Virtual Reality TherapyNCT01840774
Modifying Virtual Reality Analgesia With Low-Dose Pain Medication
A study of Virtual Reality Therapy, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2014
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and females between the age of 18 and 60 years
- Ability to communicate orally
- Ability to read and understand English
- Body Mass Index between 20-35
Who cannot join
- Women who are pregnant, trying to become pregnant, or who are breastfeeding
- History of alcohol or substance abuse
- Major medical illness; including history of migraine headaches, seizures, brain injury, or peripheral neuropathy
- Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids
- Predisposition to severe motion sickness
- Unusual sensitivity or lack of sensitivity to pain
- Urine toxicology positive for opioids or benzodiazepines
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Christine Hoffer, BA, 206-616-3075, hoffer@uw.edu
About this study
The purpose of this study is to determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. Research participants will play two versions of the Virtual Reality based video game "Snow World" and be given thermal and electrical stimulus. Each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.
- Conditions
- Virtual Reality Therapy
- Being tested
- Low-dose pain medication (Ketalar) and saline placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose pain medication (Ketalar) and saline placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low-dose pain medication | Active comparator | 80min IV infusion of a low-dose pain medication Receives: Drug: Low-dose pain medication (Ketalar) and saline placebo |
| saline placebo | Placebo comparator | 80min IV infusion of a saline placebo Receives: Drug: Low-dose pain medication (Ketalar) and saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World.
Measured: Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual Reality TherapyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Sam Sharar, University of Washington
- Investigators
- Samuel Sharar, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840774
- Sponsor's protocol ID
- 43929
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2013
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying Virtual Reality Analgesia With Low-Dose Pain Medication
- ClinicalTrials.gov ID
- NCT01840774
- Acronym / sponsor ID
- 43929
- Conditions
- Virtual Reality Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 26 Apr 2013 (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 determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications.
Detailed description
This is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. Research participants will play two versions of the Virtual Reality based video game "Snow World" and be given thermal and electrical stimulus. Each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose pain medication | Active comparator | Drug: Low-dose pain medication (Ketalar) and saline placebo80min IV infusion of a low-dose pain medication |
| saline placebo | Placebo comparator | Drug: Low-dose pain medication (Ketalar) and saline placebo80min IV infusion of a saline placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and females between the age of 18 and 60 years
- Ability to communicate orally
- Ability to read and understand English
- Body Mass Index between 20-35
Key exclusion criteria (7 listed)
- Women who are pregnant, trying to become pregnant, or who are breastfeeding
- History of alcohol or substance abuse
- Major medical illness; including history of migraine headaches, seizures, brain injury, or peripheral neuropathy
- Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids
- Predisposition to severe motion sickness
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 |
|---|---|---|
| Low-dose pain medication (Ketalar) and saline placebo | Drug | Low-dose pain medication, saline placebo |
Primary outcome
Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World.
Time frame: Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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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 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 of Virtual Reality Therapy, 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 4 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: status not confirmed, as of the sponsor's last update on 26 Apr 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Hoffer, BA (206-616-3075, hoffer@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World. (time frame: Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us.). 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 26 Apr 2013.