PainH2OWCNCT02646787
Virtual Reality Water Friendly Wound Care
A study testing Active Virtual Reality and Passive Virtual Reality in people with Pain, run by University of Washington at 1 site in United States.
Trial summary
Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Active Virtual Reality and Passive Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jun 2020
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 8 years
- Compliant and able to complete questionnaires
- No history of psychiatric disorder
- Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
- Able to communicate verbally
- English-speaking
Who cannot join
- Age less than 8 years
- Not capable of indicating pain intensity
- Not capable of filling out study measures
- Evidence of traumatic brain injury
- History of psychiatric disorder
- Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
Show all 13Show fewer
- Unable to communicate orally
- Receiving prophylaxis for alcohol or drug withdrawal
- Developmental disability
- Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
- Non-English Speaking
- Extreme susceptibility to motion sickness
- Seizure history
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington; Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Water Friendly Virtual Reality for Burns
Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.
Read the detailed description
Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.The aim of this study is to conduct a randomized controlled trial of Virtual Reality as a means to reduce pain during wound care in patients hospitalized for their burn injuries at Harborview Medical Center Burn Center, and Shriners Hospitals for Children in Galveston, Texas.
- Conditions
- Pain
- Being tested
- Active Virtual Reality, Passive Virtual Reality
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Virtual RealityBehavioural
The subject is actively engaged in using virtual reality during a painful burn wound care session.
Passive Virtual RealityBehavioural
The subject is passively engaged in using virtual reality during a painful burn wound care session.
| Study group | Role | What they receive |
|---|---|---|
| Active Virtual Reality | Experimental | The subject is actively engaged in using virtual reality during a painful burn wound care session. Receives: Behavioral: Active Virtual Reality |
| Passive Virtual Reality | Experimental | The subject is passively engaged in using virtual reality during a painful burn wound care session. Receives: Behavioral: Passive Virtual Reality |
| Control | No intervention | No intervention during the subject's standard wound care session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain. Pain is measured one time prior a painful burn wound care session, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.
Measured: one time for the duration of one minute before the wound care
Pain. Pain is measured one time after a painful burn wound, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.
Measured: one time for the duration of one minute after the wound care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), University of Texas
- Responsible party
- Principal investigator, David Patterson, University of Washington
- Investigators
- David R Patterson, Ph.D., Principal investigator, University of WashingtonDavid R Patterson, Ph. D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646787
- Sponsor's protocol ID
- STUDY00002594
- Other IDs
- R01GM042725
- Acronym
- H2OWC
- Status last verified
- Jun 2020
- First submitted
- 15 Dec 2015
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Friendly Virtual Reality for Burns
- ClinicalTrials.gov ID
- NCT02646787
- Acronym / sponsor ID
- H2OWC / STUDY00002594
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), University of Texas
- Study start
- Oct 2015
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 6 Jan 2016 (estimated)
- 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.
Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.
Detailed description
Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.The aim of this study is to conduct a randomized controlled trial of Virtual Reality as a means to reduce pain during wound care in patients hospitalized for their burn injuries at Harborview Medical Center Burn Center, and Shriners Hospitals for Children in Galveston, Texas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Virtual Reality | Experimental | Behavioral: Active Virtual RealityThe subject is actively engaged in using virtual reality during a painful burn wound care session. |
| Passive Virtual Reality | Experimental | Behavioral: Passive Virtual RealityThe subject is passively engaged in using virtual reality during a painful burn wound care session. |
| Control | No intervention | –No intervention during the subject's standard wound care session |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 8 years
- Compliant and able to complete questionnaires
- No history of psychiatric disorder
- Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
- Able to communicate verbally
Key exclusion criteria (13 listed)
- Age less than 8 years
- Not capable of indicating pain intensity
- Not capable of filling out study measures
- Evidence of traumatic brain injury
- History of psychiatric disorder
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 |
|---|---|---|
| Active Virtual RealityThe subject is actively engaged in using virtual reality during a painful burn wound care session. | Behavioural | Active Virtual Reality |
| Passive Virtual RealityThe subject is passively engaged in using virtual reality during a painful burn wound care session. | Behavioural | Passive Virtual Reality |
Primary outcome
Pain. Pain is measured one time prior a painful burn wound care session, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.
Time frame: one time for the duration of one minute before the wound care
Pain. Pain is measured one time after a painful burn wound, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.
Time frame: one time for the duration of one minute after the wound care
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 9 Jun 2020.
Related trials for Pain
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
RecruitingPhase 3
Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
Recruiting
Anterior Nerves of the Knee Block Versus Femoral Nerve Block for Knee Arthroscopy
Postoperative Pain, Knee Arthroscopy
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.
David R Patterson, Ph.D. principal investigator
University of Washington
David R Patterson, Ph. D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Virtual Reality and Passive Virtual Reality in people with Pain, run by University of Washington 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 6 inclusion and 13 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 9 Jun 2020. 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?
Pain. Pain is measured one time prior a painful burn wound care session, by asking the subjects about their pain level, using a questionnaire called graphic rating scale. (time frame: one time for the duration of one minute before the wound care). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2020.