Journal of Clinical Anesthesia (2016) 36, 27–31

Original contribution

The effect of play distraction on anxiety before

premedication administration: a randomized trial☆
Gözde Bumin Aydın MD (Associate Professor)a , Serhat Yüksel MD b ,
Jülide Ergil MD (Associate Professor)a , Reyhan Polat MD a , Fatma Kavak Akelma MD c,⁎,
Musa Ekici MD d , Murat Sayın MD (Associate Professor)a , Öner Odabaş MD (Professor)d
a
Ministry of Health Dıskapı Research and Training Hospital Anesthesiology and Reanimation Clinic, Ankara, Turkey
b
Ministry of Health Dıskapı Research and Training Hospital, Psychiatry Department
c
Department of Anesthesiology, Ministry of Health, Ankara Zubeyde Hanim Etlik Maternity and Gynecology Research and Training
Hospital, Ankara, Turkey
d
Ministry of Health Dıskapı Research and Training Hospital Urology Clinic, Ankara, Turkey

Received 28 July 2015; revised 22 April 2016; accepted 24 April 2016

Keywords:
Abstract
Premedication anxiety;
Study objective: The majority of children scheduled to undergo surgery experience substantial anxiety
Pediatric anesthesia;
in the preoperative holding area before induction of anesthesia. Pharmacological interventions aimed at
Distraction;
reducing perioperative anxiety are paradoxically a source of stress for children themselves. Midazolam is
Play dough
frequently used as premedication, and the formula of this drug in Turkey is bitter. We aimed to assess the
role of distraction in the form of playing with play dough (Play-Doh) on reducing premedication anxiety
in children.
Design: Prospective randomized clinical trial.
Setting: Preoperative holding area.
Patients: One hundred four healthy children aged 3 to 7 years scheduled to undergo elective surgery were
enrolled into the study.
Interventions: All children routinely receive sedative premedication (oral midazolam) before anesthesia.
Children were randomized to 2 groups to receive either play dough (group PD) (n = 52) or not (group C)
(n = 52) before administration of oral premedication.
Measurements: Children's premedication anxiety was determined by the modified Yale Preoperative
Anxiety Scale (mYPAS).
Main results: The difference in mYPAS scores between groups at T0 (immediately after entering the preop-
erative holding area) was not significant (P = .876). Compared with group C, group PD was associated with
lower mYPAS scores at T1 and T2 (P b .001). In group PD, mYPAS scores were significantly lower at both
T1 and T2 as compared with the scores at T0 (P b .001); they were similar between T1 and T2 (P N .001).
Conclusion: This study showed that distraction in the form of playing with play dough facilitated adminis-
tration of oral midazolam in young children.
© 2016 Published by Elsevier Inc.

☆
Conflict of interest/support: There is no conflict of interest or any financial support.
⁎ Correspondence: Fatma Kavak Akelma, Department of Anesthesiology, Ministry of Health, Ankara Zubeyde Hanim Etlik Maternity and Gynecology Research
and Training Hospital, Aşağı Eğlence Mah. Yeni Etlik Cad., Etlik (İncirli), Keçiören, Ankara 06610, Turkey. Fax: +90 312 5674 208.
E-mail address: fatmakavak@yahoo.com (F.K. Akelma).

http://dx.doi.org/10.1016/j.jclinane.2016.04.044
0952-8180/© 2016 Published by Elsevier Inc.
28
1. Introduction
The majority of children scheduled to undergo surgery ex-
perience substantial anxiety in the preoperative holding area
before induction of anesthesia [1,2]. Potential causes of preop-
erative anxiety are separation from parents, unfamiliar envi-
ronments and people, and negative anticipation of surgical
procedures [1]. Anxiety in the preoperative holding area may
manifest itself by facial expressions of fear, trembling, panic,
crying, or even combativeness. Preoperative anxiety also has
been associated with difficulty in anesthetic induction [2].
Pharmacological interventions aimed at reducing perioper-
ative anxiety are paradoxically a source of stress in children
themselves. Oral administration of such drugs may cause re-
fusal, and insistence may aggravate anxiety [3]. Anxiety, in
turn, may impair cooperation and induce refusal [4]. Taste is
another factor associated with drug compliance [5]. Midazo-
lam is frequently used in premedication [6–8] and routinely
used in our department. However, the oral preparation of this
drug in Turkey is bitter [9]. Premedication with midazolam,
therefore, may not significantly reduce preoperative anxiety
but, instead, may aggravate it in some cases if refused. The
use of distraction in the form of clowns, video games, and
cartoons has been shown to alleviate preoperative anxiety in
children [10–12]. Although some of these interventions are
more frequently used, others are not due to time constraints,
adverse effects, or rising health care costs. Play dough (PD)
is a simple, inexpensive toy enjoyed by the majority of
preschool- and elementary school–aged children.
We performed this randomized, placebo-controlled study
to test the hypothesis that playing with play dough would
reduce premedication anxiety in preschool children undergoing
elective surgery.
2. Methods
The study took place in August and September 2013 in Min-
istry of Health Yildirim Beyazit Diskapi Education and Research
Hospital. Children were prospectively and consecutively enrolled
in the study after their parents provided written informed consent
[13]. The study protocol was approved by the Institutional
Ethics Committee (reference no. 4/65, 24/09/2012) and
was registered in the Australian New Zealand Clinical Trial
Registry prospectively (ACTRN12613000928718).
One-hundred four healthy children aged between ages 3
and 7 years and scheduled to undergo elective urogenital
surgery under general anesthesia were enrolled into the study.
Children with a history of previous anesthesia, chronic
disease, prematurity, and growth retardation and those with
an impaired vision or hearing were excluded. Children
were randomized through sealed envelope method into either
the PD (group PD) (n = 52) or no PD (group C) (n = 52) by
the anesthesiologist. The primary end point of this study was
the anxiety manifested by children at the time of premedica-
tion administration.
G. Bumin Aydın et al.
All operations were scheduled in the morning, and all chil-
dren are accompanied by their parents. An anesthesiologist
assessed all the patients' level of anxiety using the modified
Yale Preoperative Anxiety Scale (mYPAS), immediately after
entering the preoperative holding area (T0). After 3 minutes of
waiting in the preoperative holding area, group PD received
PD and allowed to play with it for 6 minutes. An anesthesiol-
ogist assessed the patients' level of anxiety using mYPAS just
after playing with PD (T1). T2 was assessed during adminis-
trating 0.5 mg/kg oral midazolam 5 minutes after T1.
In group C, children waited for 9 minutes in the preopera-
tive holding area. After this 9 minutes, an anesthesiologist
assessed the patients' level of anxiety using the (mYPAS)
(T1). T2 was assessed during administrating 0.5 mg/kg oral
midazolam 5 minutes after T1. Children in the control group
were rewarded with a PD after surgery.
The level of anxiety in children was assessed in the preop-
erative holding area using the mYPAS [14]. The mYPAS,
which is an observational checklist consisting a total of 22
items in 5 domains: activity, emotional expressivity, state of
arousal, vocalization, and the use of parent, is accepted as a re-
liable tool for assessing children's anxiety during the perioper-
ative period. Total score varies between 22.5 and 100, and
higher scores correlate with greater anxiety [14].
2.1. Statistical analysis
We used the SPSS version 11.5 (SPSS, Inc, Chicago, IL) to
perform statistical analyses. We used the Shapiro-Wilk test to as-
sess the normality of variables. Continuous variables were sum-
marized with median (minimum-maximum) and percentage.
We performed Pearson χ2 test on categorical variables and
Mann-Whitney U test, Friedman test, and Wilcoxon signed
rank test on continuous variables. We also used the repeated-
measures analysis of variance with the SPSS generalized linear
model approach. Statistical significance was set at P ≤ .05.
The sample size of 43 per group was determined by using
28 ± 8 as the mean ± SD values of the mYPAS scores report-
ed for children and by assuming that a reduction of 5 U in the
anxiety score would be significant at .05 (α) for type I and 0.2
(β) for type II error [14,15].
3. Results
In August and September 2013, we enrolled 109 patients
to the study (54 to group PD, 55 to group C) but dismissed
4 patients because of upper airway infection and 1 family
refused the operation in the preoperative holding area so the
study ended with 52 patients in each group (Fig. 1).
Group PD and group C were well matched in relation to age (P =
.876), sex (P = .556), and body weight (P = .926) (Table 1).
The difference in mYPAS scores between groups at T0 was
not significant (P = .876), but group PD has significantly
lower scores at T1 and T2 than group C (P b .001, for both
Distraction facilitates administration of premedication 29

comparisons). Comparison of scores within the both groups among Table 1 Sociodemographic and anthropometric characteristics
the 3 designated time points was significant (P b .001). In the of the groups a,b,c,d
group PD, mYPAS scores at T1 and T2 (P = .103) were simi- Group PD (n = 52) Group C (n = 52) P
lar, but they were both significantly lower than scores at T0 a
Age (y) 5 (3-7) 5 (3-7) .876 b
(P b .001). In the group C, mYPAS scores measured at T2
Sex c .556 d
were significantly higher than T1, which was also significantly
Male 27 (51.9) 24 (46.2)
higher than T0 (P b .001 for both comparisons) (Table 2). Female 25 (48.1) 28 (53.8)
Repeated-measures analysis of variance yielded significant BW (kg) a 18 (9-36) 24 (22.4-26.4) .740 b
results (F(1102) = 29.22; P b .001) and the group-by-time
BW = body weight.
interaction (F(2204) = 153.88; P b .001). Although mYPAS a
Values are expressed as medians (minimum-maximum).
scores in the group PD displayed a time-dependent decrease, they b
Mann-Whitney U test.
c
displayed a time-dependent increase in the group C (Fig. 2). Values are expressed as number (percentages).
d
Pearson χ2 test.

4. Discussion intervention would reduce their anxiety. We assessed anxiety

using the mYPAS, which has previously been shown to be a
In the current study, we let children play with PD before reliable tool to measure anxiety in children [14]. We demon-
premedication with midazolam and examined whether this strated that playing with PD significantly reduced preoperative

CONSORT 2010 Flow Diagram

Enrollment
Assessed for eligibility (n=109)

Excluded (n=4)

Not meeting inclusion criteria (n=4)

Declined to participate (n=1)

Randomized (n=104)

Allocation

Allocated to intervention (n=52) Allocated to intervention (n=52)

Received allocated intervention (n=52) Received allocated intervention (n=52)

Did not receive allocated intervention (give Did not receive allocated intervention (give
reasons) (n=0) reasons) (n=0)

Follow-Up
Lost to follow-up (give reasons) (n=0)
Lost to follow-up (give reasons) (n=0)
Discontinued intervention (give reasons) (n=0)
Discontinued intervention (give reasons) (n=0)

Analysis

Analysed (n=52) Analysed (n=52)

Excluded from analysis (give reasons) (n=0) Excluded from analysis (give reasons) (n=0)

Fig. 1 Consort flow diagram of randomization and study groups.

30 G. Bumin Aydın et al.

Table 2 mYPAS scores of the groups at the time points a, b In our preoperative holding area, we have a toy corner for
Group PD (n = 52) Group C (n = 52) P a the children waiting for surgery. Although they were waiting
accompanied with their parents, we gave them the toy they
T0 29 (24-43) 29 (24-43) 1.000 want to play, but some of the mothers rejected our offer be-
T1 25 (24-35) 30 (25-43) b .001
cause of cleanliness anxieties. As far as we are observed, some
T2 25 (24-43) 31 (26-43) b .001
of the children did not want to play alone with the toys; also,
Pb b .001 b .001
some have emotional bonds with their toys, and they regret
Values are expressed as medians (minimum-maximum).
a to play with newly met ones.
Mann-Whitney U test.
b
Friedman test. The reason we chose PD in the current study was not just
because it is a simple, clean, inexpensive, and familiar toy
enjoyed by the majority of children. It also requires high con-
anxiety and eased midazolam administration in children. centration and creativeness.
Significant increase in mYPAS scores observed in children Limitations related with the use of previously assessed non-
in the group C during midazolam administration clearly dem- pharmacological interventions may be summarized as follows:
onstrated that midazolam administration, itself, is a source of playing with video games in small children may be less effec-
substantial distress in children. tive in relieving preoperative anxiety because it requires a
Several pharmacological and nonpharmacological inter- complex set of hand skills. Furthermore, most children are fa-
ventions including sedative premedication, hypnosis, parental miliar with only a few video games and cannot play others. It
presence, behavioral preparation programs, and music therapy is also difficult and costly to prepare many video game con-
have been previously assessed for their efficiency to prevent or soles in the preoperative holding area [11]. Showing cartoons,
alleviate preoperative anxiety [16]. Kain et al [1] reported that similarly, requires additional equipment. Using a clown to in-
there was an increasing trend toward allowing parental pres- teract with children in the preoperative holding area is the most
ence in the preoperative holding area since 1995. All children demanding intervention as it would either decrease productiv-
in the current study were accompanied by their parents in the ity, in the case of using a voluntary health care provider, or
preoperative holding area. would increase expenditure, in the case of hiring a profession-
The first step toward reducing preoperative anxiety in chil- al. In addition, some children are genuinely scared of clowns.
dren is to distract them by showing cartoons or video games Oral midazolam has been shown to provide effective pre-
and thereby achieving a good cooperation [17]. Although sev- operative sedation in children. Advantages of midazolam over
eral studies demonstrated that interventions such as using other sedative premedications include rapid absorption after
clowns, playing with video games, and watching cartoons alle- oral administration, absence of nausea, ease of administration,
viate preoperative induction anxiety, to the best of our knowl- and a short elimination half-life [18]. Although children usual-
edge, there is only 1 study that showed that such interventions ly prefer oral administration, some may simply refuse to take it
reduced premedication anxiety as well [10,11,12,15]. In that due to its bitter taste or due to mere unwillingness [9]. Our re-
study, children who were given toys in the preoperative hold- sults demonstrated that playing with PD not only significantly
ing area were observed to exhibit less anxiety before midazo- reduced premedication anxiety but also eased oral administra-
lam administration. [15]. tion of midazolam and decreased drug rejection [4].

Fig. 2 mYPAS scores assessed at the 3 predetermined points in the groups PD and C.
Distraction facilitates administration of premedication
Our study has limitations. The investigator assessing
mYPAS scores could not be blinded to the intervention be-
cause children's attitudes were not video recorded. However,
we minimized the bias by not informing the investigator about
the primary aim of the study and about the reason some chil-
dren played with PD and others did not. They were simply told
in detail how they should assess the anxiety scores. Another
limitation was missing data concerning children's previous
anxiety status; however, this limitation was previously shown
by others to be of no significance [12].
In conclusion, this study demonstrates that playing with PD
was useful in reducing premedication anxiety in young children.
It is a simple, safe, clean, inexpensive, and familiar toy. It requires
creativeness and high concentration, without sex preference.
Author's contribution
GBA and RP designed the study and collected the data,
GBA and SY generated the first draft of manuscript, and
JE generated the last draft of the manuscript. FKA, MS,
and ME performed the literature search. FKA and ÖO did
the statistics.
References
[1] Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety
in children: predictors and outcomes. Arch Pediatr Adolesc Med 1996;
150:1238-45.
[2] Davidson AJ, Shrivastava PP, Jamsen K, Huang GH, Czarnecki C,
Gibson MA, et al. Risk factors for anxiety at induction of anesthesia in
children: a prospective cohort study. Paediatr Anaesth 2006;16:919-27.
[3] JA M, GK B. Optimizing oral medications for children. Clin Ther 2008;
30:2120-32.
31
[4] Christiansen E, Chambers N. Induction of anesthesia in a combative
child; management and issues. Paediatr Anaesth 2005;15:421-5.
[5] Mennella JA, Spector AC, Reed DR, Coldwell SE. The bad taste of med-
icines: overview of basic research on bitter taste. Clin Ther 2013;35:
1225-46.
[6] Viitanen H, Annila P, Viitanen M, Yli-Hankala A. Midazolam premedi-
cation delays recovery from propofol-induced sevoflurane anesthesia in
children 1-3 yr. Can J Anaesth 1999;46:766-71.
[7] McGraw T, Kendrick A. Oral midazolam premedication and postopera-
tive behaviour in children. Paediatr Anaesth 1998;8:117-21.
[8] Stewart SH, Buffett-Jerrott SE, Finley GA, Wright KD, Valois GT. Ef-
fects of midazolam on explicit vs implicit memory in a pediatric surgery
setting. Psychopharmacology 2006;188:489-97.
[9] Bozkurt P. Premedication of the pediatric patient - anesthesia for the un-
cooperative child. Curr Opin Anaesthesiol 2007;20:211-5.
[10] Golan G, Tighe P, Dobija N, Perel A, Keidan I. Clowns for the preven-
tion of preoperative anxiety in children: a randomized controlled trial.
Paediatr Anaesth 2009;19:262-6.
[11] Patel A, Schieble T, Davidson M, Tran MC, Schoenberg C, Delphin E,
et al. Distraction with a hand-held video game reduces pediatric preoper-
ative anxiety. Paediatr Anaesth 2006;16:1019-27.
[12] Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alle-
viates anxiety in children during induction of anesthesia. Anesth Analg
2012;115:1168-73.
[13] WMA. Declaration of Helsinki: ethical principles for medical research
involving human subjects. In: W.M Association, editor. 59th WMA
General Assembly; 2008 [Seoul].
[14] Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter
MB. The Yale Preoperative Anxiety Scale: how does it compare with a
“gold standard”? Anesth Analg 1997;85:783-8.
[15] Golden L, Pagala M, Sukhavasi S, Nagpal D, Ahmad A, Mahanta A.
Giving toys to children reduces their anxiety about receiving premedica-
tion for surgery. Anesth Analg 2006;102:1070-2.
[16] Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and
intervention strategies to alleviate preoperative anxiety in children: a crit-
ical review. Behav Modif 2007;31:52-79.
[17] Tatman A. In: Stoddart PA, Lauder GR, editors. The screaming child
in paediatric anaesthesia (problems in anaesthesia). London: Taylor &
Francis; 2004. p. 145-52.
[18] Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang
SM, Gaal D. Trends in the practice of parental presence during induction
of anesthesia and the use of preoperative sedative premedication in the
United States, 1995-2002: results of a follow-up national survey. Anesth
Analg 2004;98:1252-9.