Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2022
CompletedStudy Start
First participant enrolled
September 3, 2022
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedSeptember 19, 2024
September 1, 2024
2.1 years
September 3, 2022
September 10, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Intervention - use of VR
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- all pediatric patients post scoliosis repair
- age 7-21
You may not qualify if:
- age less than 7 years;
- history of seizures, epilepsy,
- history of motion sickness/balance problems,
- susceptibility to migraines
- currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
SIUH Northwell Health
Staten Island, New York, 10305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2022
First Posted
June 5, 2023
Study Start
September 3, 2022
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share