PainVRH2ONCT02427659
VR High Tech Pain Control Burn Wound Care
A study testing Virtual Reality Distraction and Audio (sound of nature) in people with Pain and Burn, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial summary
Using virtual reality as a form of distraction for pain during wound care. Virtual reality involves looking into a set of goggles and then moving through a computer-simulated world. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Virtual Reality Distraction and Audio (sound of nature)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 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 18 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: High Technology Pain Control During Burn Wound Care
Using virtual reality as a form of distraction for pain during wound care. Virtual reality involves looking into a set of goggles and then moving through a computer-simulated world.
Read the detailed description
This study has three different groups. Patients will be randomly assigned to one of three groups (two treatments and one control). Treatment for Group 1 is Virtual Reality Distraction during wound care. Group 2 will listen to an audio recording called "Sounds of Nature". Group 3 will be the control group.
Subjects in all three groups will receive the following questionnaires:
Graphic Rating Scale McGill Short-Form pain questionnaire Sullivan Catastrophization scale (only on Day 1/Baseline) The Nurse GRS
- Being tested
- Virtual Reality Distraction, Audio (sound of nature), Control standard nurse wound care
- Keywords
- VRD, Virtual Reality as Distraction during Procedure, Burn Wound Care
- Medical subject headings
- Pain, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionBehavioural
Also called VRD
The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
Audio (sound of nature)Behavioural
The subjects will listen to an audio recording called "Sounds of Nature" during their wound care.
Control standard nurse wound careBehavioural
The subjects will receive their standard care during wound care. The nurse will be doing the wound care.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Distraction | Other | The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care. Receives: Behavioral: Virtual Reality Distraction |
| Audio (sounds of nature) | Other | The subjects will listen to an audio recording called "Sounds of Nature" during their wound care. The nurse will be doing the wound care. Receives: Behavioral: Audio (sound of nature) |
| control standard nurse wound care | Other | The subjects will receive their standard care during wound care. The nurse will be doing the wound care. Receives: Behavioral: Control standard nurse wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Pain" as measured by McGill Short Form Pain Questionnaire
Pain is being measured
Measured: up to an hour
"Pain" as measured by Nurse Graphic Rating Scale
Pain is being measured.
Measured: up to 3 hours
"Pain and anxiety" as measured by Graphic Rating Scale
Pain and anxiety is being measured
Measured: up to an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startNov 2011
- Primary completionNov 2016
- Study completionAug 2017
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, David R. Patterson, National Institute of General Medical Sciences (NIGMS)
- Investigators
- David R. Patterson, Ph.D., Principal investigator, University fo Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427659
- Sponsor's protocol ID
- 41673
- Acronym
- VRH2O
- Status last verified
- Mar 2019
- First submitted
- 31 Mar 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Technology Pain Control During Burn Wound Care
- ClinicalTrials.gov ID
- NCT02427659
- Acronym / sponsor ID
- VRH2O / 41673
- Keywords
- VRD, Virtual Reality as Distraction during Procedure, Burn Wound Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Study start
- Nov 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 28 Apr 2015 (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 for pain during wound care. Virtual reality involves looking into a set of goggles and then moving through a computer-simulated world.
Detailed description
This study has three different groups. Patients will be randomly assigned to one of three groups (two treatments and one control). Treatment for Group 1 is Virtual Reality Distraction during wound care. Group 2 will listen to an audio recording called "Sounds of Nature". Group 3 will be the control group.
Subjects in all three groups will receive the following questionnaires:
Graphic Rating Scale McGill Short-Form pain questionnaire Sullivan Catastrophization scale (only on Day 1/Baseline) The Nurse GRS
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Distraction | Other | Behavioral: Virtual Reality DistractionThe subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care. |
| Audio (sounds of nature) | Other | Behavioral: Audio (sound of nature)The subjects will listen to an audio recording called "Sounds of Nature" during their wound care. The nurse will be doing the wound care. |
| control standard nurse wound care | Other | Behavioral: Control standard nurse wound careThe subjects will receive their standard care during wound care. The nurse will be doing the wound care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 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 18 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 |
|---|---|---|
| Virtual Reality DistractionAlso: VRDThe subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care. | Behavioural | Virtual Reality Distraction |
| Audio (sound of nature)The subjects will listen to an audio recording called "Sounds of Nature" during their wound care. | Behavioural | Audio (sounds of nature) |
| Control standard nurse wound careThe subjects will receive their standard care during wound care. The nurse will be doing the wound care. | Behavioural | control standard nurse wound care |
Primary outcome
"Pain" as measured by McGill Short Form Pain Questionnaire
Time frame: up to an hour
Pain is being measured
"Pain" as measured by Nurse Graphic Rating Scale
Time frame: up to 3 hours
Pain is being measured.
"Pain and anxiety" as measured by Graphic Rating Scale
Time frame: up to an hour
Pain and anxiety is being measured
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 13 Mar 2019.
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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.
David R. Patterson, Ph.D. principal investigator
University fo 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 Virtual Reality Distraction and Audio (sound of nature) in people with Pain and Burn, run by National Institute of General Medical Sciences (NIGMS) 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 13 Mar 2019. 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" as measured by McGill Short Form Pain Questionnaire (time frame: up to an hour). The study lists 3 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 13 Mar 2019.