Virtual Reality for Post-operative Pain Management

Study Overview
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Brief Summary
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Use an RCT study design to measure pain experience, medication use, medical side effects, and length of hospital stay with and without availability of VR following spine fusion surgery

Detailed Description
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The purpose of this study is to prospectively assess the utility of virtual reality (VR) for pain and anxiety management in the post-operative period following major orthopedic surgery. While there is substantial evidence supporting the use of VR during dressing changes for burn victims, there is little known about VR use in post-surgical settings. In the proposed study, patients will be randomized to either receive VR in addition to standard of care or to receive only standard of care during their post-operative care following spinal fusion surgery for idiopathic scoliosis or neuromuscular scoliosis.

Official Title
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A Randomized Controlled Trial of Virtual Reality for Pain Management in the Post-Operative Period Following Orthopedic Surgery

Conditions
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Spinal Fusion

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is having a spinal fusion at Gillette Children's Specialty Healthcare Patient with a diagnosis of adolescent idiopathic scoliosis (AIS) or a diagnosis of neuromuscular scoliosis Exclusion Criteria: Non-English speaking parents/patients Patients with history of motion sickness Patients with epilepsy Patients with a ventricular shunt Patients with severe/profound cognitive impairments

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Post Spinal Fusion<br>Patients randomized to the VR group will have the opportunity to utilize VR during the post operative period, and will also experience VR during research visits each day following surgery. | Device: Virtual Reality<br>* Participants randomized to the VR condition will experience an an immersive guided relaxation VR experience during research visits in the post-operative period. They will also have the opportunity to choose additional VR games and relaxation experiences during their inpatient stay.<br>|
| No Intervention: Standard of Care<br>Patients randomized to the non-VR condition will experience the usual standard of care following spinal fusion surgery. This will include 15-30 minutes of movie viewing during research visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of pain medication | Timing of morphine equivalent opioids (mg/kg/day) and adjunctive medications (e.g., Tylenol, Diazepam, Propofol, Midazolam, etc.; mg/kg/day).This will be collected retrospectively from the patient medical record following the conclusion of treatment. | 4 days | 
| Doses of pain medication | Doses of morphine equivalent opioids (mg/kg/day) and adjunctive medications (e.g., Tylenol, Diazepam, Propofol, Midazolam, etc.; mg/kg/day).This will be collected retrospectively from the patient medical record following the conclusion of treatment. | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents' Postoperative Pain Measure | The Parents' Postoperative Pain Measure (PPPM-SF) is a measure of pain-related behavioral changes. The PPPM-SF is 10 question yes/no scale, covering functional interference (5 items) and pain behaviors (5 items) and asks parents to compare the child's behaviors with their typical behavior. Each score of yes is counted as 1-point, yielding a total score of 0-10 (higher scores indicating higher pain intensity). Parents will complete this measure daily until their child is discharged from the hospital. | 4 days | 
| Faces Pain Scale-Revised | The Faces Pain Scale-Revised (FPS-R) will be used to assess pain intensity in the post-operative period (for 1-6 days, depending on the length of inpatient stay) for the purposes of this study. The FPS-R will be used to assess pain intensity (faces indicating 0-10 pain scale, 0 face indicating no pain, 10 equals very much pain) right now and will be completed by the patient and parent (when present) at the beginning of each daily research visit for both the VR and non-VR groups. The VR group will complete the FPS-R again following the research facilitated VR session. For consistency purposes, parents will also be asked to report their perception of the patient's pain using the FPS-R. | 4 days | 
| Visual analogue scale | A visual analogue scale (VAS) will be used to quantify multiple aspects of the treatment experience expected to be impacted by the use of VR. The VAS will be a 10 cm 0-100 scale (0 indicating no pain, 100 indicating very much pain), will be completed once per day by both the VR and non-VR groups, and will reflect the past 24 hour period. Participants and their parents in the VR condition will complete the VAS a second time each day following the research facilitated VR experience (second VAS will reflect the past 15 minutes). The VAS will assess the following: patient anxiety; parent anxiety; patient and parent time spent thinking about pain; pain unpleasantness; average pain rating; pain rating right now; worst pain rating; least pain rating; engagement during VR (VR group only); and satisfaction with pain management. | 4 days | 
| Length of stay | Length of inpatient stay following surgery (collected from medical record) | 4 days | 
| Pain assessment scores | Nursing pain assessment scores (collected from medical record) | 4 days | 
| Time patient out of bed | Duration of time from surgery to patient out of bed and walking (collected from medical record). | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality