Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair

The goal of this study is to determine whether introducing VR in the immediate post-operative period following scoliosis repair can reduce perceived pain and stress in pediatric patients and in turn ultimately decrease opioid use. Based on previous studies that have been performed in other fields of pediatrics showing a decrease in pain and stress with VR use, the investigators hypothesize that VR will significantly decrease patient's reported level of pain and stress immediately following the VR session, and that patients will require less opioids during their inpatient stay as a result.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis; Scoliosis; Juvenile; Scoliosis; Adolescence
• Intervention / Treatment: Device: virtual reality

Detailed Description

This project evaluates whether providing pediatric post-operative scoliosis repair patients with a virtual reality (VR) session at specific time point following surgery can decrease pain and stress experienced and if this leads to a decrease in the use of pain medications required during the immediate recovery period. Virtual reality technology was ordered to use as a distraction tool as part of routine pediatric care for hospitalized patients. The study involves measuring pain and stress using validated scales as well as calculating opioid use in this specific pediatric post-operative scoliosis repair population. All post-operative scoliosis repair patients admitted to the inpatient pediatric floor above 7 years of age will be eligible for participation in this study. The goal is to collect data on at least 50 patients over the course of 12-18 months. Parental consent and child assent will be obtained on day 2 post-op surgery using a standardized consent and assent form, respectively. Data will be collected from the Numerical Pain Rating Scale and the State Trait Anxiety Inventory, which will be administered pre- and post-VR sessions, with the goal of comparing scores to evaluate for any decrease in pain and stress levels. Data on inpatient opioid use post-operatively will be used to compare with previous post-operative scoliosis patients to determine whether there a significant decrease in opioid use in the subjects exposed to VR. During the data collection process, results will be documented in an organized but deidentified manner.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eleny Romanos-Sirakis; Phone Number: 718-226-6435; Email: eromanos@northwell.edu

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10305
      • Recruiting
      • SIUH Northwell Health
      • Contact: Eleny Romanos-Sirakis; Phone Number: 718-226-6435; Email: eromanos@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• all pediatric patients post scoliosis repair
• age 7-21

Exclusion Criteria:

• age less than 7 years;
• history of seizures, epilepsy,
• history of motion sickness/balance problems,
• susceptibility to migraines
• currently pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - use of VR	Device: virtual reality; virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment	Use of virtual reality device exercise to reduce perception of pain. Participant will complete Numerical Pain Rating Scale.	2 years
Stress Assessment	Participant will complete and the State Trait Anxiety Inventory to assess stress	2 years

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 3, 2022
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 22-0286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes