PainNCT00701571
Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain
A study testing Virtual Reality distraction in people with Pain, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to compare the analgesic efficacy of three different types of video/audio distraction in normal volunteers subjected to carefully controlled and non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of a lumbar puncture. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Virtual Reality distraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men and women
- 18-21y, 40-60y, or older than 60y
Who cannot join
- a predisposition to motion sickness
- unusual sensitivity or lack of sensitivity to pain
- chronic pain
- peripheral neuropathy
- sensitive skin
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the analgesic efficacy of three different types of video/audio distraction in normal volunteers subjected to carefully controlled and non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of a lumbar puncture. Two of the distraction techniques include immersive virtual reality (VR). The most efficacious distraction technique will be used in a subsequent clinical study in cancer patients.
- Conditions
- Pain
- Being tested
- Virtual Reality distraction
- Keywords
- Virtual Reality, Oncology, Lumbar puncture
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality distractionProcedure or surgery
Virtual Reality involves the participant wearing a helmet with sight and sound. the visual provided is a type of immersive video game, the game used is "Snow World". In some cases the participant will be exposed to 3D representation of the game, and in other cases a lower tech version with less immersive qualities.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3 cohorts: 18-21 years, 40-60 years, and older than 60 years Receives: Procedure: Virtual Reality distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare positional techniques and differing types of VR presentation (immersive vs. low tech). We will also compare age cohorts (18-21, 40-60, and older than 60 years).
Measured: upon completion of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionDec 2009
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Seattle Cancer and Aging Program
- Responsible party
- Principal investigator, Chris Hoffer, University of Washington
- Investigators
- Samuel R Sharar, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701571
- Sponsor's protocol ID
- 26745
- Other IDs
- 1R21CA107256-01A1, P20CA103728-04
- Status last verified
- Sep 2011
- First submitted
- 17 Jun 2008
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain
- ClinicalTrials.gov ID
- NCT00701571
- Acronym / sponsor ID
- 26745
- Conditions
- Pain
- Keywords
- Virtual Reality, Oncology, Lumbar puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Seattle Cancer and Aging Program
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Jun 2008 (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.
The purpose of this study is to compare the analgesic efficacy of three different types of video/audio distraction in normal volunteers subjected to carefully controlled and non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of a lumbar puncture. Two of the distraction techniques include immersive virtual reality (VR). The most efficacious distraction technique will be used in a subsequent clinical study in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Virtual Reality distraction3 cohorts: 18-21 years, 40-60 years, and older than 60 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy men and women
- 18-21y, 40-60y, or older than 60y
Key exclusion criteria (5 listed)
- a predisposition to motion sickness
- unusual sensitivity or lack of sensitivity to pain
- chronic pain
- peripheral neuropathy
- sensitive skin
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 distractionVirtual Reality involves the participant wearing a helmet with sight and sound. the visual provided is a type of immersive video game, the game used is "Snow World". In some cases the participant will be exposed to 3D representation of the game, and in other cases a lower tech version with less immersive qualities. | Procedure or surgery | 1 |
Primary outcome
To compare positional techniques and differing types of VR presentation (immersive vs. low tech). We will also compare age cohorts (18-21, 40-60, and older than 60 years).
Time frame: upon completion of data collection
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 Sep 2011.
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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.
Samuel R Sharar, MD 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 Virtual Reality distraction 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 2 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 13 Sep 2011. 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?
To compare positional techniques and differing types of VR presentation (immersive vs. low tech). We will also compare age cohorts (18-21, 40-60, and older than 60 years). (time frame: upon completion of data collection). 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 Sep 2011.