Evaluation of Virtual Reality Intervention After Pediatric Idiopathic Scoliosis Surgery to Reduce Postoperative Pain and Opioid Consumption
Phase: NA
Conditions: Scoliosis Idiopathic, Pain, Postoperative
Sponsor: University of North Carolina, Chapel Hill

STUDY PROTOCOL 
 
Evaluation of Virtual Reality Intervention after Pediatric Idiopathic 
Scoliosis Surgery to Reduce Postoperative Pain and Opioid 
Consumption 
 
 
NCT number NCT04584970 
Document Date 05/17/2020 
 

 
1 
PROTOCOL TEMPLATE: INTERVENTIONAL STUDY 
 
 
Complete Title: Evaluation of Virtual Reality Intervention after Pediatric Idiopathic Scoliosis Surgery to Reduce 
Postoperative Pain and Opioid Consumption 
 
 
 
 
 
Short Title: Virtual Reality after Pediatric Scoliosis Surgery (VRAS-PS) 
 
Drug or Device Name(s): Applied VR 
 
Sponsor: University of North Carolina Hospitals 
 
Protocol Date: April 20, 2020 
 
Amendment 1 Date: May 17, 2020 
Amendment 2 Date:  
Amendment 3 Date: 
Amendment 4 Date:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
University of North Carolina Hospitals 
101 Manning Drive 
Chapel Hill, NC, 27514 
USA 
Marley Lawrence 
101 Manning Drive, N2198, CB# 7010 
Chapel Hill, NC, 27599 
Phone 828-337-1012 
Marley_Lawrence@med.unc.edu 

 
2 
PROTOCOL TITLE: Evaluation of Virtual Reality Intervention after Pediatric Idiopathic Scoliosis Surgery to 
Reduce Postoperative Pain and Opioid Consumption 
 
SHORT TITLE: Virtual Reality after Pediatric Scoliosis Surgery 
 
 
 
 
 
Lead Investigator: 
Marley Lawrence, M.D. 
 University of North Carolina at Chapel Hill 
Protocol Version: 1.1  
Version Date: May 17, 2020 
 
 
 
I confirm that I have read this protocol and understand it.    
 
 
Principal Investigator Name:   
 
Marley Lawrence, MD 
 
Principal Investigator Signature:  
 
 
 
 
 
 
Date:   
 
 
 
 
May 17, 2020  
 
 

 
3 
TABLE OF CONTENTS 
Table of Contents ........................................................................................................... 3 
Abbreviations and Definitions of Terms .......................................................................... 4 
Protocol Synopsis ........................................................................................................... 5 
1 BACKGROUND  AND RATIONALE ....................................................................................... 9 
2 STUDY OBJECTIVES ........................................................................................................... 11 
3 INVESTIGATIONAL PLAN ................................................................................................... 11 
4 STUDY PROCEDURES ........................................................................................................ 14 
5 STUDY EVALUATIONS AND MEASUREMENTS .................................................................. 15 
6 STATISTICAL CONSIDERATIONS ........................................................................................ 17 
7 STUDY INTERVENTION (DEVICE OR OTHER INTERVENTION) ........................................... 18 
8 STUDY INTERVENTION ADMINISTRATION ....................................................................... 18 
9 SAFETY MANAGEMENT .................................................................................................... 19 
10  DATA COLLECTION AND MANAGEMENT ......................................................................... 19 
11 RECRUITMENT STRATEGY ................................................................................................ 19 
12 CONSENT PROCESS ........................................................................................................... 19 
13 PUBLICATION .................................................................................................................... 20 
14 REFERENCES ..................................................................................................................... 20 
Appendix .......................................................................................................................21 
 
 
 

 
4 
 
 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Abbreviation  
Definition 
 
 
E-consent 
Electronic consent 
ERAS 
Enhanced Recovery After Surgery 
FLACC 
Face, Legs, Arms, Cry and Consolability  
PACU 
Post anesthesia care unit 
PCA 
Patient controlled analgesia 
PHBQ-AS 
Post Hospitalization Behavior Questionnaire for Ambulatory Surgery 
POD 
Postoperative day 
STAI 
State-Trait Anxiety Inventory 
VR 
Virtual reality 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
5 
PROTOCOL SYNOPSIS 
Study Title 
Evaluation of Virtual Reality Intervention after Pediatric Idiopathic 
Scoliosis Surgery to Reduce Postoperative Pain and Opioid 
Consumption 
Funder 
UNC Department of Anesthesiology Research Department  
Clinical Phase 
N/A 
Study Rationale 
• 
Pain is common after surgery, and can be influenced by many 
factors, including anxiety 
• 
Distraction methods are commonly used with pediatric patients 
at UNC including the use of iPads postoperatively  
• 
Studies have shown that pain, anxiety and patient satisfaction 
are improved with the use of distraction  
• 
Studies have compared these standard distraction methods to 
the use of virtual reality and have shown that VR is an effective 
way to reduce anxiety, decrease pain, and improve patient 
satisfaction 
• 
The majority of these studies have been done either during 
minor procedures or preoperatively as an introduction to the 
patient experience 
• 
Little has been done to study VR in the postoperative period, 
particularly on the first postoperative day 
• 
Scoliosis surgery is a common pediatric procedure that can be 
associated with significant postoperative pain  
Study Objective(s) 
Primary  
• 
To evaluate postoperative pain scores and postoperative opioid 
use in pediatric idiopathic scoliosis surgical patients using virtual 
reality as a method of immersive distraction compared with 
standard electronic use postoperatively.  
Secondary 
• 
To evaluate patient satisfaction with use of virtual reality as a 
method of distraction.  
Device Description 
The Applied VR is a lightweight mobile virtual reality headset with 
embedded software, creating an immersive experience. The Applied 
VR is specifically designed for medical use.  
Study Design 
 
Randomized controlled pilot study comparing virtual reality to 
standard electronic use (iPad) after idiopathic scoliosis surgery. 
Patients age 11-17 years old will be included and randomized to 
either the virtual reality or control (iPad) group. The randomization-
and-concealment feature of REDCap data capture system will be 
utilized.  

 
6 
Subject eligibility will be verified by the research coordinator 
through chart review and patient questionnaire prior to enrollment 
in the study.  
In the VR arm, VR devices will be used with pre-selected virtual 
reality program options. In the control arm, patients will be offered 
an iPad preloaded with a variety of games. Both groups of 
participants will also receive the postoperative standard of care 
including a PCA for pain control.  
Preoperatively: 
• 
Baseline anxiety score (STAI score) will be assessed  
• 
Baseline pain scores will be obtained: FACES scale (patient 
reported) and FLACC score (measured by the trained 
research assistant)  
• 
Baseline vitals will be measured  
• 
Patients will be oriented to their respective devices 
Intraoperatively: 
• 
Must be on ERAS idiopathic scoliosis pathway at our 
institution 
Postoperatively: 
• 
Must be admitted to the general pediatric floor post-
operatively (versus intensive care unit) 
• 
On POD #1 in the morning, patients in both groups will be 
visited by the research assistant. Patients in the VR arm will 
be offered the VR device for up to 30 minutes, and patients 
in the control arm will be offered an iPad for up to 30 
minutes 
• 
Number of hours since anesthesia end will be recorded 
• 
Pain scores (FACES scale by the patient, FLACC scores by the 
research assistant) will be recorded immediately prior to 
intervention (T=0) and at end of intervention (T=30); FLACC 
score by research assistant will also be recorded at 10 
minute mark (T=10) 
• 
PCA use (in mcg or mg as appropriate) for previous hour 
prior to intervention (T=-60-0), during intervention (T=0-30), 
and one hour after intervention is complete (T=30-90) will 
be recorded; PCA use will be converted to morphine 
equivalents at time of data entry 
• 
Total number of minutes of electronic device use will be 
recorded. The electronic device will be applied for a total of 
30 minutes maximum, after which time the session will end 
• 
On POD #1 in the afternoon, research assistant will return 
for patients in both groups, for another session up to 30 
minutes. Data for both groups will be recorded as above 

 
7 
• 
If a patient declines to participate, the reason for declining 
will be asked for and recorded 
Post-intervention: 
• 
Patients and caregivers in the VR group will be given a 
survey regarding acceptance and effectiveness of the VR 
device in the postoperative period at approximately 48-72 
hours  
• 
Patients and caregivers in both groups will be given a follow-
up survey at approximately 48-72 hours and 7-10 days  
• 
Surveys will be conducted by phone, email or in person 
Subject Population 
key criteria for Inclusion 
and Exclusion: 
Inclusion Criteria 
1. Subjects age 11 – 17 
2. Patients undergoing idiopathic scoliosis surgery on ERAS 
spine protocol (which includes postoperative PCA) 
3. No contraindication to using an iPad or VR device 
Exclusion Criteria 
1. Patient/caregiver refusal  
2. Patients with developmental delay 
3. Patients with seizure disorder 
4. Non-English-speaking patients 
5. Patients with daily opioid use ≥ two weeks 
6. Patients with uncorrected visual or hearing impairment 
7. Patients admitted to pediatric intensive care unit on POD#1 
Number of Subjects  
At most 24 enrollees (goal 10 completed participants in each arm) 
Study Duration 
Each subject’s participation will last ~120 minutes  
• 
Day of surgery: 30 minutes, which includes recruitment and 
consent, baseline anxiety and pain scores, and orientation 
• 
Postoperative (POD #1): 35 minute visits x 2, which include 
pain scores, 30 minutes of electronic device use, and PCA 
use data 
• 
Postoperative (approximately 48-72 hours and 7-10 days 
postoperatively): 10 minutes for each survey 
The anticipated duration of the study is 3-4 months 
Study Phases 
  
(1) Screening: screening for eligibility and obtaining consent 
(2) Intervention: study intervention and data collection 
(3) Follow up: post intervention surveys and data analysis 
Efficacy Evaluations 
To evaluate efficacy of VR for pain control, the following will be 
recorded:  
• 
Postoperative pain scores 
• 
Postoperative PCA usage surrounding intervention 

 
8 
• 
Patient & caregiver satisfaction scores 
• 
Presence of dizziness/nausea 
• 
Time of discontinuation of VR if less than 30 minutes  
Safety Evaluations 
Safety and feasibility of VR in postsurgical populations has been 
proven in previous studies, some of which include specific spine 
surgery populations. 
Statistical And Analytic 
Plan 
Quantitative data analysis will be conducted under the supervision 
of the biostatistician, using SAS or R.  
 
All statistical estimates (e.g., means, medians, proportions, 
incidence rates, mean differences, correlations, etc.) will be 
tabulated along with corresponding confidence intervals (CIs). To 
avoid over-reliance on p-values, the magnitudes of estimates and 
the corresponding confidence intervals will be the primary focus of 
the analyses. 
Data and Safety 
Monitoring Plan 
The data collected during this study will be on hospital or School of 
Medicine computers with security features installed to protect the 
data. Data will be collected by a research assistant and will be 
monitored by members of the research study and other members 
of the Department of Anesthesiology research division. 
The Information Technology group within the Department of 
Anesthesiology provides secure data storage for the proposed 
study. Servers for the group are located in a locked office on the 
UNC campus. Study data on these servers is stored on SQL Server 
2005s and backed up with nightly full backups. The web server is 
behind a firewall and only known and approved site users have 
access via ASP.NET forms authentication. This data management 
system meets or exceeds NIH security guidelines, safeguards 
participant data, and adheres to the Certificate of Confidentiality.  
Any adverse events will be collected in the data and reported to the 
PI and IRB as applicable. Based on the results, modifications in the 
postoperative management protocols at UNC will be considered as 
appropriate. 
 
 
 

 
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1 
BACKGROUND AND RATIONALE 
 
 
1.1 
Introduction 
Pain is a common complaint after surgery, and can be influenced by many factors, including anxiety. 
Distraction methods are commonly used with pediatric patients in the perioperative period to 
decrease patient and caregiver anxiety both before and during procedures. UNC and the Child Life 
team routinely use a variety of games and videos to assist in easing the pre- and postoperative 
experience for children and their families. Studies have shown that pain, anxiety and patient 
satisfaction are improved with the use of distraction methods as compared to treatment with 
medications alone. Studies have also compared these standard distraction methods to the use of 
virtual reality during minor procedures (dressing changes, IV lines, vaccines) and have shown that VR is 
an effective way to reduce anxiety, decrease pain, and improve patient satisfaction during these 
procedures. The majority of these studies have been done either during minor procedures or 
preoperatively as an introduction to the patient experience. In addition, studies show improvement in 
rehabilitation in certain populations. Little has been done to study VR in the postoperative period, 
particularly on the first postoperative day. Our group previously investigated VR use in the PACU 
following a broad range of pediatric surgeries last year, with favorable results. This study will focus on 
patients specifically undergoing pediatric scoliosis surgery, and will examine the use of VR on the first 
postoperative day. Scoliosis surgery is a common pediatric procedure that can be associated with 
significant postoperative pain. This study and data collection will be done at UNC Hospitals, including 
the Children’s preoperative holding area and the Children’s inpatient floors postoperatively.   
  
1.2 
Name and Description of Investigational Product or Intervention  
The Applied VR is a lightweight mobile virtual reality headset with embedded software, creating an 
immersive experience. The Applied VR is specifically designed for medical use. Our group has received 
funding approval for a UNC Department of Anesthesiology grant to acquire 2 Applied VR units. (date of 
request 4/9/2020, date of approval 4/13/2020). These funds grant us the ability to purchase 2 
AppliedVR devices which includes the 12 month research subscription plan – software license, tech 
support, training, Pico G2 4K hardware ($5000 total). We have successfully purchased these devices.  
 
In comparison with the Oculus Go headsets used in our prior research study, the Applied VR carries 
several advantages including: lighter weight headsets; specific design for medical intervention with a 
HIPAA compliant platform; enhanced immersion including improved audio-visual synchronization, 
higher pixel count, 4K device (vs 3K device); improved infection control capability due to rubber straps 
instead of Velcro. Applied VR is manufactured by a leading virtual reality company that is defined as a 
wellness company; they have not achieved FDA approval given that they are considered as wellness 
devices. They have numerous studies demonstrating their software’s impact on pain and anxiety. In 
addition, their headsets’ more lightweight and comfortable design will be important in our pediatric 
patents. 
In keeping with our group’s accepted IRB application last year regarding postoperative virtual reality 
research, we plan to request a device determination from the IRB. We have determined that the device 
as used in this investigation meets the criteria for a non-significant risk (NSR) device. 
 

 
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1.3 
Non-Clinical and Clinical Study Findings 
By exploring non-pharmacologic methods of postoperative pain management in the form of virtual 
reality distraction, we hope to contribute to effective means of management for the common 
condition of postoperative pain. Postoperative risks associated with children are related to opioid 
administration and include over-sedation, respiratory depression, nausea and vomiting, and increased 
PACU stay. By providing a non-pharmacologic distraction method, we plan to minimize postoperative 
pain, opioid requirements, and lessen their possible adverse effects. As a result, children may receive 
fewer opioids, while benefiting from a positive hospital experience that is patient centered and age 
appropriate. There is a known small risk of motion sickness and nausea with the use of VR, but we 
believe that this risk will not be different in our study population, as evidenced by our previous VR 
study. 
 
1.4 
Relevant Literature and Data 
Arane K, Behboudi A, Goldman RD. Virtual reality for pain and anxiety management in children. Can 
Fam Physician. 2017;63(12):932-934. 
 
Eijlers R et al. Development of a virtual reality exposure tool as psychological preparation for elective 
pediatric day care surgery: Methodological approach for a randomized controlled trial. JMIR Res 
Protoc. 2017;6(9):e174. 
Gold JI, Mahrer NE. Is virtual reality ready for prime time in the medical space? A randomized control 
trial of pediatric virtual reality for acute procedural pain management. J Pediatr Psychol. 
2018;43(3):266-275. 
Jenkins BN et al. Revisiting a common measure of child postoperative recovery: Development of the 
post hospitalization behavior questionnaire for ambulatory surgery (PHBQ-AS). Paediatr Anaesth. 
2015;25(7):738-745. 
 
Nilsson S et al. Assessing children's anxiety using the modified short state-trait anxiety inventory and 
talking mats: A pilot study. Nursing Research and Practice. 2012;932570. 
Nilsson S et al. School-aged children's experiences of postoperative music medicine on pain, distress, 
and anxiety. Paediatr Anaesth. 2009;19(12):1184-90. 
Parsons TD et al. Virtual reality in paediatric rehabilitation: A review. Dev Neurorehabil. 
2009;12(4):224-38. 
Piskorz J, Czub M. Effectiveness of a virtual reality intervention to minimize pediatric stress and pain 
intensity during venipuncture. J Spec Pediatr Nurs. 2018;23(1). 
Ryu JH et al. Randomized clinical trial of immersive virtual reality tour of the operating theatre in 
children before anaesthesia. Br J Surg. 2017;104:1628–1633. 
Won AS et al. Two virtual reality pilot studies for the treatment of pediatric CRPS. Pain Med. 
2015;16(8):1644-7. 

 
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2 
STUDY OBJECTIVES  
The purpose of this study is to determine whether the use of virtual reality after pediatric idiopathic 
scoliosis surgery influences pain perception. We hypothesize that the use of virtual reality programs 
will provide superior distraction to standard electronic use and will result in improved pain scores and 
reduced opioid consumption after surgery. 
 
2.1 
Primary Objective 
To evaluate postoperative pain scores and postoperative opioid use in pediatric idiopathic scoliosis 
surgical patients using virtual reality as a method of immersive distraction compared with standard 
electronic use (iPad) postoperatively.  
 
2.2 
Secondary Objective 
To evaluate patient satisfaction with use of virtual reality as a method of distraction.  
 
3 
INVESTIGATIONAL PLAN 
 
3.1 
Study Design 
This will be a randomized controlled pilot study comparing virtual reality to standard electronic use 
after pediatric idiopathic scoliosis surgery. Patients age 11-17 years old undergoing idiopathic scoliosis 
surgery will be included. Patients will be randomized to either the virtual reality or control (iPad) 
group. The randomization-and-concealment feature of REDCap data capture system will be utilized. 
 
Subject eligibility will be verified by the research coordinator through chart review and patient 
questionnaire prior to enrollment in the study. The patients will be blinded to their study arm until 
they agree to be part of the study. Participants will be properly oriented to their respective device (VR 
or iPad) before surgery. While the use of VR may be new to the patients, VR is a very popular, trending 
and mainstream concept that is not likely to be unfamiliar to patients in the study age group. The 
patients will have the ability to stop using the VR device at any time if they choose. 
 
Study phases are as follows: 
Screening/Consent/Baseline: Randomization and consent will be obtained preoperatively. A baseline 
anxiety score will be assessed on a self-report form (STAI short form). Patients in the VR arm will be 
oriented to the VR device before surgery. All patients will be oriented to the Wong-Baker FACES pain 
scale. Baseline pain scores will be obtained through the following method: FACES scale (patient 
reported) and FLACC score (measured by the trained research assistant). Baseline vital signs will be 
measured and recorded. The STAI, FACES, and FLACC scoring tools have all been used and previously 
validated in the pediatric population.  
 
Intervention/Treatment: On postoperative day (POD) #1 in the morning, patients in both groups will be 
visited by the research assistant. Standardized scripts will be utilized by the research assistant for the 
entirety of the data collection. Patients in the VR arm will be offered the VR device for up to 30 
minutes. Patients in the control arm will be offered an iPad for up to 30 minutes. After a total of 30 
minutes maximum, the session will end. Routine data will be collected on pain scores and PCA use as 
below for both groups. On POD #1 in the afternoon, a research assistant will return for patients in both 

 
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groups, for another session of the respective electronic device for up to 30 minutes. If a patient 
declines to participate, the reason for declining will be asked for and recorded. 
 
In the control arm of the study, the iPad will have a variety of vetted and screened games available. 
The content on the iPads will include puzzles, games, and movies that have been previously vetted and 
approved by the Child Life team, separate from this study, and are currently used as standard of care at 
UNC. The Child Life team is an integral part of pediatric postoperative recovery at UNC.  
 
In the VR arm of the study, there will be selected programs to choose from. All of the content will be 
pleasant games or exploring programs, avoiding unpleasant and fast-moving settings such as fighting 
or racing. All of the content will be age appropriate, vetted and screened by the research team for 
violence or otherwise stressing scenarios, content requiring rapid eye motion or head movement, and 
content requiring more body movement than what can comfortably be done in a sitting or reclined 
position. 
 
Both iPads and VR devices are interactive (regardless of fingers versus head movement) and this type 
of movement difference should not confound results. Our study aims to assess whether the VR 
immersive experience provides superior distraction to the standard of care (iPad use), thus by nature 
of the study design we are studying the difference in the two distinct types of experiences. Finger 
versus head movement use is inherent to the types of distraction and central to the distinct 
experiences. Similarly, there will be different apps between VR and iPad platforms by nature of the 
differences in platforms. Our goal is to examine whether an immersive experience is more beneficial 
than an iPad-based experience, rather than examine specific styles of games.  
 
There will be no restriction to personal electronic use. Both groups will have access to their personal 
devices (cell phones, iPads) as is the standard of care. The study iPad will only be offered at specific 
times as designated twice a day on POD#1 for participants in the control group. Outside of the study 
windows, participants will not be provided with hospital iPads. Personal electronic devices including 
iPads are acceptable, as is the standard of care for patients to bring whatever they see fit into the 
hospital.  
 
There will be a variety of popular games and apps, deemed to be content- and age-appropriate by the 
Child Life specialists. Program offerings will not vary by specific age or gender; our study will only 
include ages 11-17 and per discussion with Child Life the programs do not need to be subdivided to 
remain appropriate within this age range.  
 
Standard of care for both groups will include PCA use as ordered by the surgical team as well as routine 
Child Life visits. The Child Life team is an integral part of pediatric postoperative recovery at UNC.  
 
The following will be recorded: Number of hours since anesthesia end. Pain scores including FACES 
scale by the patient and FLACC scores by the research assistant will be recorded immediately prior to 
intervention (T=0) and at end of intervention (T=30); FLACC score will also be recorded at the 10 
minute mark (T=10). PCA use, in mcg or mg as appropriate, for the hour prior to intervention (T=-60-0), 
during intervention (T=0-30), and one hour after intervention is complete (T=30-90) will be recorded. 
Total number of minutes of electronic device use will be recorded. PCA use will be converted to 
morphine equivalents at time of data entry. 
 

 
13
The anesthetic management of the patients will be left to the discretion of the anesthesia provider on 
the day of surgery but will follow the guiding principles of the pediatric spine ERAS protocol, which 
standardizes many aspects of anesthetic care including multimodal analgesia, fluid management, etc. 
 
We are limiting our scope to POD#1 opioid usage. We do not hypothesize that VR use on POD#1 will 
affect opioid usage following hospital discharge. 
 
Follow up: A follow up survey will be given using the Post Hospitalization Behavior Questionnaire for 
Ambulatory Surgery (PHBQ-AS) form at approximately 48-72 hours postop and 7-10 days postop via a 
phone call, email or in person from a member of the research team. The PHBQ-AS form is used to 
assess new onset behavior change associated with hospitalization, which has been documented in 
numerous studies. We believe that by assessing preoperative anxiety and preventing perioperative 
pain, which can lead to behavioral changes, the use of VR may decrease the chance of post 
hospitalization behavior change. 
 
3.2 
Allocation to Treatment Groups and Blinding (if applicable) 
Patients will be randomized to one of two study arms. Each patient will have a private area 
preoperatively and postoperatively and no information about the other arm of the study will be 
disclosed, as to keep the study subjects blinded to the study. All study families and subjects will be 
consented/assented preoperatively, whether by phone in advance or in person on the morning of 
surgery. Patients will be blinded to the device upon consent for the study with the description of the 
use of an “electronic device” in the postoperative setting. This is deliberate, as to minimize any chance 
of bias. We feel that this is necessary due to the popularity and growing public interest in VR.  
  
3.3 
Study Duration, Enrollment and Number of Subjects 
The anticipated duration of the study is 3-4 months, with total enrollment time of up to 13 days for 
each patient. This enrollment period includes: preoperative screening and consent, as well as the 
postoperative intervention and data collection (roughly 100 minutes); follow up survey 48-72 hours 
post op (roughly 10 minutes); and follow up survey 7-10 days postop (roughly 10 minutes). We plan to 
enroll at most 24 patients for this pilot study, with a final goal of 10 completed participants in each 
arm.  
 
3.4 
Study Population 
Inclusion Criteria: 
• 
Subjects age 11 – 17 years of age 
• 
Patients undergoing idiopathic scoliosis surgery on ERAS spine protocol (which includes 
postoperative PCA) 
• 
No contraindication to using an iPad or VR device 
 
Exclusion Criteria: 
• 
Patient/caregiver refusal  
• 
Patients with developmental delay 
• 
Patients with seizure disorder 
• 
Non-English-speaking patients 

 
14
• 
Patients with daily opioid use ≥ two weeks 
• 
Patients with uncorrected visual or hearing impairment 
• 
Patients admitted to pediatric intensive care unit on POD#1 
 
4 
STUDY PROCEDURES 
 
4.1 
Screening/Baseline Visit procedures 
Baseline anxiety score will be assessed on a self-report form (STAI short form). The patients will be 
oriented to their study arm and to the VR device if assigned to that arm. The patient will be oriented to 
the Wong-Baker FACES pain scale. Baseline pain scores will be obtained through the following method: 
FACES scale (patient reported) and FLACC score (measured by the trained research assistant). Baseline 
vital signs will be measured and recorded in the preoperative area. All assessment modalities have 
been used and validated in the pediatric population.  
 
4.2 
Intervention/Treatment procedures (by visits) 
There will be two intervention/treatment visits, both occurring on POD#1. On POD#1 in the morning, 
patients in both groups will be visited by the research assistant. Patients in the VR arm will be offered 
the VR device for up to 30 minutes. Patients in the control arm will be offered an iPad for up to 30 
minutes. After a total of 30 minutes maximum, the session will end. Routine data will be collected on 
pain scores and PCA use as above for both groups. On POD #1 in the afternoon, a research assistant 
will return for patients in both groups. For participants in the intervention group, this VR session will be 
again offered for up to 30 minutes. Patients in the control arm will be offered an iPad for up to 30 
minutes. If a patient declines to participate, the reason for declining will be asked for and recorded. 
 
To evaluate efficacy, the following will be recorded:  
• 
Primary outcomes: 
o Postoperative pain scores 
o Postoperative PCA opioid use surrounding intervention (morphine equivalents) 
 
• 
Secondary outcomes: 
o Patient and caregiver satisfaction scores 
o Presence of dizziness/nausea 
o Time of discontinuation of VR if less than 30 minutes  
 
4.3 
Follow-up procedures (by visits) 
There will be a follow-up survey using the PHBQ-AS form to assess new onset behavior change at 
approximately 48-72 hours postop and 7-10 days postop via a phone call from a member of the 
research team. These scores will be recorded and analyzed between both study groups.  
 
4.4 
Unscheduled visits 
Not applicable  
 
4.5 
Concomitant Medication documentation 

 
15
PCA opioid use surrounding intervention (morphine equivalents), at time intervals as detailed above, 
will be recorded. Any anti-nausea medication requested during the intervention will be recorded. 
Given that our study will take place on POD#1, perioperative medications given intra-operatively will 
not be included for analysis.  
 
4.6 
Rescue medication administration 
Addressed in section 4.5 
 
4.7 
Subject Completion/ Withdrawal procedures 
Patients and/or caregivers can withdraw from the study at any time for any reason, and this will be 
documented. Standard of care practices will not be influenced by inclusion, exclusion or withdrawal 
from the study. If patients are excluded from the study at any point, the reason(s) will be noted, and 
every effort will be made to replace that patient with another subject within the same subgroup. The 
goal is to have 10 patients in each arm complete the study. Study duration will be up to 13 days for 
each patient and will conclude following the second postoperative telephone survey or after 
postoperative day 13, whichever comes first.  
 
4.8 
Screen failure procedures 
Patients that fail to be screened and considered for the study will not be included.  
 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
o Variables that will be abstracted from the medical charts:  
• 
Name, medical record number, phone number 
• 
Age (years), gender (male or female), race or ethnicity, weight (kg), BMI (kg/m2), heart rate (0-
200 beats/min), and blood pressure (0-250/0-150 mmHg) pre-operatively 
• 
Surgery type, current medications 
• 
Pain scores, vital signs 
• 
Intraoperative record 
o Baseline evaluation will include chart review, by phone or in person assessment for inclusion and 
exclusion criteria, vital sign assessment, study consent and orientation. 
o Preoperatively, baseline vital signs will be obtained and recorded by nursing staff per UNC standard 
of care practices. Additionally, two pain scores will be assessed: FACES by the patient and FLACC by 
the research assistant. 
o Postoperatively, pain scores including FACES scale by the patient and FLACC scores by the research 
assistant will be recorded immediately prior to intervention (T=0) and at end of intervention 
(T=30); FLACC score will also be recorded at the 10 minute mark (T=10). PCA use, in mcg or mg as 
appropriate, for the hour prior to intervention (T=-60-0), during intervention (T=0-30), and one 
hour after intervention is complete (T=30-90) will be recorded. Total number of minutes of 
electronic device use will be recorded. This data will be recorded by the research assistant. 
o PCA use will be converted to morphine equivalents at time of data entry. 
Descriptions of each questionnaire and scale, including total score computations: 
 

 
16
Short State-Trait Anxiety Inventory (STAI) – 6 statements (i.e., ‘I feel calm’, with 1=Not at all, 
2=Somewhat, 3=Moderately, 4=Very much). Scores 6-24, with 6 signifying no anxiety and 24 points 
signifying the highest level of anxiety. This short form of the STAI was used and validated in children 
aged 5-16 years (Schisler et al, 1998; Apell et al, 2011) 
 
FACES (Wong-Baker) Pain Rating Scale – Self-assessment scale; patients select a face that 
illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst 
(wongbakerfaces.org) 
 
FLACC (Face, Legs, Activity, Cry, Consolability) – Observer assessment scale, with 5 categories 
(i.e., ‘Face’, with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to 
constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No 
observed pain and 10=Most observed pain 
 
PHBQ-AS (Post Hospitalization Behavior Questionnaire for Ambulatory Surgery) – 11 items on a 
five-point scale (i.e., 1=Much less than before, 5=Much more than before). Total scores 11-55 (Jenkins 
et al, 2015) 
 
These are all validated scoring systems in pediatric populations. 
 
We will utilize the short STAI, as above.  
 
Units of measurement for all variables of interest: Questionnaires and scales as above. In addition, 
hours since anesthesia end to start of visit (hours), PCA use (mcg or mg, at T=-60-0, 0-30, 30-90 min; 
converted to morphine equivalents at time of data entry), patient declines (0=Yes, 1=No), total 
duration of electronic device use (min), presence of dizziness (0=No, 1=Yes), presence of nausea (0=No, 
1=Yes), anti-nausea medication requested during intervention (0=No, 1=Yes). 
 
Patient and caregiver satisfaction: Qualitative satisfaction will be documented, divided into positive 
and negative comments.  
 
5.1 
Efficacy Evaluation 
During data analysis, number of hours since anesthesia end to start of visit will be extracted from chart 
review. PCA use conversion to morphine equivalents will be performed. Pain and anxiety scores and 
PCA opioid usage will be compared between the two study arms. These data will allow us to compare 
the two study arms and evaluate for efficacy. 
 
5.2 
Pharmacokinetic Evaluation 
Not applicable 
 
5.3 
Safety Evaluations 
Safety and feasibility of VR in postsurgical populations has been proven in previous studies, some of 
which include specific spine surgery populations. As we are limiting the use of the virtual reality 
headset to 30 minutes, there is a possibility that patients may experience anxiety and/or notice an 
increase in pain following cessation of VR. As such, the patients will be permitted to freely use personal 
electronic devices without restriction, which is the standard of care at present. We feel that by doing 
this, the chance of anxiety related to complete withdrawal of electronic distraction will be low, as will 

 
17
the possibility of any adverse effects such as nausea or dizziness. The incidence of dizziness and nausea 
with the use of virtual reality is not precisely known and is not agreed upon in the literature. As it is 
mentioned in various studies as a potential side effect, we will limit the use of the virtual reality 
headsets to 30 minutes to minimize the risk. 
 
6 
STATISTICAL CONSIDERATIONS    
 
6.1 
Primary Outcomes 
Postoperative pain scores and postoperative PCA opioid usage surrounding intervention (in morphine 
equivalents).  
 
6.2 
Secondary Outcomes 
Our secondary outcomes and efficacy measures include: patient and caregiver satisfaction scores, 
presence of dizziness/nausea, time of discontinuation of VR/iPad if less than 30 minutes, and PHBQ-AS 
scores postoperatively at 48-72 hours and 7-10 days.  
 
6.3 
Statistical Methods 
All statistical estimates (e.g., means, medians, proportions, incidence rates, mean differences, 
correlations, etc.) will be tabulated along with corresponding confidence intervals (CIs). To avoid over-
reliance on p-values, the magnitudes of estimates and the corresponding confidence intervals will be 
the primary focus of the analyses. Quantitative data analysis will occur using SAS or R and will be 
conducted under the supervision of a UNC Department of Anesthesiology biostatistician along with 
other members of the UNC Department of Anesthesiology research division.  
 
We will work closely with our departmental statistician in all statistical analyses. After discussion with 
our biostatistician, we do plan to utilize a completely randomized study design. For our post-study 
analysis, we will perform analyses with and without gender stratification to assess whether gender is a 
contributing factor in opioid usage and pain scores.  
 
For Aim 1 (comparing postoperative pain and anxiety scores), the following questionnaires and scales 
with validated scoring as above will be analyzed: short STAI, FACES, FLACC, PHBQ-AS.  
 
For Aim 2 (comparing postoperative opioid usage), opioid usage will be converted into morphine 
equivalents at the time of data entry and analyzed.  
 
For Aim 3 (assessing patient and caregiver satisfaction), qualitative satisfaction will be documented, 
divided into positive and negative comments. Patient satisfaction and overall experience are 
commonly linked to pain experienced during a hospitalization, and as a result, satisfaction with the use 
of VR as a method of pain control will be one of our outcomes. 
 
We hypothesize that the use of virtual reality programs will provide superior distraction to standard of 
care and will result in improved pain scores and reduced opioid consumption after surgery. We will 
utilize two-sample t-test to compare the pain scores and opioid consumption in VR and control groups. 

 
18
We will have the p-values reported and Bonferroni correction will be used to adjust for multiple 
comparison. P-values not reaching the significance level will be deemed as inconclusive.  
 
If a value is missing, the measure will be negated for that participant, and we will have an incomplete 
data point. These incomplete data points will not be included in the analyses. This study is based on 
prior work by our group with a quite rare occurrence of not being able to collect all data points, given 
the nature of the collected data. We do not anticipate that missing values will systematically introduce 
any selection bias.  
 
6.4 
Sample Size Rationale 
We would like to present this study as a pilot study of 20 completed patients. There are approximately 
2 idiopathic scoliosis repairs per week in the pediatric population at UNC, thus we would hope to be 
able to complete the pilot portion of this study in a reasonable timeframe. Since the effect size is 
unknown at this stage, we consulted with our UNC Department of Anesthesiology statistician and 
discussed among our team.  We feel that the study design is substantially different from any published 
studies or our group’s study last year - all-comers to the PACU, versus this homogenous population 
undergoing a specific ERAS protocol with the intervention taking place on postoperative day 1. We 
would like to proceed with a pilot study that can then be used to estimate the effect size of our 
intervention on the primary outcome based on the data we collect from the pilot study (N=20). The 
pilot study will also be used to assess the feasibility of the logistics and study procedure. 
 
6.5 
Study Stopping Rules 
Any adverse events throughout the study will be reported to the PI and further safety evaluations will 
be made as necessary for the remainder of the study. If it is determined that the study exposes 
patients to more than the normal risk associated with standard of care practices, then the study will be 
stopped.  We will conduct a data analysis at the conclusion of the pilot study (N=20). Given the small 
sample size, no interim analysis of the data will be performed.  
 
7 
STUDY INTERVENTION (drug, device or other intervention details) 
The Applied VR is a lightweight mobile virtual reality headset with embedded software, creating an 
immersive experience. The Applied VR is specifically designed for medical use. The devices will be 
stored in a locked room within the Department of Anesthesiology. There will be no modifications to the 
packaging or labeling of the devices, as this may interfere with the application and functionality of the 
devices. During the intervention phase of the study, a research assistant will be monitoring the patients 
to assist with technical issues with the device, as well as to monitor for compliance and adherence. 
 
8 
STUDY INTERVENTION ADMINISTRATION (if applicable)  
Randomization and blinding procedures addressed in section 3.2. 
 
9 
SAFETY MANAGEMENT 
Any and all adverse events and any safety concerns will be reported to the PI and IRB as applicable. 
Standard of care practices will continue to be followed throughout this study, which includes serious or 
adverse event monitoring and reporting and medical emergency procedures.  

 
19
 
10 
DATA COLLECTION AND MANAGMENT  
o The research coordinator will manage all of the data through the use of a RedCap database which 
will be created prior to the start of the study. A codebook of variables will be created in consultation 
with a UNC Department of Anesthesiology biostatistician. All data entries which are missing will 
have (whenever possible) a comment associated with that data point to explain its reason for being 
missing.  
o The data collected during this study will be on hospital or School of Medicine computers with 
security features installed to protect the data. Data will be collected by a research assistant and 
will be monitored by members of this research study noted on the IRB and other members of the 
Department of Anesthesiology research division.  
o The Information Technology group within the Department of Anesthesiology provides secure 
data storage for the proposed study. Servers for the group are located in a locked office on the 
UNC campus and backed up with nightly full backups. The web server is behind a firewall and only 
known and approved site users have. This data management system meets or exceeds NIH 
security guidelines, safeguards participant data, and adheres to the Certificate of Confidentiality. 
o All data collected on paper forms will be kept in a locked file cabinet in a locked office area. 
All electronic files will be stored on the Department of Anesthesiology secured intranet without 
identifiable information. 
o Data will be stored separate from identifiable information and shared with the research team 
electronically on hospital or School of Medicine computers within the secured networks. 
 
11 
RECRUITMENT STRATEGY 
Subjects will be identified by looking at surgery schedules and type of surgery. All subjects 11-17 years 
old undergoing idiopathic scoliosis surgery will be identified and considered for this study. The subjects 
will be identified and then recruited either by phone 1-3 days in advance or in person on the day of 
their proposed surgery in the preoperative holding area.  
 
12 
CONSENT PROCESS 
The recruitment and consent process will be done either by phone with electronic consent (e-consent) 
or in person. A research assistant or member of the research team will be the recruiters for this study.  
 
E-consent will be conducted via RedCap, which has e-consent capability and knowledge tracks, with the 
ability for participants to give a physical signature and download a copy of the consent for their own 
reference. A member of the research team will call patients and their guardians 1-3 days prior to 
surgery and go through the informed consent process by phone, and will share a RedCap link so families 
can pull up the consent and go through it while on the phone with the researcher. The recruiter will be 
immediately available to answer questions by staying on the phone while participants complete the 
consent. The benefit of offering e-consent is to allow a higher enrollment of interested patients, given 
the significant time restraints on the morning of surgery that can preclude a successful completion of 
consent. The in person, day-of surgery consent option will still be offered for families who do not have 
access to a computer or prefer in person consent. 
 

 
20
For in person consents on the day of surgery, each subject will have a private room on the day of 
surgery in the preoperative area. Consent in person will be obtained in the preoperative area, in person 
and in a private room with closed doors, preventing those not involved with the study from hearing any 
private information about the study or the subjects.  
 
13 
PLANS FOR PUBLICATION 
The goal is to complete a manuscript for publication by June 1, 2021. 
 
14 
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Jenkins BN et al. Revisiting a common measure of child postoperative recovery: Development of the 
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15     APPENDIX 
 
No items for appendix at this time.