This study conducted a systematic review and meta-analysis of randomized controlled trials on the use of therapeutic clowns in pediatrics. It found 19 eligible studies and included 16 in the meta-analysis. The main findings were: 1) Clown therapy significantly reduced anxiety in children based on a pooled standardized mean difference of -0.83 favoring clown therapy. 2) Clown therapy significantly reduced state anxiety in parents based on a pooled standardized mean difference of -0.46 favoring clown therapy. 3) Clown therapy did not significantly reduce pain levels in children or the need for anxiolytic drugs.

1. ORIGINAL ARTICLE
Therapeutic clowns in pediatrics: a systematic review
and meta-analysis of randomized controlled trials
Kannan Sridharan1
& Gowri Sivaramakrishnan2
Received: 29 June 2016 /Revised: 1 August 2016 /Accepted: 19 August 2016
# Springer-Verlag Berlin Heidelberg 2016
Abstract Children and/or their parents are in fear and anxiety
when admitted to hospitals or undergo invasive surgeries or
investigations. Clown therapy has been shown as an effective
measure in reducing this hospital fear and anxiety. Hence, we
carried out a systematic compilation of the existing evidence
on the clinical utility of hospital clowns in pediatric popula-
tion. Electronic databases were searched with an appropriate
search strategy, and only randomized controlled trials compar-
ing the effect of clown therapy with standard care in children
were included. The key outcome measures were as follows:
extent of anxiety and pain felt by children and extent of state
and trait parental anxiety. Random effect model was applied
when moderate to severe heterogeneity was observed. Forest
plot, I2
statistics and risk of bias were evaluated using
RevMan 5.3 software. A total of 19 studies were found eligi-
ble to be included in the systematic review and 16 for meta-
analysis. The pooled SMD [95 % CI] for child anxiety score
was −0.83 [−1.16, −0.51] favoring clown therapy. Similarly, a
statistically significant reduction {SMD [95 % CI] −0.46
[−0.7, −0.21]} in the state anxiety was observed amongst
parents.
Conclusion: We found that hospital clowns play a signifi-
cant role in reducing stress and anxiety levels in children ad-
mitted to hospitals as well as their parents.
What is known:
• Trials with clown doctors in pediatric population have shown
conflicting results in allaying anxiety amongst children undergoing
either hospitalization or invasive procedures
What is new:
• This is the first systematic review and meta-analysis on hospital clowns
• We found out that hospital clowns reduce anxiety amongst children
before undergoing either hospitalization or invasive procedures
Keywords Hospital clowns . Medical clowns . Children
Abbreviations
CI Confidence interval
NRS Numerical rating scale
RR Relative risk
SMD Standardized mean difference
VAS Visual analogue scale
Introduction
Children admitted to pediatric wards or intensive care units are
stressed due to separation from their parents, the strange en-
vironment, and fear of painful procedures/treatment [47]. A
prevalence of 83.3 % pre-operative anxiety was observed
amongst children during their stay in operative room [12].
Adverse psychological and behavioral changes such as
Revisions received: 29 June 2016; 2 August 2016
Communicated by Jaan Toelen
Electronic supplementary material The online version of this article
(doi:10.1007/s00431-016-2764-0) contains supplementary material,
which is available to authorized users.
* Kannan Sridharan
skannandr@gmail.com
Gowri Sivaramakrishnan
gowri.sivaramakrishnan@gmail.com
1
Department of Health Sciences, College of Medicine, Nursing and
Health Sciences, Fiji National University, Suva, Fiji
2
Department of Oral Health, College of Medicine, Nursing and Health
Sciences, Fiji National University, Suva, Fiji
Eur J Pediatr
DOI 10.1007/s00431-016-2764-0

2. decrease in children’s self-esteem and emotional well-
being, increased anxiety, sleep disturbances, and social
isolation have been observed not only during hospital
stay but also in 25 % of children, 1-year post-discharge
from pediatric intensive care unit [11, 37]. A recent
systematic review on the same topic identified negative
psychological sequelae amongst children [38]. Not only
in children but also parents face similar stress and anx-
iety in these situations. High parental anxiety could be
observed if their child is admitted in intensive care unit,
where nearly 62 % had anxiety that was significantly
higher than a validated sample of patients with general-
ized anxiety disorder [33].
Clowns in the hospitals, otherwise called as clown
doctors, interact with the pediatric patients and/or their
parents to reduce their apprehension, fear and blues,
thereby ease their recovery [26]. Clown doctors have
been shown to be very good at distraction therapy from
pain-inducing source, especially in children [2].
Theatrical intervention and humor in the treatment of
patients have been documented as early as thirteenth
century [18]. It has also been scientifically proven that
hearing jokes from medical clowns was associated with
increased activity in the network of subcortical regions,
including the amygdala, the ventral striatum, and the
midbrain, which are involved in experiencing positive
reward [5]. Considering the lacunae of a systematic re-
view on this topic, we carried out the present study
with an objective of systematically compiling the
existing evidence regarding the utility of medical
clowns in various pediatric conditions and applying the
principles of meta-analysis on the eligible outcome
measures.
Methods
Information sources and search strategy
The protocol for this review was registered with international
prospective register of systematic reviews (PROSPERO) with
the registration number CRD42016041248. The review pro-
tocol can be accessed at http://www.crd.york.ac.
uk/PROSPERO/display_record.asp?ID=CRD42016041248.
A thorough literature search was conducted and was
completed on 14 June 2016. The primary data base used
was Medline (via PubMed), Cochrane central register of
clinical trials, Database of Abstracts of Reviews of Effects
and Google Scholar. The key words used were clown [tiab].
This search was further supplemented by hand searching of
relevant references from review articles and other eligible
studies. No limits were applied in the present review.
Eligibility criteria
Only those studies with randomized controlled design with the
following requirements were included in the present study:
1. Type of participants—children who were either admitted
in the hospital or underwent any invasive procedures such
as intravenous cannulation or blood collection or minor
surgeries under anesthesia
2. Type of intervention—hospital clown
3. Comparison—usual standard of care without clown
intervention
4. Outcome—The primary outcome measures were the
number of children with anxiety, the extent of anxiety
measured by any scale and the extent of pain felt as mea-
sured by any scale. The secondary outcome measures
were the number of children who cooperated, extent of
cooperation measured by any scale, number of caregivers
with anxiety, extent of anxiety felt by the caregivers, time
taken for inducing anesthesia, number of children shifted
from the planned inhalational to intravenous anesthesia,
number of children requiring an increased requirement of
anesthesia, number of children satisfied with the care pro-
vided, number of parents satisfied with the care provided,
number of times anxiolytic drugs were used and number
of attending interruptions by the hospital staff.
Study procedure
Two authors independently screened the data bases and
reviewed the identified abstracts for suitability. Full-text arti-
cles were obtained following abstract screening for those
found to be eligible to be included in the review. A pre-
tested data extraction form was created and two authors inde-
pendently extracted the following data from each eligible
study: trial site, year, trial methods, participants, interventions,
and outcomes. Disagreement between the authors was re-
solved through discussion. The extracted data were analyzed
using non-Cochrane mode in RevMan 5.3 software. The
methodological quality of eligible trials was independently
assessed by both the authors using the Cochrane collabora-
tion’s tool for assessing the risk of bias. We followed the
guidance to assess whether trials took adequate steps to reduce
the risk of bias across six domains: sequence generation, allo-
cation concealment, blinding (of participants, personnel, and
outcome assessors), incomplete outcome data, selective out-
come reporting, and other sources of bias. The judgment was
categorized into low, high or unclear risk of bias [23]. For
continuous outcome measures, standardized mean differences
(SMD) and risk ratio (RR) for categorical outcomes were con-
sidered for the final assessment from individual studies. SMD
was chosen as a measure of pooled results considering the
Eur J Pediatr

3. variability observed in the measuring scales for continuous
outcomes. The SMD was categorized as small, medium, and
large based on the thresholds 0.2, 0.5, and 0.8, respectively, as
suggested by Cohen’s [10]. Ninety-five percent confidence
interval (95 % CI) was used to represent the deviation from
the point estimate for both the individual studies and the
pooled estimate. The heterogeneity between the studies were
assessed using forest plot visually, I2
statistics wherein more
than 30 % was considered to have moderate to severe hetero-
geneity and Chi-square test with a statistical P value of less
than 0.10 to indicate statistical significance. Random effect
models were used in case of moderate to severe heterogeneity
otherwise fixed effect models were generated. Egger’s Funnel
plot was used to assess publication bias for those outcomes
that have at least ten studies. The present meta-analysis was
conducted and presented in accordance with Preferred
Reporting Items for Systematic Reviews and Meta-Analyses
guidelines [31].
Results
Search results
A total of 91 studies were obtained from the electronic
databases of which finally 19 [1, 3, 7, 9, 13, 15–17,
Fig. 1 Study flow chart. A total of 91 studies were obtained with the
search strategy of which 19 were included in the systematic review and 16
in the meta-analysis
Fig. 2 Summary of risk of bias of the included studies. Red circle with
minus symbol indicates the absence of reporting specific element by the
authors while green circle with plus symbol indicates reporting of the
same. Festini et al. 2014 [31] was a conference abstract and none of the
elements of risk of bias could be assessed
Eur J Pediatr

4. 19–22, 25, 29, 30, 41–43, 48] were found eligible to be
included in the present review (Fig. 1). A summary of the
key characteristics of the included studies is mentioned in
Table S1, available as supplementary file. Risk of bias of
the studies included in the systematic review is depicted in
Fig. 2. One of the included studies was a conference ab-
stract [17] and so risk of bias could not be judged. Authors
in the same study had displayed a video of clown doctors to
the experimental group of children and the only outcome
measure reported in this abstract was the anxiety score for
children. Hence, we also carried out a sensitivity analysis
for this outcome by excluding this study to see the impact of
this data. Of the 19 studies, three [9, 21, 25] did not report
the outcome measures appropriately to be included in the
quantitative synthesis. The corresponding authors of these
studies were sent an electronic communication requesting
for the details, but did not respond. Hence, a total of 16
studies were included for the final meta-analysis.
Publication bias could be assessed only for one of the out-
comes—extent of anxiety experienced by children and no
bias was observed (Fig. 3).
Pooled results
Primary outcomes
Extent of anxiety experienced by children A total of 11
studies that included 689 children compared the effect
of clown therapy with the standard of care on the extent
of anxiety felt by study participants. Seven studies used
modified Yale pre-operative anxiety scale (m-YPAS) and
one each had used facial affective scale, Likert scale,
children anxiety, and pain scale—anxiety component
and child surgery worries questionnaire to assess the
same. The pooled SMD [95 % CI] for child anxiety
score was −0.83 [−1.16, −0.51] favoring clown therapy
(Fig. 4). Sensitivity analysis after removing the data
from the conference abstract [17] did not influence the
interpretation of pooled estimate {0.82 [−1.17, −0.47]}.
Extent of pain felt during invasive procedures in children
Five studies compared pain felt during the procedures in a
total of 257 participants. Three studies used visual analogue
scale (VAS) and two employed numerical rating scale (NRS).
Figure 5 depicts the forest plot of changes in the pain score
and no significant difference was observed in the pooled
estimate.
Number of children with anxiety symptoms None of the
included studies reported the number of children with anxiety
symptoms individually in both the groups and hence analysis
of this variable was not performed in the present meta-
analysis.
Secondary outcome measures
Extent of anxiety experienced by parents Eight studies
compared the effect of clown therapy with standard of care
on parental anxiety. Of these, all the eight (in a total of 489
study participants) assessed state anxiety of the parents while
only four (in a total of 217 study participants) assessed trait
Fig. 3 Assessment of publication bias by Egger’s funnel plot.
Publication bias was assessed only for the anxiety score in children and
no bias was detected as evident by the symmetrical distribution of the
effect estimates of individual studies
Fig. 4 Forest plot of anxiety score with clown therapy in comparison to standard of care. A statistically significant reduction in the anxiety score was
observed with the pooled estimate favoring the use of clown therapy
Eur J Pediatr

5. anxiety additionally. A statistically significant reduction in
state anxiety {SMD [95 % CI] −0.46 [−0.7, −0.21], Fig. 6}
was observed with clown therapy in comparison to standard of
care but not in the trait anxiety {SMD [95 % CI] −0.21 [−0.69,
0.28], Fig. 7}.
Number of children requiring the use of anxiolytics Two
studies in a total of 522 children reported the total number of
children requiring the use of anxiolytics. The pooled relative
risk was found to be 0.47 [0.15, 1.53] and was not statistically
significant (Fig. 8).
Other secondary outcome measures None of the eligible
studies included in this review reported number of children
for inhalational but administered intravenous anesthetic agent
due to non-cooperation, or those requiring increased anesthet-
ic agents or children satisfied with the given care. Only one of
the studies reported the time taken for induction of anesthesia,
number of parents satisfied with the given care, number of
interruptions by the healthcare staff and number of parents
with anxiety, thus could not be used for the meta-analysis.
Discussion
We conducted the present study to compare the clinical
utility of hospital clowns in comparison to standard of
care to alleviate fear, anxiety and pain in children, who
were either admitted in pediatric ward or undergoes in-
vasive procedures in the form of intravenous cannula-
tion or minor surgeries under anesthesia. We also stud-
ied the effect of clown therapy on parental anxiety. A
total of 19 eligible studies were obtained. We found that
clown therapy significantly reduces the anxiety experi-
enced by children and state anxiety in parents. The size
of the reduction in anxiety was found to be large with
children and medium with parents in the present study.
We found that medical clowns are therapeutically
useful to alleviate fear and anxious symptoms in admit-
ted children. Good communication between healthcare
staff and children, as well as their parents is an essential
support to be offered, to ease stress in parents whose
child is admitted in pediatric wards [45]. The presence
of medical clowns supplements the support and
strengthens the system. The Hamberg field survey was
a nation-wide survey of clowns, parents and supporting
staff in hospitals in Germany and concluded that clown
intervention boosts morale and reduces stress in patients
without any side effects [4]. The utility of medical
clowns is more stressed when invasive procedures are
being carried out in children such as intra-articular in-
jection of corticosteroid in patients with juvenile idio-
pathic arthritis [34, 44]. Decreased stress and pain with
a positive patient experience was observed when thera-
peutic clowns were offered in addition to nitrous oxide
Fig. 5 Forest plot of pain score with clown therapy in comparison to standard of care. No significant reduction in the pain score was observed with
clown therapy in comparison to standard of care
Fig. 6 Forest plot of state anxiety experienced by parents with clown therapy in comparison to control. A significant reduction in the state anxiety was
observed amongst parents with clown therapy in comparison to standard of care
Eur J Pediatr

6. sedation for such children and their parents [44]. In fact,
Dvory et al. [14] have shown that there was no need for
sedation in children undergoing radionuclide scanning,
when therapeutic clowns were present. Colville et al.
[11] found that 63 % of the children discharged from
pediatric intensive care unit reported at least one factual
memory of their admission and 32 % reported delusion-
al memories, including disturbing hallucinations, thus
having post-traumatic stress disorder. Additionally,
Muscara et al. [32] assessed various psychological reac-
tions amongst parents and found that 49–54 % met the
criteria for acute stress disorder; 15–27 % had clinical
levels of depression and anxiety, and 25–31 % for gen-
eral stress. So, we suggest that clown therapy should
also be offered to parents of children admitted in pedi-
atric ward and future studies should focus on generating
evidence on this aspect. Medical clowns have also been
shown to be effective in inculcating positive attitude in
geriatric patients especially in dementia [28, 35], pa-
tients with psychiatric disorders [46] and those undergo-
ing dialysis [6].
Ventures such as BDream Doctors Project^ in Israel
and BMedical Clown Project^ in the United States of
America have been initiated that consists of individuals
with a background in dramatic arts like acting, street
theater and physical clowning, etc. with appropriate
training to work in hospitals. All hospitals and especial-
ly those offering services to pediatric population, elderly
and palliative care should make arrangements to employ
such trained medical clowns. If such therapy cannot be
offered to all the admitted children due to resource con-
straints, at least it should be offered to those at high
risk of developing negative psychological sequelae,
based on their level of illness severity and the number
of invasive procedures they are exposed to [39].
Additionally, children rehabilitation centers also have
similar stress environment where children suffer from
lengthy separation from their parents and prolonged re-
stricted activities [8]. A pilot study amongst disabled
children observed that a more positive and fewer nega-
tive facial expressions and emotional disturbances dur-
ing the clown intervention [24]. Authorities should also
take efforts in employing hospital clowns to improve
mental stability of residents in such institutions.
Appropriate training of clowns is essential to convert
them to hospital clowns so that they learn the right
approach to babies, children, adolescents, and their par-
ents who will be sensitive given the environment [27].
Medical clown measure is a self-reported questionnaire
to assess the perception of clown’s presence [40]. It is a
validated tool and future studies shall utilize this tool in
addition to other measures to actually assess the impact
of using medical clowns.
Hospital clowning is an interdisciplinary art with a
wide variety of multiple skills such as humor, drama,
music, and dance due to which a beneficial, therapeutic
impact have been noted in patients [36]. To conclude,
we found that hospital clowns play a significant role in
reducing stress and anxiety levels of children admitted
to hospitals as well as their parents.
Fig. 7 Forest plot of trait anxiety amongst parents with clown therapy in comparison to standard of care. No significant difference was observed in trait
anxiety amongst parents with clown therapy in comparison to controls
Fig. 8 Forest plot of relative risk of anxiolytic use between the groups. No significant risk of anxiolytic use was observed with clown therapy in
comparison to control group
Eur J Pediatr

7. Acknowledgments We thank Prospero for registering this review pro-
tocol and Cochrane for utilizing RevMan 5.3 software in generating the
pooled results and forest plot.
Authors’ contribution KS—conceived the idea, analyzed the data,
wrote the first draft of the manuscript, and approved the final draft. KS
and GS—literature search, identified the studies, extracted the data, re-
vised the draft of the manuscript, and approved the final draft of the
manuscript.
Compliance with ethical standards
Funding No fund was obtained for conducting this study.
Conflict of interest The authors declare that they have no conflict of
interest.
Ethical approval This article does not contain any studies with human
participants performed by any of the authors.
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