention helped in the reduction in children’s anxiety, but not in parental anxiety. Research into clown “therapy” is in its infancy, and only few studies have been conducted to study the effectiveness of clown therapy in decreasing preoperative anxiety. For this reason, further investigations are required.

Footnotes

Acknowledgements

The authors acknowledge the staff of Morgagni–Pierantoni Hospital in Forlì, Italy, and particularly the Head Physician Dr Claudio Vicini and all the nurses for their kind collaboration. Thanks to Manuela Magnani for her assistance. A very warm thank you to all the clown doctors of the Clown Care Unit “I nasi rossi del dottor Jumba” of Cesena (FC), Italy, for their help in the study and for their kind collaboration.

Funding

This study was supported by Program Project Grant PG 2011- 0127533 from the Social Services Department of Emilia Romagna Region (Italy).

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