BurnVRHNCT00260221
VRH Pain Reduction During Burn Wound Care and Physical Therapy
A study testing using VR hypnosis/distraction and audio hypnosis in people with Burn, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial summary
Using Virtual Reality Hypnosis to relief pain and anxiety for burn patients. Read more about this study
- Who is it for?
- Ages 7 to 85 years
- Conditions the study is for
- Burn
- What is being tested?
- using VR hypnosis/distraction and audio hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Nov 2011
- 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 7 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 7 years
- Able to complete subjective evaluations of pain
- English-speaking
- Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
- Able to communicate orally
Who cannot join
- Age less than 7 years
- Incapable of indicating subjective evaluation of pain
- Non-English-speaking
- Demonstrating delirium, psychosis, or Organic Brain Disorder
- Unable to communicate verbally
- Significant developmental disability
- Extreme susceptibility to motion sickness
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: Testing Interactions to Adjunctive Pain Control Techniques
Using Virtual Reality Hypnosis to relief pain and anxiety for burn patients.
Read the detailed description
The purpose of the study is to examine whether there is more effective relief of pain and anxiety during wound care procedures in burn-injured patients that are treated with Virtual Reality Hypnosis with post-hypnotic suggestion.
- Conditions
- Burn
- Being tested
- using VR hypnosis/distraction and audio hypnosis
- Keywords
- Virtual Reality Hypnosis
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using VR hypnosis/distraction and audio hypnosisBehavioural
a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm one uses Virtual Reality Hypnosis post hypnotic suggestions to reduce pain durng wound care procedures. Receives: Behavioral: using VR hypnosis/distraction and audio hypnosis |
| 2 | Experimental | Arm two uses Virtual Reality distraction that is administered at times other than during burn care procedure to control for both for attention and high technology. Receives: Behavioral: using VR hypnosis/distraction and audio hypnosis |
| 3 | Experimental | Arm three use Audio administered Hypnosis without the visual technology. Receives: Behavioral: using VR hypnosis/distraction and audio hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
we use GRS, VAS, McGill,and nurse GRS to measure the pain.
Measured: once a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startJan 2002
- Primary completionJan 2011
- Study completionNov 2011
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 BurnStudies 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, David R. Patterson, National Institute of General Medical Sciences (NIGMS)
- Investigators
- David R. Patterson, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260221
- Sponsor's protocol ID
- 19635-B
- Other IDs
- R01GM042725
- Acronym
- VRH
- Status last verified
- Mar 2011
- First submitted
- 30 Nov 2005
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Patterson DR, Tininenko JR, Schmidt AE, Sharar SR. Virtual reality hypnosis: a case report. Int J Clin Exp Hypn. 2004 Jan;52(1):27-38. doi: 10.1076/iceh.52.1.27.23925.
PubMed 14768967
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Interactions to Adjunctive Pain Control Techniques
- ClinicalTrials.gov ID
- NCT00260221
- Acronym / sponsor ID
- VRH / 19635-B
- Conditions
- Burn
- Keywords
- Virtual Reality Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2002
- Primary completion
- Jan 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Dec 2005 (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 Hypnosis to relief pain and anxiety for burn patients.
Detailed description
The purpose of the study is to examine whether there is more effective relief of pain and anxiety during wound care procedures in burn-injured patients that are treated with Virtual Reality Hypnosis with post-hypnotic suggestion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: using VR hypnosis/distraction and audio hypnosisArm one uses Virtual Reality Hypnosis post hypnotic suggestions to reduce pain durng wound care procedures. |
| 2 | Experimental | Behavioral: using VR hypnosis/distraction and audio hypnosisArm two uses Virtual Reality distraction that is administered at times other than during burn care procedure to control for both for attention and high technology. |
| 3 | Experimental | Behavioral: using VR hypnosis/distraction and audio hypnosisArm three use Audio administered Hypnosis without the visual technology. |
Who may qualify
- Ages
- 7 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 7 years
- Able to complete subjective evaluations of pain
- English-speaking
- Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
- Able to communicate orally
Key exclusion criteria (7 listed)
- Age less than 7 years
- Incapable of indicating subjective evaluation of pain
- Non-English-speaking
- Demonstrating delirium, psychosis, or Organic Brain Disorder
- Unable to communicate verbally
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 |
|---|---|---|
| using VR hypnosis/distraction and audio hypnosisa between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control | Behavioural | 1, 2, 3 |
Primary outcome
we use GRS, VAS, McGill,and nurse GRS to measure the pain.
Time frame: once a day
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 8 May 2013.
- Background: PubMed 14768967Patterson DR, Tininenko JR, Schmidt AE, Sharar SR. Virtual reality hypnosis: a case report. Int J Clin Exp Hypn. 2004 Jan;52(1):27-38. doi: 10.1076/iceh.52.1.27.23925.
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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 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 using VR hypnosis/distraction and audio hypnosis in people with 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 5 inclusion and 7 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 8 May 2013. 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?
we use GRS, VAS, McGill,and nurse GRS to measure the pain. (time frame: once a day). 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 NCT00260221, 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 8 May 2013.