BurnVRD/PedsNCT00993889
Virtual Reality Analgesia During Pediatric Physical Therapy
A study testing VR during Physical Therapy, VR Background Pain and NO VR in people with Burn, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial summary
We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient). Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Burn
- What is being tested?
- VR during Physical Therapy, VR Background Pain and NO VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Apr 2017
- 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 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age greater than or equal to 8 years up to 20 yrs old
- Compliant and able to complete subject evaluation
- A minimum of 3 days of physical therapy, one physical therapy session per day
- No history of psychiatric (DSM-IV-R Axis I) or developmental disorder that would interfere with decisional capacity
- Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder that would interfere with decisional capacity
- Able to communicate verbally
- Able to take oral medications
- English-speaking
Who cannot join
- - Age less than 8 years, or greater than 20 years.
- Not capable of indicating pain intensity
- Not capable of filling out study measures
- Hospitalization of fewer 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, if interfering with decisional capacity
Show all 16Show fewer
- Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems that would interfere with decisional capacity
- Unable to communicate verbally
- Unable to take oral medications
- History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment that would interfere with treatment or decisional capacity
- Receiving prophylaxis for alcohol or drug withdrawal
- Developmental disability that would interfere with decisional capacity
- Face/head/neck injuries preventing helmet use
- Non-English-speaking
- Extreme susceptibility to motion sickness
- Seizure history
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104-2499
About this study
We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).
Read the detailed description
This study is done in a hospital for inpatients pediatrics. By randomization some subjects will immersive Virtual Reality (VR) during a painful procedure on daily basis up to 10 days to see whether this will reduce the pain and anxiety.
- Conditions
- Burn
- Being tested
- VR during Physical Therapy, VR Background Pain, NO VR
- Keywords
- Virtual Reality Peds
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR during Physical TherapyBehavioural
Virtual Reality will be performed during a painful physical therapy procedure.
VR Background PainBehavioural
Virtual Reality is used at anytime during the day for the background pain, not during physical therapy.
NO VRBehavioural
The subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure.
| Study group | Role | What they receive |
|---|---|---|
| VR during Physical Therapy | Experimental | The subject will receive virtual reality during painful physical therapy sessions. Receives: Behavioral: VR during Physical Therapy |
| VR background pain | Experimental | The subjects receives virtual reality, not during a physical therapy procedure, another time of the day for background pain. Receives: Behavioral: VR Background Pain |
| No VR | Experimental | The subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure. Receives: Behavioral: NO VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and anxiety
Measured: pre and post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)
- Sponsor type
- US National Institutes of Health
- 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
- NCT00993889
- Sponsor's protocol ID
- 36154-C
- Acronym
- VRD/Peds
- Status last verified
- Mar 2019
- First submitted
- 13 Oct 2009
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Analgesia During Pediatric Physical Therapy
- ClinicalTrials.gov ID
- NCT00993889
- Acronym / sponsor ID
- VRD/Peds / 36154-C
- Conditions
- Burn
- Keywords
- Virtual Reality Peds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Study start
- May 2009
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 14 Oct 2009 (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.
We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).
Detailed description
This study is done in a hospital for inpatients pediatrics. By randomization some subjects will immersive Virtual Reality (VR) during a painful procedure on daily basis up to 10 days to see whether this will reduce the pain and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR during Physical Therapy | Experimental | Behavioral: VR during Physical TherapyThe subject will receive virtual reality during painful physical therapy sessions. |
| VR background pain | Experimental | Behavioral: VR Background PainThe subjects receives virtual reality, not during a physical therapy procedure, another time of the day for background pain. |
| No VR | Experimental | Behavioral: NO VRThe subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure. |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age greater than or equal to 8 years up to 20 yrs old
- Compliant and able to complete subject evaluation
- A minimum of 3 days of physical therapy, one physical therapy session per day
- No history of psychiatric (DSM-IV-R Axis I) or developmental disorder that would interfere with decisional capacity
- Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder that would interfere with decisional capacity
Key exclusion criteria (16 listed)
- - Age less than 8 years, or greater than 20 years.
- Not capable of indicating pain intensity
- Not capable of filling out study measures
- Hospitalization of fewer 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 |
|---|---|---|
| VR during Physical TherapyVirtual Reality will be performed during a painful physical therapy procedure. | Behavioural | VR during Physical Therapy |
| VR Background PainVirtual Reality is used at anytime during the day for the background pain, not during physical therapy. | Behavioural | VR background pain |
| NO VRThe subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure. | Behavioural | No VR |
Primary outcome
Pain and anxiety
Time frame: pre and post procedure
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 Mar 2019.
Related trials for Burn
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
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 VR during Physical Therapy, VR Background Pain and NO VR 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 8 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 13 Mar 2019. 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: pre and post procedure). 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 Mar 2019.