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| Name | Class |
|---|---|
| Ohio State University | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active VR-PAT | Experimental | Active VR-based Pain Alleviation Tool (VR-PAT) group played smart phone VR-PAT during the burn dressing changes. |
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| Passive VR-PAT | Experimental | Passive VR-based Pain Alleviation Tool (VR-PAT) group watched smart phone VR-PAT games without interaction during the burn dressing changes. |
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| Standard Care Control | No Intervention | Standard care control group used regular distraction such as background music or no distraction. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-reported pain | Patient self-reported pain using the 100mm Visual Analog Scale (VAS), 0 (min)-100(max), higher score for worse outcome. | During burn dressing changes |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient VR experience | 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" | Subjective experience during burn dressing change, on average lasting 15-45 minutes. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Xiang, MD, MPH, PhD | The Ohio State University/Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37747893 | Result | Armstrong M, Coffey R, Luna J, Xiang H. Pilot randomized clinical trial of virtual reality pain management during adult burn dressing changes: Lessons learned. PLOS Digit Health. 2023 Sep 25;2(9):e0000231. doi: 10.1371/journal.pdig.0000231. eCollection 2023 Sep. |
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We are not allowed to share patient medical records data.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D002056 | Burns |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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Three-group RCT
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In this pilot study, no masking was implemented.
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| Each day during inpatient hospital stays up to 7 days. |
| Nurse reported feasibility of VR in clinical burn wound care | Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from "not at all" to "very easy". | Subjective observation of patient's utilization of VR during burn dressing change, on average lasting 15-45 minutes. |