Trauma/Injury ProblemVROTNCT02100163
Virtual Reality Pain Control Orthopedic Trauma
A study testing Virtual Reality Hypnosis, Audio Hypnosis and Standard treatment in people with Trauma/Injury Problem, run by National Institute of General Medical Sciences (NIGMS) at 1 site in United States.
Trial summary
The treatment of postoperative pain after severe trauma is poorly understood, and it can lead to chronic pain, opiate drug addiction and elevated health care costs. The proposed project will be a randomized controlled trial to evaluate an innovative methodology for delivering clinical hypnosis (virtual reality… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trauma/Injury Problem
- What is being tested?
- Virtual Reality Hypnosis, Audio Hypnosis and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 24 Jun 2018
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Compliant and able to complete questionnaires
- English speaking
- Hospitalization for trauma orthopedic injuries
- No history of psychiatric disorder
- Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
- Able to communicate verbally
- 18 years of age or older
Who cannot join
- Not capable of filling out study measures
- Evidence of a traumatic brain injury or any other
- Cognitive deficits that would impact decisional capacity to consent for the
- study or complete measures
- History of psychiatric disorder as evidenced in the RN and MD admission notes
- Unable to communicate verbally
Show all 10Show fewer
- Extreme susceptibility to motion sickness
- Seizure history
- Non-English speaking
- In isolation for infections such as Clostridium difficile
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Controling Pain After Orthopedic Trauma
The treatment of postoperative pain after severe trauma is poorly understood, and it can lead to chronic pain, opiate drug addiction and elevated health care costs. The proposed project will be a randomized controlled trial to evaluate an innovative methodology for delivering clinical hypnosis (virtual reality hypnosis) for pain control as well as a more time-honored delivery system that uses audio recordings. The goal will be to reduce postoperative pain in a sample of patients hospitalized for the care of severe orthopedic trauma and other types trauma. This proposal will test innovative and low-risk approaches to reducing postoperative trauma pain that are designed to reduce pain, anxiety and other complications after surgery. The findings have the potential not only to reduce pain and suffering in patients who have suffered severe trauma but could be applicable to the millions of people who have surgery every year. Reducing addictive opiate-based medication and health care costs are both potential outcomes from this project.
- Conditions
- Trauma/Injury Problem
- Being tested
- Virtual Reality Hypnosis, Audio Hypnosis, Standard treatment
- Keywords
- Ortho trauma. Virtual Reality. Pain. Anxiety
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HypnosisBehavioural
Also called VRH
The patient receives virtual reality hypnosis daily.
Audio HypnosisBehavioural
Patient will listen to an Audio Hypnosis recording daily.
Standard treatmentOther
Also called Tere are no interventions
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Hypnosis | Experimental | The patient receives VRH daily. Receives: Behavioral: Virtual Reality Hypnosis |
| Audio Hypnosis | Experimental | The patient receives Audio Hypnosis daily. Receives: Behavioral: Audio Hypnosis |
| Standard Treatment | Experimental | The patient receives the standard treatment. This is a control group and there are no interventions. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graphic Rating Scale (GRS) pain and anxiety Questionnaire
Measures pain and anxiety
Measured: up to 10 days
Secondary outcomes (1)
Tellegen Absorption Scale
consists of 34 true-false items that examines hypnotic susceptibility in individuals
Measured: 1 day (Once in the hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion24 Jun 2018
- Study completion24 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma/Injury ProblemStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 211 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
- NCT02100163
- Sponsor's protocol ID
- 43654-J/001500
- Acronym
- VROT
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rhodes JR, Corlett CE, Jensen MP, Patterson DR. Immersive Virtual Reality to Reduce Pain and Anxiety in Individuals Undergoing Orthopedic Surgery for Acute Trauma: A Randomized Clinical Trial. Int J Clin Exp Hypn. 2025 Jan-Mar;73(1):106-122. doi: 10.1080/00207144.2024.2433270. Epub 2024 Dec 11.
PubMed 39661916
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
- Controling Pain After Orthopedic Trauma
- ClinicalTrials.gov ID
- NCT02100163
- Acronym / sponsor ID
- VROT / 43654-J/001500
- Conditions
- Trauma/Injury Problem
- Keywords
- Ortho trauma. Virtual Reality. Pain. Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- National Institute of General Medical Sciences (NIGMS)US National Institutes of Health
- Study start
- Mar 2014 (actual)
- Primary completion
- 24 Jun 2018 (actual)
- Study completion
- 24 Jun 2018 (actual)
- First posted
- 31 Mar 2014 (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 treatment of postoperative pain after severe trauma is poorly understood, and it can lead to chronic pain, opiate drug addiction and elevated health care costs. The proposed project will be a randomized controlled trial to evaluate an innovative methodology for delivering clinical hypnosis (virtual reality hypnosis) for pain control as well as a more time-honored delivery system that uses audio recordings. The goal will be to reduce postoperative pain in a sample of patients hospitalized for the care of severe orthopedic trauma and other types trauma. This proposal will test innovative and low-risk approaches to reducing postoperative trauma pain that are designed to reduce pain, anxiety and other complications after surgery. The findings have the potential not only to reduce pain and suffering in patients who have suffered severe trauma but could be applicable to the millions of people who have surgery every year. Reducing addictive opiate-based medication and health care costs are both potential outcomes from this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Hypnosis | Experimental | Behavioral: Virtual Reality HypnosisThe patient receives VRH daily. |
| Audio Hypnosis | Experimental | Behavioral: Audio HypnosisThe patient receives Audio Hypnosis daily. |
| Standard Treatment | Experimental | Other: Standard treatmentThe patient receives the standard treatment. This is a control group and there are no interventions. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Compliant and able to complete questionnaires
- English speaking
- Hospitalization for trauma orthopedic injuries
- No history of psychiatric disorder
- Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
Key exclusion criteria (10 listed)
- Not capable of filling out study measures
- Evidence of a traumatic brain injury or any other
- Cognitive deficits that would impact decisional capacity to consent for the
- study or complete measures
- History of psychiatric disorder as evidenced in the RN and MD admission notes
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 HypnosisAlso: VRHThe patient receives virtual reality hypnosis daily. | Behavioural | Virtual Reality Hypnosis |
| Audio HypnosisPatient will listen to an Audio Hypnosis recording daily. | Behavioural | Audio Hypnosis |
| Standard treatmentAlso: Tere are no interventions | Other | Standard Treatment |
Primary outcome
Graphic Rating Scale (GRS) pain and anxiety Questionnaire
Time frame: up to 10 days
Measures pain and anxiety
1 secondary outcome
Tellegen Absorption Scale
Time frame: 1 day (Once in the hospital)
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.
- Derived from this study: PubMed 39661916Rhodes JR, Corlett CE, Jensen MP, Patterson DR. Immersive Virtual Reality to Reduce Pain and Anxiety in Individuals Undergoing Orthopedic Surgery for Acute Trauma: A Randomized Clinical Trial. Int J Clin Exp Hypn. 2025 Jan-Mar;73(1):106-122. doi: 10.1080/00207144.2024.2433270. Epub 2024 Dec 11.
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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.
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 Hypnosis, Audio Hypnosis and Standard treatment in people with Trauma/Injury Problem, 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 7 inclusion and 10 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?
Graphic Rating Scale (GRS) pain and anxiety Questionnaire (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100163, which also lists 1 linked publication.
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.