Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
Primary Purpose
Scoliosis; Juvenile, Scoliosis; Adolescence, Scoliosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
virtual reality
Sponsored by
About this trial
This is an interventional supportive care trial for Scoliosis; Juvenile
Eligibility Criteria
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
Sites / Locations
- SIUH Northwell HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention - use of VR
Arm Description
Outcomes
Primary Outcome Measures
Pain Assessment
Use of virtual reality device exercise to reduce perception of pain. Participant will complete Numerical Pain Rating Scale.
Stress Assessment
Participant will complete and the State Trait Anxiety Inventory to assess stress
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05888038
Brief Title
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
Official Title
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis; Juvenile, Scoliosis; Adolescence, Scoliosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention - use of VR
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
virtual reality
Intervention Description
virtual reality
Primary Outcome Measure Information:
Title
Pain Assessment
Description
Use of virtual reality device exercise to reduce perception of pain. Participant will complete Numerical Pain Rating Scale.
Time Frame
2 years
Title
Stress Assessment
Description
Participant will complete and the State Trait Anxiety Inventory to assess stress
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleny Romanos-Sirakis
Phone
718-226-6435
Email
eromanos@northwell.edu
Facility Information:
Facility Name
SIUH Northwell Health
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleny Romanos-Sirakis
Phone
718-226-6435
Email
eromanos@northwell.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
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