Virtual RealityPAIN-VRNCT04437173
Pain Procedures and Anxiolysis Via Distraction With Virtual Reality
A study testing Virtual Reality Headset Distraction in people with Virtual Reality and Anxiety, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non VR option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Anxiety, Pain
- What is being tested?
- Virtual Reality Headset Distraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2020to 9 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years old, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
- English speaking
- Having the ability to understand oral and written instructions
- Willing to fill out psychometric surveys.
Who cannot join
- Pregnant women
- Prisoners
- Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Interventional Pain Clinic
Sacramento, California, 95817
About this study
Official title: Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic
The purpose of this study is to evaluate the efficacy of VR distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non VR option.
- Conditions
- Virtual Reality, Anxiety, Pain
- Being tested
- Virtual Reality Headset Distraction
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Headset DistractionDevice
Patient wears a virtual reality headset during interventional pain procedure
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Arm | Experimental | Patients undergo interventional pain procedure with virtual reality distraction Receives: Device: Virtual Reality Headset Distraction |
| No Intervention Arm | No intervention | Patients undergo interventional pain procedure without virtual reality distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Score
State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety)
Measured: Immediately before procedure and immediately after procedure.
Secondary outcomes (4)
Pain Score
Pain score on an 11-point numerical rating scale (Total range 0-10 with higher scores indicating greater pain)
Measured: Immediately before procedure, during procedure, and immediately after procedure
Sedation Requirements
Amount of benzodiazepines and opioid medications given
Measured: During course of procedure
Global Impression of Change
Global Impression of Change on a 7-point scale (Lower scores indicating decline in clinical status, and higher scores indicating improvement in clinical status)
Measured: Immediately after procedure
Patient Experience Satisfaction
Experience Satisfaction on an 11-point scale (Total range 0-10 with higher scores indicating higher patient experience satisfaction)
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start7 Aug 2020
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naileshni Singh, MD, Principal investigator, University of California, DavisJohn Sun, MD, Principal investigator, University of California, DavisMichael Jung, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437173
- Sponsor's protocol ID
- 1480456
- Acronym
- PAIN-VR
- Status last verified
- Sep 2022
- First submitted
- 9 Jun 2020
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Audiovisual Distraction With Virtual Reality (VR) to Reduce Anxiety and Sedation Requirements During Pain Procedures in the Interventional Pain Clinic
- ClinicalTrials.gov ID
- NCT04437173
- Acronym / sponsor ID
- PAIN-VR / 1480456
- Conditions
- Virtual Reality, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 18 Jun 2020 (actual)
- 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 evaluate the efficacy of VR distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non VR option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Arm | Experimental | Device: Virtual Reality Headset DistractionPatients undergo interventional pain procedure with virtual reality distraction |
| No Intervention Arm | No intervention | –Patients undergo interventional pain procedure without virtual reality distraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18 years old, who are referred to University of California Davis Pain Medicine Clinic and require an interventional pain procedure
- English speaking
- Having the ability to understand oral and written instructions
- Willing to fill out psychometric surveys.
Key exclusion criteria (3 listed)
- Pregnant women
- Prisoners
- Patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment
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 Headset DistractionPatient wears a virtual reality headset during interventional pain procedure | Device | Virtual Reality Arm |
Primary outcome
Anxiety Score
Time frame: Immediately before procedure and immediately after procedure.
State-Trait Anxiety Inventory (Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety; Total range 20 to 80 with higher scores indicating greater anxiety)
4 secondary outcomes
Pain Score
Time frame: Immediately before procedure, during procedure, and immediately after procedure
Sedation Requirements
Time frame: During course of procedure
Global Impression of Change
Time frame: Immediately after procedure
Patient Experience Satisfaction
Time frame: Immediately after 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 28 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Naileshni Singh, MD principal investigator
University of California, Davis
John Sun, MD principal investigator
University of California, Davis
Michael Jung, MD principal investigator
University of California, Davis
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 Headset Distraction in people with Virtual Reality and Anxiety, run by University of California, Davis 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 3 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 28 Sep 2022. 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?
Anxiety Score (time frame: Immediately before procedure and immediately after 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 28 Sep 2022.