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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888038
• Other study ID #: 22-0286
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2023
• Source: Northwell Health
• Contact: Eleny Romanos-Sirakis
• Phone: 718-226-6435
• Email: eromanos[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis; Adolescence
• Scoliosis; Juvenile

Intervention

Device:
• virtual reality
virtual reality

Locations

Country	Name	City	State
United States	SIUH Northwell Health	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

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