A Randomized Controlled Trial of Virtual Reality for Pain Management in the Post-Operative Period Following Orthopedic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Timing of pain medication
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Virtual Reality Post Spinal Fusion
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.
Intervention: Virtual Reality (Device)
Standard of Care
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.
Outcomes
Primary Outcomes
Timing of pain medication
Time Frame: 4 days
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.
Doses of pain medication
Time Frame: 4 days
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.
Secondary Outcomes
- Length of stay(4 days)
- Pain assessment scores(4 days)
- Parents' Postoperative Pain Measure(4 days)
- Visual analogue scale(4 days)
- Faces Pain Scale-Revised(4 days)
- Time patient out of bed(4 days)
Investigators
Chantel Burkitt
Principal Investigator
Gillette Children's Specialty Healthcare