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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05888038
Enrollment
50
Registered
2023-06-05
Start date
2022-09-03
Completion date
2024-09-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis, Scoliosis; Adolescence, Scoliosis; Juvenile

Brief 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.

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.

Interventions

DEVICEvirtual reality

virtual reality

Sponsors

Northwell Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Assessment2 yearsUse of virtual reality device exercise to reduce perception of pain. Participant will complete Numerical Pain Rating Scale.
Stress Assessment2 yearsParticipant will complete and the State Trait Anxiety Inventory to assess stress

Countries

United States

Contacts

Primary ContactEleny Romanos-Sirakis
eromanos@northwell.edu718-226-6435

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026