Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Sponsor: Connecticut Children's Medical Center

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PROTOCOL TITLE: Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis 
Patient Population  
 
PROTOCOL VERSION DATE:  2.12.24 
 
PRINCIPAL INVESTIGATOR: David Hersh, MD  
CO-INVESTIGATOR: Robert Astur, PhD 
DEPARTMENT: Neurosurgery 
DEPARTMENT: Psychological Sciences 
INSTITUTION: Connecticut Children’s 
INSTITUTION: University of Connecticut  
PHONE: 860-545-8373 
PHONE:  
EMAIL: dhersh@connecticutchildens.org  
EMAIL: robert.astur@uconn.edu 
 
CO-INVESTIGATOR: Mark Lee, MD 
CO-INVESTIGATOR: William Zempsky, MD 
MPH 
DEPARTMENT: Orthopedic Surgery 
DEPARTMENT: Pain and Palliative Medicine 
INSTITUTION: Connecticut Children’s 
INSTITUTION: Connecticut Children’s 
PHONE: 
PHONE:  
EMAIL: mlee01@connecticutchildrens.org 
E-MAIL: Wzempsk@connecticutchildrens.org 
 
 
STUDY COORDINATOR: Cameron King 
 
 
DEPARTMENT:  Neurosurgery 
 
INSTITUTION: Connecticut Children’s 
 
PHONE: 
 
EMAIL: CKing02@connecticutchildrens.org 
 
 
STUDY TEAM MEMBER: Prabhath Mannam  
STUDY TEAM MEMBER: Patrick Halloran 
DEPARTMENT: School of Medicine  
DEPARTMENT: School of Medicine 
INSTITUTION: University of Connecticut  
INSTITUTION: University of Connecticut  
PHONE: 860-709-2371 
PHONE: 860.861.9948 
EMAIL: pmannam@uchc.edu  
EMAIL: phalloran@uchc.edu 
 
STUDY TEAM MEMBER: Oluwadamilola Egbewole 
DEPARTMENT:  Neurosurgery 
 
INSTITUTION: Connecticut Children’s 
 
PHONE: 
 
EMAIL: OEgbewole@connecticutchildrens.org 
 
 
 

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Table of Contents 
 
Background/Introduction 
Research Question 
Primary and Secondary Aims 
Outcome Definitions/Data Points Collected 
Study Design 
Target Population 
Inclusion and Exclusion Criteria 
Sampling Method and Recruitment Process 
Study Retention and Withdrawal 
Study Procedures 
Sample Size Justification 
Feasibility, Accrual, and Duration of Accrual 
Study Limitations 
Data Analysis 
Administrative Organization, Roles and Responsibilities 
Use of Study Results 
Study Budget 
References 
Appendices

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Background/Introduction 
 
Scoliosis is broadly defined as deviation of the normal vertical alignment of the spinal column. 
Scoliosis is typically classified as congenital, neuromuscular, syndromic, or idiopathic and may be treated 
with observation, bracing, or surgical correction, depending on the severity and the clinical status of the 
patient.[1] Idiopathic scoliosis represents the most common pediatric subtype and has a prevalence of 0.5 
– 5.2%, with an operative rate ranging from 3.9 – 9.8 operations per 100,000 members of the general 
population.[2-4] Post-operative pain following the surgical correction of pediatric scoliosis is inevitable 
and must be well managed to achieve the goals of patient comfort, early mobilization, and early discharge. 
As a result of the short- and long-term adverse effects of opioid use in the pediatric population, many 
practices are adopting multimodal pain management strategies to reduce the reliance on opioid analgesia.[5, 
6] 
 
 
Virtual reality (VR) has been extensively studied in regards to its ability to reduce peri-procedural 
pain and anxiety in a pediatric population.7 Non-pharmacological methods of distraction are a well-
established method of pain control. Virtual reality, by providing a more interactive and immersive 
experience, has the potential to out-perform other distraction techniques. However, the specific impact of 
VR following scoliosis surgery has yet to be assessed.8  At Connecticut Children’s, patients undergo 
multimodal pain management following scoliosis correction, including narcotics, muscle relaxants, anti-
inflammatories, and gabapentin. Patients are also expected to participate with physical therapy daily. In the 
present study, we intend to investigate the effect of VR on subjective post-operative pain, total inpatient 
narcotic administration, and mobilization with physical therapy. 
 
Research Question 
 
Does implementation of VR reduce pain, reduce total narcotic administration, and increase 
mobilization with physical therapy in the immediate post-operative period following spinal deformity 
surgery in the pediatric population? 
 
Primary and Secondary Aims 
 
Primary Aim(s):  
• 
To determine if virtual reality (VR) reduces the subjective perception of pain for pediatric patients 
in the acute post-operative period (until discharge) following spinal deformity surgery.  
o Hypothesis: The mean self-reported pain level using a 10-point numeric pain scale will be 
a minimum of 1 point lower in patients receiving VR compared to those in the control 
group.  
 
Secondary Aims:  
• 
To determine if VR reduces the total amount of inpatient narcotic use in the acute post-operative 
period (until discharge) following spinal deformity surgery.  
o Hypothesis: Patients receiving VR will have reduced total inpatient narcotic administration 
during their hospital stay compared to those in the control group. 
• 
To determine if VR can facilitate earlier mobilization following spinal deformity surgery.  

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o Hypothesis: Patients receiving VR will participate in a fewer number of physical therapy 
(PT) sessions prior to receiving clearance for discharge by PT staff.  
 
Outcome Definitions/Data Points Collected 
Primary Outcome: 
Pain will be measured through the 10-point numeric pain scale self-reported by the patient 
(patient’s will be between 13-18 years of age).  
Secondary Outcomes: 
• 
Mobilization will be assessed by the number of PT sessions prior to receiving clearance for 
discharge by PT staff. 
• 
Patient post-operative gross motor activity level will be measured via wearable Fitbit 
• 
Opioid utilization will be assessed by calculating the total inpatient dose of opioids administered 
(as documented in the EMR) during the post-operative period.  
• 
Side effects from virtual therapy, including headaches, vertigo, and nausea 
 
Data collected:  
• 
Patient demographics 
o Age, Sex, Race, Language, Ethnicity  
• 
Patient Past Medical History 
• 
Patient medication/drug history (prescription and recreational) 
• 
Prior experience with VR 
• 
Surgical details 
o # of spinal levels involved in fusion  
o Duration of surgery 
o Surgical blood loss 
o Need for transfusion 
o Complications 
• 
Radiographic imaging 
• 
 10-point numeric pain scale ratingsPhysical Therapy notes 
o Number of sessions prior to discharge clearance, timing of sessions, duration of each 
session, comments from each session,  
• 
EPIC Medication History  
• 
Length of stay  
• 
Timing and duration of virtual reality sessions 
• 
Side effects from virtual therapy sessions 
o Seizures  
o Loss of awareness 
o Headaches 
o Vertigo 
o Nausea 
o Eye strain / blurred or double vision 
o Eye or muscle twitching 

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o Involuntary movements 
o Dizziness and lightheadedness 
o Disorientation 
o Impaired balance and hand-eye coordination 
o Excessive sweating 
o Increased salivation 
o Drowsiness 
o Fatigue 
o Motion sickness 
o Skin irritation 
o Low temperature burns 
o Hair loss 
o  
Study Design 
Mixed methods with a prospective cohort and retrospective chart review.  
Target Population  
Pediatric patients (ages 13-18) undergoing corrective scoliosis surgery at Connecticut Children’s over a 
span of 12 months (03/01/24-03/01/25). 
Inclusion/Exclusion Criteria 
Inclusion: 
 
Prospective:  
• 
All pediatric patients (ages 13-18) at Connecticut Children’s undergoing surgical correction for 
idiopathic scoliosis over a span of 12 months (03/01/24-03/01/25) will be eligible for inclusion in 
the prospective arm.  
 
Retrospective: 
• 
All pediatric patients (ages 13-18) at Connecticut Children’s that underwent surgical correction for 
idiopathic scoliosis in the retrospective time frame (03/01/19 - 03/01/24) will be eligible for 
inclusion in the retrospective arm.  
 
Exclusion: 
• 
History of seizures 
• 
Cognitive developmental delay precluding participation in VR 
• 
Head or neck surgery that does not allow a head-mounted display to be worn safely 
• 
Chronic pain requiring the daily use of opioids for more than 2 weeks prior to the procedure 
• 
Non-English speakers 
• 
Side effects during screening 
• 
Patients with vagal nerve stimulators, cardiac pacemakers, and/or cochlear implants that may 
receive interference from the VR device 

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Sampling Method/Recruitment Process 
Prospective cohort sample:  
All pediatric patients (ages 13-18) undergoing corrective scoliosis surgery at Connecticut Children’s over 
a span of 12 months (03/01/24-03/01/25) will be approached by a study team member during the pre-
operative stage with information and consent documentation about the study. If the patient acknowledges 
that they are interested and would like more information, then the study team member will complete the 
formal consent and HIPAA process with the patient and family. This will take place in a private setting, 
and the patient/family will be given ample time to reach the consent and have any questions answered. As 
a part of the consent and HIPAA, patients will consent to the study procedures as well as the research study 
team accessing their medical record for data collection. Each patient’s MRN will be entered into a secure 
password protected Excel enrollment log and be given a subject identification number for de-identification. 
During the consenting procedure, the patient will utilize the VR device for 5 minutes to screen for side 
effects and become accommodated to the device. In the event that the patient experiences side effects during 
this 5-minute period, they will be excluded from the study.  
 
Retrospective chart review sample: 
The retrospective chart review is intended to be used as a historical control to the prospective arm of the 
study. All patients in the retrospective time frame (02/01/19 - 02/01/24) will be identified using CPT codes 
(fusion codes: 22800, 22802, 22804 and instrumentation codes: 22842, 22843, 22844) as well as ICD-10 
Code M41.* from Slicer Dicer. These patient’s charts will be verified by a study team member to ensure 
they meet inclusion criteria, and then they will be entered into a using a secure password protected Excel 
enrollment log. Each patient’s MRN will be recorded into the enrollment log and will be given a subject 
identification number for de-identification. Patients in this cohort will not be approached for consent as we 
will not collect identifiable information and only their deidentified medical record will be in review. It is 
also likely that some patients are no longer clinically active at Connecticut Children’s, and therefore we 
would not be able to contact these patients for consent.  
Study Retention/Withdrawal 
Prospective Cohort: 
All patients will be admitted after surgery. It is anticipated that some subjects may opt to not continue with 
VR and withdraw from the study. Participants will be told that they may withdraw from the study at any 
time by reaching out to the PI, Dr. David Hersh, or the study coordinator, Cameron King. Withdrawing 
from the study will not affect patient care. A patient may also decline participation for a VR session, but 
choose not to withdraw from the entire study. If a patient declines three consecutive VR sessions, then they 
will be withdrawn from the study. If a patient withdraws, any data already collected will be made de-
identifiable and no further information will be collected. These patients will not be included in downstream 
analyses.  
 
Retrospective Cohort:  
These patients will  not be approached for consent and therefore will not be able to withdraw from the 
study.  
Study Procedures 

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Due to the limited number of corrective surgeries for scoliosis in a given year, a true randomized control 
trial cannot be performed. As such, a prospective cohort will be used – all patients undergoing surgery 
during the study period will be offered VR and will be assessed for pain, opioid usage, and mobilization 
following surgery. These outcome measures will be compared to data identified from a retrospective chart 
review of children receiving the same surgery but without an additional VR-intervention, thus serving as a 
historical control.  
 
Prospective Arm: 
After consenting to the study, the following baseline assessments will be performed and collected from the 
patient during the pre-operative stage: pain level and vital signs (heart rate, blood pressure, O2 saturation). 
Starting on postoperative day 1, the prospective cohort will begin receiving VR. These sessions will occur 
twice daily, starting 30 minutes prior to the patient’s scheduled PT appointments, and will be facilitated by 
a study team member. At the beginning of the session, a study team member will visit the patient’s room 
and set up the virtual reality device. A study team member will try to stay with the patient for the duration 
of the VR session, but in the event that they are unavailable to do so, a member of the nursing team, physical 
therapy team, or a parent will remain with the participant. As such, there will always be an adult in close 
proximity to the participant while they use the VR device. The duration of the session will last 
approximately 20 minutes and will utilize a low physical load VR experience (underwater or space 
exploration). The goal of the VR experience is to immerse the patient a setting that gives the experience of 
decreased weight bearing load to decrease their post-operative pain. The VR screen will display a simulated 
environment, such as an underwater exploration, in which the participant can interact with floating marine 
life and vegetation. If the patient experiences side effects or would like a break during the VR intervention, 
they can inform a study team member and remove the VR device. They are permitted to place the VR 
device back on and continue the session when they feel comfortable to do so. A session will be considered 
“failed” if more than 50% of the session is spent not using the VR device. During the post-operative stage, 
the above outcome measures will be reassessed daily immediately before and after VR and also following 
the PT session. After the patient is discharged, the total number of PT sessions and total administered opiods 
will be collected from the patient’s medical charts. In addition to pain, opiod usage, and mobility data from 
the study, the following information will be collected from the patient charts and entered into REDCap: 
demographics, degree of scoliosis, surgical details, PT notes, pain medication regimens, associated pain 
scales, and relevant follow up notes. As the VR device will be shared between users, the device will be 
sanitized with UV LEDs by Cleanbox prior to the transfer between patients. 
 
Retrospective Arm: 
Eligible patients verified for the retrospective chart review will be entered into a secure Excel enrollment 
log and be deidentified by using a subject identification number. The MRN and subject ID will be entered 
into a linking file that will be password protected and only accessible to authorized study personnel. The 
following information will be collected from the patient charts: demographics, degree of scoliosis, surgical 
details, PT notes, pain medication regimens, associated pain scales, and relevant follow up notes. These 
data will be entered into REDCap in a de-identified manner and will only be accessible to authorized study 
team members.  
 
Sample Size Justification 

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This study will utilize a convenience sample of patients presenting to Connecticut Children’s for a scoliosis 
surgery within the study timeframe.  
 
Feasibility, Accrual, and Duration of Accrual 
Accrual will occur over a 12 month period (03/01/24 - 03/01/25). Approximately 60-80 patients undergo a 
surgical procedure for the correction of scoliosis annually at Connecticut Children’s. We estimate ~40% 
will decline to participate, therefore we anticipate approximately 35-50 patients being included in the 
prospective arm of study. For the retrospective arm of the study, we approximate to include 350 patients 
for chart review.  
 
Study Limitations 
This study is limited in that we are only assessing the utility of VR to reduce pain in a specific patient 
population (pediatric patients undergoing surgical correction of scoliosis), at a specific time (the immediate 
post-operative period), at a single institution (Connecticut Children’s), and within a relatively small sample 
size,  which limits the generalizability of the study to apply to other patient populations. This study is also 
limited in that it utilizes a retrospective chart review as a historical control. By collecting data 
retrospectively, it is likely that the study team will encounter missing variables and will not be able to 
categorize pain as accurately as they would be able to in a prospective or true randomized control trial study 
designs. 
Data Analysis 
• 
Intention to treat analysis 
• 
A biostatistician will assist in analysis 
• 
Descriptive statistics (frequency, percentage, mean, standard deviation, median, and interquartile 
range) will be utilized to describe the two groups (VR and control) 
• 
Fisher’s Exact test, independent t-tests, and Wilcoxon Rank Sum tests will be used for univariate 
analysis to compare demographics between the two groups (VR and control) 
• 
Pain outcome: 
o Univariate analysis using independent t-tests or Wilcoxon rank sum tests will be used to 
compare the daily mean pain scales 
• 
Opioid utilization outcome 
o Univariate analysis using independent t-tests or Wilcoxon rank sum tests will be used to 
compare the total inpatient dose of opioids administered 
Administrative Organization/Roles and Responsibilities 
• 
Principal Investigator - David Hersh, MD - Connecticut Children’s Division of Neurosurgery 
• 
Co-Principal Investigator – Robert Astur, PhD – UConn Department of Psychological Sciences 
• 
Co-Principal Investigator – Mark Lee, MD – Connecticut Children’s Division of Orthopedic 
Surgery 
• 
Co-Principal Investigator – William Zempsky, MD MPH – Connecticut Children’s Division of 
Pain and Palliative Medicine 
• 
Student Coordinators and Responsibilities: 
o Cameron King – Study Coordinator 
▪ 
Study Design 

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▪ 
Data quality 
▪ 
Data analysis  
▪ 
Project management 
▪ 
Manuscript drafting 
o Prabhath Mannam – Medical student 
▪ 
Study design 
▪ 
Study Procedures 
▪ 
Data analysis 
▪ 
Manuscript drafting  
o Patrick Halloran – Medical Student 
▪ 
Study Design 
▪ 
Study procedures 
▪ 
Data analysis 
▪ 
Manuscript drafting 
 
 
 
Use of Study Results 
The data generated from this study will be used to re-evaluate the postoperative pain management pathway 
for pediatric patients in the post-operative period following spinal deformity surgery. These data will also 
be used for presentations / publications.  
 
Study Budget  
 
 
References: 
 
1. 
Janicki, J.A. and B. Alman, Scoliosis: Review of diagnosis and treatment. Paediatr Child 
Health, 2007. 12(9): p. 771-6. 

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2. 
Al-Mohrej, O.A., S.S. Aldakhil, M.A. Al-Rabiah, and A.M. Al-Rabiah, Surgical treatment 
of adolescent idiopathic scoliosis: Complications. Ann Med Surg (Lond), 2020. 52: p. 19-
23. 
3. 
Sung, S., et al., Incidence and Surgery Rate of Idiopathic Scoliosis: A Nationwide 
Database Study. Int J Environ Res Public Health, 2021. 18(15). 
4. 
Tsirikos, A.I., S.B. Roberts, and E. Bhatti, Incidence of spinal deformity surgery in a 
national health service from 2005 to 2018: an analysis of 2,205 children and 
adolescents. Bone Jt Open, 2020. 1(3): p. 19-28. 
5. 
Matson, K.L., et al., Opioid Use in Children. J Pediatr Pharmacol Ther, 2019. 24(1): p. 
72-75. 
6. 
Shah, S.A., et al., Current Trends in Pediatric Spine Deformity Surgery: Multimodal Pain 
Management and Rapid Recovery. Global Spine J, 2020. 10(3): p. 346-352. 
 
 
 

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Appendices 
 
Appendix A – Data Collection Tool 
 
Appendix B – FACES pain scales