Clinical trial NCT03584776: Virtual Reality for Post-operative Pain Management
Official title: A Randomized Controlled Trial of Virtual Reality for Pain Management in the Post-Operative Period Following Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Fusion
Keywords: Virtual reality
Lead sponsor: Gillette Children's Specialty Healthcare
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Timing of pain medication
timeFrame: 4 days
measure: Doses of pain medication
timeFrame: 4 days
Secondary outcomes:
measure: Parents' Postoperative Pain Measure
timeFrame: 4 days
measure: Faces Pain Scale-Revised
timeFrame: 4 days
measure: Visual analogue scale
timeFrame: 4 days
measure: Length of stay
timeFrame: 4 days
measure: Pain assessment scores
timeFrame: 4 days
measure: Time patient out of bed
timeFrame: 4 days
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: Gillette Children's Specialty Healthcare
name: Chantel Barney, PhD
role: PRINCIPAL_INVESTIGATOR
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