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Clinical Trials/NCT03584776
NCT03584776
Active, not recruiting
Not Applicable

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

Gillette Children's Specialty Healthcare1 site in 1 country48 target enrollmentJanuary 30, 2019
ConditionsSpinal Fusion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Fusion
Sponsor
Gillette Children's Specialty Healthcare
Enrollment
48
Locations
1
Primary Endpoint
Timing of pain medication
Status
Active, not recruiting
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2019
End Date
December 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chantel Burkitt

Principal Investigator

Gillette Children's Specialty Healthcare

Eligibility Criteria

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

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

  • Pain assessment scores(4 days)
  • Length of stay(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)

Study Sites (1)

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