PainPhase 1/2NCT00409552
Human Factors Analysis in VR for Burn Treatment
A Phase 1/2 study testing Virtual Reality based distraction, VR with flat projection display and non-interactive video with head display in people with Pain and Chronic Pain, run by National Institute on Drug Abuse (NIDA).
Trial summary
A number of studies have shown that virtual reality (VR) can be used to distract patients from pain and anxiety during painful medical procedures for which medication provides inadequate relief. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic Pain
- What is being tested?
- Virtual Reality based distraction, VR with flat projection display and non-interactive video with head display
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Dec 2010
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65, male or female, any ethnicity as long as candidates can understand and read English adequately.
Who cannot join
- We will exclude participants who meet DSM-IV-TR criteria for alcohol or other substance abuse in the past year, or are currently using any recreational drugs, or taking more than 20 alcoholic drinks a week. In addition, the Beck Depression Inventory II (BDI-II) score must be less than 16, with no suicidal ideation.
About this study
Official title: Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment
A number of studies have shown that virtual reality (VR) can be used to distract patients from pain and anxiety during painful medical procedures for which medication provides inadequate relief. An inexpensive, commercially available VE could have significant impact in reducing perceived pain involved in a variety of medical procedures. The Virtual Reality Medical Center (VRMC) developed an engaging virtual world that proved to be effective in reducing reported pain ratings of participants experiencing several different forms of painful stimuli. The virtual world called Icy Cool World was found to successfully distract patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks to expand on these findings and examine the effectiveness as a pain distraction technique for a variety of acute and chronic pain etiologies. The main objective of the clinical investigation will be to expand on the findings from earlier studies and obtain a more comprehensive analysis regarding the clinical versatility of VR pain distraction.
- Conditions
- Pain, Chronic Pain
- Being tested
- Virtual Reality based distraction, VR with flat projection display, non-interactive video with head display, non-interactive video with with flat projection display
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality based distractionBehavioural
Participants will undergo virtual reality based distraction using the head display while they go through the pain process.
VR with flat projection displayBehavioural
VR with flat projection display
non-interactive video with head displayBehavioural
non-interactive video with head display
non-interactive video with with flat projection displayBehavioural
non-interactive video with with flat projection display
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Virtual Reality with head display Receives: Behavioral: Virtual Reality based distraction |
| 2 | Active comparator | Virtual Reality with flat projection display Receives: Behavioral: VR with flat projection display |
| 3 | Active comparator | non-interactive video with head display Receives: Behavioral: non-interactive video with head display |
| 4 | Active comparator | non-interactive video with flat projection display Receives: Behavioral: non-interactive video with with flat projection display |
| 5 | No intervention | No distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain rating reduction
Measured: Following each trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark D Wiederhold, MD, PhD, FACP, Principal investigator, VRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409552
- Sponsor's protocol ID
- N44DA-5-7744
- Status last verified
- Sep 2009
- First submitted
- 8 Dec 2006
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment
- ClinicalTrials.gov ID
- NCT00409552
- Acronym / sponsor ID
- N44DA-5-7744
- Conditions
- Pain, Chronic Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Dec 2006 (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.
A number of studies have shown that virtual reality (VR) can be used to distract patients from pain and anxiety during painful medical procedures for which medication provides inadequate relief. An inexpensive, commercially available VE could have significant impact in reducing perceived pain involved in a variety of medical procedures. The Virtual Reality Medical Center (VRMC) developed an engaging virtual world that proved to be effective in reducing reported pain ratings of participants experiencing several different forms of painful stimuli. The virtual world called Icy Cool World was found to successfully distract patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks to expand on these findings and examine the effectiveness as a pain distraction technique for a variety of acute and chronic pain etiologies. The main objective of the clinical investigation will be to expand on the findings from earlier studies and obtain a more comprehensive analysis regarding the clinical versatility of VR pain distraction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Virtual Reality based distractionVirtual Reality with head display |
| 2 | Active comparator | Behavioral: VR with flat projection displayVirtual Reality with flat projection display |
| 3 | Active comparator | Behavioral: non-interactive video with head displaynon-interactive video with head display |
| 4 | Active comparator | Behavioral: non-interactive video with with flat projection displaynon-interactive video with flat projection display |
| 5 | No intervention | –No distraction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65, male or female, any ethnicity as long as candidates can understand and read English adequately.
Key exclusion criteria (1 listed)
- We will exclude participants who meet DSM-IV-TR criteria for alcohol or other substance abuse in the past year, or are currently using any recreational drugs, or taking more than 20 alcoholic drinks a week. In addition, the Beck Depression Inventory II (BDI-II) score must be less than 16, with no suicidal ideation.
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 based distractionParticipants will undergo virtual reality based distraction using the head display while they go through the pain process. | Behavioural | 1 |
| VR with flat projection displayVR with flat projection display | Behavioural | 2 |
| non-interactive video with head displaynon-interactive video with head display | Behavioural | 3 |
| non-interactive video with with flat projection displaynon-interactive video with with flat projection display | Behavioural | 4 |
Primary outcome
Pain rating reduction
Time frame: Following each trial
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 12 Jan 2017.
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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.
Mark D Wiederhold, MD, PhD, FACP principal investigator
VRMC
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Virtual Reality based distraction, VR with flat projection display and non-interactive video with head display in people with Pain and Chronic Pain, run by National Institute on Drug Abuse (NIDA).
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 1 inclusion and 1 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 rating reduction (time frame: Following each trial). 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 12 Jan 2017.