PainNCT04545229
VR for Pain Management During Adult Burn Dressing Change
A study testing VR-based Pain Alleviation Tool (VR-PAT) in people with Pain and Burns, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- VR-based Pain Alleviation Tool (VR-PAT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 24 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Virtual Reality Distraction to Reduce Opioid Pain Medication Use 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.
Read the 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).
- Being tested
- VR-based Pain Alleviation Tool (VR-PAT)
- Medical subject headings
- Pain, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active VR-PAT | Experimental | Active VR-based Pain Alleviation Tool (VR-PAT) group played smart phone VR-PAT during the burn dressing changes. Receives: Other: VR-based Pain Alleviation Tool (VR-PAT) |
| 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. Receives: Other: VR-based Pain Alleviation Tool (VR-PAT) |
| Standard Care Control | No intervention | Standard care control group used regular distraction such as background music or no distraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self-reported pain
Patient self-reported pain using the 100mm Visual Analog Scale (VAS), 0 (min)-100(max), higher score for worse outcome.
Measured: During burn dressing changes
Secondary outcomes (1)
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.
Measured: Each day during inpatient hospital stays up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Feb 2019
- Primary completion24 Nov 2019
- Study completion24 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-group RCT
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Henry Xiang, Nationwide Children's Hospital
- Investigators
- Henry Xiang, MD, MPH, PhD, Principal investigator, The Ohio State University/Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545229
- Sponsor's protocol ID
- 2018H0257
- Status last verified
- Apr 2024
- First submitted
- 1 Sep 2020
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not allowed to share patient medical records data.
Publications
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.
PubMed 37747893
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Distraction to Reduce Opioid Pain Medication Use During Adult Burn Dressing Change
- ClinicalTrials.gov ID
- NCT04545229
- Acronym / sponsor ID
- 2018H0257
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 24 Nov 2019 (actual)
- Study completion
- 24 Nov 2019 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-group RCT
| Arm | Type | Receives |
|---|---|---|
| Active VR-PAT | Experimental | Other: VR-based Pain Alleviation Tool (VR-PAT)Active VR-based Pain Alleviation Tool (VR-PAT) group played smart phone VR-PAT during the burn dressing changes. |
| Passive VR-PAT | Experimental | Other: VR-based Pain Alleviation Tool (VR-PAT)Passive VR-based Pain Alleviation Tool (VR-PAT) group watched smart phone VR-PAT games without interaction during the burn dressing changes. |
| Standard Care Control | No intervention | –Standard care control group used regular distraction such as background music or no distraction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-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. | Other | Active VR-PAT, Passive VR-PAT |
Primary outcome
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.
1 secondary outcome
Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay.
Time frame: Each day during inpatient hospital stays up to 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Results publication: PubMed 37747893Armstrong 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.
- Individual participant dataSharing planned: No. We are not allowed to share patient medical records data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Xiang, MD, MPH, PhD principal investigator
The Ohio State University/Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-based Pain Alleviation Tool (VR-PAT) in people with Pain and Burns, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient self-reported pain (time frame: During burn dressing changes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04545229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.