The Effects of Operating Room Virtual Tour on Preoperative Anxiety, Emergence Delirium and Postoperative Behavioral Changes of Pediatric Patients: Prospective, Randomized, and Controlled Trial
Phase: NA
Conditions: Preoperative Care, Anxiety, Emergence Delirium, Postoperative Complications
Sponsor: Seoul National University Bundang Hospital

The Effects of Operating Room Virtual Tour on Preoperative Anxiety, Emergence 
Delirium and Postoperative Behavioral Changes of Pediatric Patients: Prospective, 
Randomized, and Controlled Trial 
 
NCT number: NCT03172182 
 
Updated date: 01/09/2018  

Study  
The protocol of this prospective, randomized and controlled clinical trial was approved by the 
institutional review board of Seoul National University Bundang Hospital (B-1705-396-302) 
and registered at Clinical Trials Registry (registration number NCT 03172182, https:// 
clinicaltrials.gov). All children and parents/guardians received appropriate explanation of this 
study prior to admission. Written informed consent was obtained from parents/guardians of all 
children, and assent was also obtained from children older than the age of 7 years. This study 
was performed at Seoul National University Bundang Hospital, between June and October of 
2017. 
 
Virtual reality tour of the operating theater 
The 4-min video of the VR tour, a 360∘ movie, introduced and explained the perioperative 
preparation process. In this video, Pororo, the famous little penguin character, acts as a pediatric 
patient who is scheduled be on a tour of the operating theater before surgery. After admission, 
Pororo changes into a theater gown and intravenous catheter is placed in his forearm. Then, he 
is transported to the operating theater after confirming his identity in the reception area of the 
operating theater. Monitoring devices, including ECG, non-invasive blood pressure cuff and 
pulse oximeter are placed. A facial mask is applied for induction of general anesthesia. During 
the tour, Pororo explains the preoperative procedure in detail and emphasized that all children 
can undergo this same process without difficulty.   
The script of the VR video was written by an anesthesiologist from Seoul National 
University Bundang Hospital, and doctors and nurses of this hospital acted in the movie, 
wearing costumes of animation characters. The VR video was produced in collaboration with 

IONIX (Seongnam, Korea) and VR producing company (The VR Co, Seoul, Korea). Seoul 
National University Bundang Hospital signed a memorandum of understanding with ICONIX 
to use the animation character Pororo and other characters from the animated film ‘Pororo The 
Little Penguin’ (©ICONIX/OCON/EBS/SKBroadband). Filming was carried out using three 
adapted GoPro Hero4® VR cameras (GoPro, San Mateo, California, USA) by a professional 
VR company (The VR Co.) in the operating theater of the hospital. The video was then turned 
into an application for mobile devices. The VR tour was provided using smartphones (Galaxy 
S6®; Samsung, Suwon, Korea) and VR headsets (VR Gear®; Samsung). 
 
Patients 
A total of 86 children, aged 4-10 years with the American Society of Anesthesiologist (ASA) 
physical status of I or II, undergoing general anesthesia and elective surgery were enrolled for 
this study. The exclusion criteria included the following: children requiring major surgery or 
postoperative intensive care; those with a history of prematurity or congenital disease; those 
with hearing impairment; those with cognitive deficits or cognitive and intellectual 
developmental disabilities; those who had an experience of anesthesia previously; those taking 
psychoactive medications; and those with a history of epilepsy or seizure. 
 
Randomization  
Randomization was conducted by an independent anesthesiologist who was in charge of 
patient allocation at 2 h prior to arrival at the preoperative reception area of the operating theater. 
A computer-generated randomized code (Random Allocation Software version 1.0; University 
of Medical Sciences, Isfahan, Iran) with nontransparent envelopes that contained sequential 

numbers was used. The allocation ratio was 1: 1. The outcome assessor and an anesthesiologist 
were blinded to group assignment, although children and their parents/guardians were not 
blinded.   
 
Intervention 
Enrolled children were randomly assigned into either the control (n = 43) or VR group (n = 
43), and the intervention was done by a researcher in a separate empty room 1 h prior to 
entering the operating theater to exclude any possible external interferences. Children and 
parents/guardians in the control group received conventional informative education regarding 
the perioperative process. Those in the VR group received a VR-guided tour of the operating 
theater via a smartphone application with a VR headset. After the intervention, an 
anesthesiologist asked each child and accompanying parent/guardian if they had any questions 
regarding the perioperative procedures.   
 
Anesthesia 
Children were transported from the pre-anesthetic reception are to the operating theater 
accompanied by their parent/guardian without premedication. Induction of anesthesia was 
performed by an anesthesiologist with at least 2 years of experience. Standard monitoring 
devices, including ECG, non-invasive blood pressure cuff, and pulse oximeter, were placed; 5 
mg/kg thiopental sodium was administered intravenously while oxygenation was carried out 
using a facial mask. Upon confirming the disappearance of the eyelid reflex, parent/guardian 
was guided to the waiting room. Mask ventilation with sevoflurane in oxygen (5 l/min) in 
increments was commenced to reach the maximum vaporizer setting within a few breaths, and 

rocuronium 0⋅3–0⋅6mg/kg was given for endotracheal intubation. Anesthesia was maintained 
with sevoflurane with medical air in oxygen (fraction of inspired oxygen 0.5). At the end of the 
operation, sevoflurane was discontinued, and glycopyrrolate and neostigmine were given to 
reverse the neuromuscular blockade. Children were transferred to the postanesthesia care unit 
(PACU) after extubation. 
 
Outcomes 
The primary outcome was the incidence and degree of ED. The degree of ED was measured 
using Pediatric Anesthesia Emergence Delirium (PAED) scale (Appendix 1) by the blinded 
assessor at 5 min after the arrival of PACU. 
Secondary outcomes included the preoperative anxiety scores and postoperative behavior 
disturbances. Preoperative anxiety was measured using the validated Korean version of m-
YPAS) (Appendix 2) by the blinded single assessor to exclude any interrater biases. The m-
YPAS score was evaluated on each child twice: baseline (at the time of admission before the 
study intervention) and just prior to the induction of anesthesia (when the child was placed on 
the stretcher for transportation from the bed to the operating theater). Postoperative behavior 
disturbances were recorded using Post-Hospitalization Behavior Questionnaire for Ambulatory 
Surgery (PHBQ-AS) (Appendix 3) by calling to their parents/guardians on 1 and 14 days after 
surgery. 
 
Sample size 
Power analyses were undertaken using G*Power 3.1.2 (Heinrich-Heine University, 

Düsseldorf, Germany). The sample size of the current study was based on the previous 
investigation on the emergence delirium. The incidence of emergence delirium of the control 
group (without intervention) was 40.6%, and the reduction of 30% in the incidence of delirium 
was considered to be clinically significant. A sample size of 43 children per group was 
determined with a significance level of 0⋅05 (α = 0.05) and a power of 80 percent (β = 0.20), 
allowing for a 10 % dropout rate. 
 
Statistical analysis 
All data in this study are presented as the median (interquartile range) or numbers (%). SPSS 
21.0 for Windows (IBM, Armonk, New York, USA) was used for all statistical analyses. The 
test of normal distribution was assessed using Shapiro–Wilk test. Mann–Whitney U test was 
used for analyses of continuous variables (age, weight, height, induction time, m-YPAS, PAED 
scale and PHBQ-AS) and χ2 test was used for categorical variables (gender, ASA physical class 
and incidence of ED). A full analysis set was used for data analysis. P of less than 0.050 was 
considered statistically significant. 
 
 

Appendix 1. The Pediatric Anesthesia Emergence Delirium (PAED) scale. 
 
Behaviour 
Not at 
all 
Just a 
little 
Quite a 
bit 
Very 
much 
Extremely 
Makes eye contact  
with caregiver 
4 
3 
2 
1 
0 
Actions are purposeful 
4 
3 
2 
1 
0 
Aware of surroundings 
4 
3 
2 
1 
0 
Restless 
0 
1 
2 
3 
4 
Inconsolable 
0 
1 
2 
3 
4 
 
Total score :  
 
 
 

Appendix 2. mYPAS (modified Yale preoperative anxiety scale) 
A. Activity _____  
B. Vocalizations _____  
C. Emotional Expressivity _____  
D. State of Arousal _____  
E. Use of Parent _____  
 
A. Activity  
0. Can’t code (child not visible)  
1. Looking around, curious, playing with toys, reading (or other age appropriate behavior); 
moves around holding area/ treatment room to get toys or go to parent; may move toward OR 
equipment  
2. Not exploring or playing, may look down, may fidget with hands or suck thumb (blanket); 
may sit close to parent while waiting, or play has a definite manic quality  
3. Moving from toy to parent in unfocused manner, nonactivity derived movements; 
frenetic/frenzied movement or play; squirming, moving on table, may push mask away or 
clinging to parent  
4. Actively trying to get away, pushes with feet and arms, may move whole body; in waiting 
room, running around unfocused, not looking at toys or will not separate from parent, 
desperate clinging  
B. Vocalizations  
0. Can't code (child not visible or can't hear audio)  
1. Reading (nonvocalizing appropriate to activity), asking questions, making comments, 
babbling, laughing, readily answers questions but may be generally quiet; child too young to 

talk in social situations or too engrossed in play to respond  
2. Responding to adults but whispers, "baby talk", only head nodding  
3. Quiet, no sounds or responses to adults  
4. Whimpering, moaning, groaning, silently crying  
5. Crying or may be screaming "no"  
6. Crying, screaming loudly, sustained (audible through mask)  
C. Emotional Expressivity  
0. Can't code (can't see face or child not visible)  
1. Manifestly happy, smiling, or concentrating on play  
2. Neutral, no visible expression on face  
3. Worried (sad) to frightened, sad, worried, or tearful eyes  
4. Distressed, crying, extreme upset, may have wide eyes  
D. State of Apparent Arousal  
0. Can't Code (child not visible)  
1. Alert, looks around occasionally, notices watches what anesthesiologist does with him/her 
(could be relaxed)  
2. Withdrawn child sitting still and quiet, may be sucking on thumb or face turned into adult  
3. Vigilant looking quickly all around, may startle to sounds, eyes wide, body tense  
4. Panicked whimpering, may be crying or pushing others away, turns away  
E. Use of Parents  
0. Can't code (child not visible)  
1. Busy playing, sitting idle, or engaged in age appropriate behavior and doesn’t need parent; 
may interact with parent if parent initiates the interaction  
2. Reaches out to parent(approaches parent and speaks to otherwise silent parent), seeks and 
accepts comfort, may lean against parent  

3. Looks to parents quietly, apparently watches actions, doesn't seek contact or comfort, 
accepts it if offered or clings to parent  
4. Keeps parent at distance or may actively withdraw from parent, may push parent away or 
desperately clinging to parent and will not let parent go  
 
Total adjusted score = (A/4 + B/6 + C/4 + D/4 + E/4) × 100/5 
 
 
 

Appendix 3. Post Hospitalization Behavior Questionnaire for Ambulatory Surgery 
(PHBQ-AS) 
 
Does your child make a fuss about eating? 
Does your child spend time just sitting or lying and doing nothing? 
Is your child uninterested in what goes on around him (or her)? 
Does your child get upset when you leave him (or her) alone for a few minutes? 
Does your child need a lot of help doing things? 
Is it difficult to get your child interested in doing things (like playing games with toys)? 
Does your child have temper tantrums? 
Is it difficult to get your child to talk to you? 
Does your child have bad dreams at night or wake up and cry? 
Does your child have trouble getting to sleep at night? 
Does your child have a poor appetite? 
 
 
Total Score (Each 1):