Burns, Pain
Conditions
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).
Interventions
OTHERVR-based Pain Alleviation Tool (VR-PAT)
Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.
Sponsors
Ohio State University
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
In this pilot study, no masking was implemented.
Intervention model description
Three-group RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Adult burn patient age 18-70 2. First admission for acute burn requiring dressing change 3. First admission for burn injury 4. Using Opioids for dressing changes 5. Burn is ≤ 4 days post burn
Exclusion criteria
1. Severe burn(s) on the face/head preventing utilization of VR 2. Cognitive/motor impairment preventing valid administration of study measures 3. Unable to communicate in English 4. Prisoners and patients who were pregnant 5. Patients admitted to the ICU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient self-reported pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay. | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient VR experience | 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 |
| Nurse reported feasibility of VR in clinical burn wound care | 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. |
Countries
United States
Outcome results
None listed