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Clinical Trials/NCT04545229
NCT04545229
Completed
Not Applicable

Virtual Reality Distraction to Reduce Opioid Pain Medication Use During Adult Burn Dressing Change

Nationwide Children's Hospital1 site in 1 country14 target enrollmentFebruary 1, 2019
ConditionsPainBurns

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Nationwide Children's Hospital
Enrollment
14
Locations
1
Primary Endpoint
Patient self-reported pain
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

A randomized controlled trial to evaluate the efficacy of the VR-based Pain Alleviation Tool (VR-PAT) in reducing opioid pain medication use during adult burn dressing changes.

Detailed Description

A pilot three group gender-balanced randomized clinical trial (RCT) among adult burn patients (18 years old or above) at OSU Medical Center Inpatient Burn Program. The intervention group will receive VR-PAT as a distraction tool during the dressing change procedure (active VR group) while the comparison groups will receive either a comparable passive VR distraction tool that uses the same hardware and visual/audio features, but requires no active interaction (Control Group 1), or no distraction at all (Control Group 2).

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
November 24, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Henry Xiang

Professor and Center Director

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult burn patient age 18-70
  • First admission for acute burn requiring dressing change
  • First admission for burn injury
  • Using Opioids for dressing changes
  • Burn is ≤ 4 days post burn

Exclusion Criteria

  • Severe burn(s) on the face/head preventing utilization of VR
  • Cognitive/motor impairment preventing valid administration of study measures
  • Unable to communicate in English
  • Prisoners and patients who were pregnant
  • Patients admitted to the ICU

Outcomes

Primary Outcomes

Patient self-reported pain

Time Frame: During burn dressing changes

Patient self-reported pain using the 100mm Visual Analog Scale (VAS), 0 (min)-100(max), higher score for worse outcome.

Secondary Outcomes

  • Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay.(Each day during inpatient hospital stays up to 7 days.)

Study Sites (1)

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