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OpenTrials
Completed

NCT Number: NCT04545229

VR for Pain Management During Adult Burn Dressing Change

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.

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Key information

Conditions

Pain Burns Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR-based Pain Alleviation Tool (VR-PAT)

Other

Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.

Primary outcomes

  1. 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

  1. Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay.

    Time frame: Each day during inpatient hospital stays up to 7 days.

    Opioid pain medication use (converted to morphine equivalent dose), obtained through patient medical administration records. This data will be used as morphine equivalent dose per day, total morphine-equivalent dose during hospital stay, and average morphine-equivalent dose among active VR group, passive VR group, and standard care group in comparison.

Other outcomes

  1. Patient VR experience

    Time frame: Subjective experience during burn dressing change, on average lasting 15-45 minutes.

    Patient subjective virtual reality experience using a survey questionnaire (7 items about participant's experience with VR during burning dressing changes). Questions are a mixture of yes/no and a 100 Visual Analog Scale with 0 being "Not at All" and 100 being "Very Much"

  2. Nurse reported feasibility of VR in clinical burn wound care

    Time frame: Subjective observation of patient's utilization of VR during burn dressing change, on average lasting 15-45 minutes.

    Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from "not at all" to "very easy".

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • Ohio State University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2020
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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