TraumaVRHTraumaNCT00739076
Pain Control After Trauma
A study testing Virtual Reality in people with Trauma, run by University of Washington at 1 site in United States.
Trial summary
Using Virtual Reality as a form of pain control for trauma patients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 12 years
- Compliant and able to complete questionnaires
- Hospitalization for internal injuries requiring a laparotomy or for orthopedic injuries (closed long bone or calcaneus fractures).
- A minimum of 3 days hospitalization
- No history of psychiatric (DSM-IV-R Axis I) disorder
- Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
Show all 10Show fewer
- Able to communicate verbally
- Able to take oral medications
- Baseline pain level of >=5/10
- English-speaking
Who cannot join
- Age less than 12 years
- Not capable of indicating pain intensity
- Not capable of filling out study measures
- Hospitalization of less than 3 days
- Evidence of traumatic brain injury
- History of psychiatric (DSM-IV-R Axis I) disorder as evidenced in the admitting RN and MD admission notes.
Show all 16Show fewer
- Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems.
- Unable to communicate orally.
- Unable to take oral medications
- History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment
- Receiving prophylaxis for alcohol or drug withdrawal
- Developmental disability
- Mini-mental status score of greater than 20 in patients older than 80 years or suspected of cognitive deficits
- 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
Using Virtual Reality as a form of pain control for trauma patients.
Read the detailed description
The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' pain from trauma.
- Conditions
- Trauma
- Being tested
- Virtual Reality
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
Using Virtual Reality for pain control
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Virtual Reality Hypnosis Receives: Behavioral: Virtual Reality |
| 2 | Experimental | Virtual Reality Distraction Receives: Behavioral: Virtual Reality |
| 3 | Experimental | Standard treatment. Receives: Behavioral: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Anxiety
Measured: up to 3 times a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, David 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
- NCT00739076
- Sponsor's protocol ID
- 30359-G
- Other IDs
- R01GM042725-09A1
- Acronym
- VRHTrauma
- Status last verified
- Apr 2015
- First submitted
- 20 Aug 2008
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control After Trauma
- ClinicalTrials.gov ID
- NCT00739076
- Acronym / sponsor ID
- VRHTrauma / 30359-G
- Conditions
- Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of General Medical Sciences (NIGMS)
- Study start
- Aug 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Aug 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.
Using Virtual Reality as a form of pain control for trauma patients.
Detailed description
The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' pain from trauma.
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: Virtual RealityVirtual Reality Hypnosis |
| 2 | Experimental | Behavioral: Virtual RealityVirtual Reality Distraction |
| 3 | Experimental | Behavioral: Virtual RealityStandard treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age greater than or equal to 12 years
- Compliant and able to complete questionnaires
- Hospitalization for internal injuries requiring a laparotomy or for orthopedic injuries (closed long bone or calcaneus fractures).
- A minimum of 3 days hospitalization
- No history of psychiatric (DSM-IV-R Axis I) disorder
Key exclusion criteria (16 listed)
- Age less than 12 years
- Not capable of indicating pain intensity
- Not capable of filling out study measures
- Hospitalization of less than 3 days
- Evidence of traumatic brain injury
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 RealityUsing Virtual Reality for pain control | Behavioural | 1, 2, 3 |
Primary outcome
Pain and Anxiety
Time frame: up to 3 times 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 3 Apr 2015.
Related trials for Trauma
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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 Virtual Reality in people with Trauma, 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 10 inclusion and 16 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 3 Apr 2015. 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 and Anxiety (time frame: up to 3 times a day). 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 3 Apr 2015.