Procedural PainNCT07779083
Virtual Reality (VR) Audiovisual Distraction to Reduce Pain and Anxiety for Prone Pain Procedures
A study testing Virtual Reality (VR) Audiovisual Distraction in people with Procedural Pain and Procedural Anxiety, run by University of California, Davis at 1 site in United States.
Trial summary
This study evaluates whether virtual reality (VR) audiovisual distraction can reduce pain, anxiety, and the need for pain and anxiety medications during prone pain procedures, compared to standard care alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Pain, Procedural Anxiety
- What is being tested?
- Virtual Reality (VR) Audiovisual Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years old or older
- Male and female gender
- Referred to UC Davis Pain Medicine Clinic and require a prone pain procedure
- English speaking and with the ability to understand oral and written instructions
Who cannot join
- Pregnant women
- Prisoners
- Patients who have high risk of motion sickness
- Seizure disorder
- Visual/hearing impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UC Davis Pain Clinic
Sacramento, California, 95817
Michael J. Jung, MD, MBA, 916-734-6824, mijjung@health.ucdavis.edu
Michael J. Jung, MD, MBA
About this study
This study evaluates whether virtual reality (VR) audiovisual distraction can reduce pain, anxiety, and the need for pain and anxiety medications during prone pain procedures, compared to standard care alone. The trial design is a two-arm, parallel assignment, randomized controlled trial at a single site, the UC Davis Pain Medicine Clinic. Patients will be randomized in a 1:1 allocation to the intervention (commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support) vs control (standard medical care). The primary outcome will be a composite outcome analyzed using the Win Ratio method comparing opioid/sedative medication use, intra-procedural pain scores, and intra-procedural anxiety scores between groups. Approximately 230 people at UC Davis are expected to participate (Up to 20 patients for the preliminary run-in period to acclimatize research and clinical staff and 210 total for the randomized clinical trial). Each participant's involvement consists of one visit, estimated at 30 minutes.
- Conditions
- Procedural Pain, Procedural Anxiety
- Being tested
- Virtual Reality (VR) Audiovisual Distraction
- Keywords
- Virtual Reality, Pain, Anxiety, Prone Pain Procedure, Audiovisual Distraction
- Medical subject headings
- Pain, Procedural, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) Audiovisual DistractionBehavioural
Using a VR headset with an ergonomic cushion/support which will display a calming audiovisual experience during the procedure. The VR headset is a commercially available Meta Quest 3.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Audiovisual Distraction | Experimental | Participants received a commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support in addition to standard medical care based on the independent treating physician. Receives: Behavioral: Virtual Reality (VR) Audiovisual Distraction |
| Standard Care | No intervention | Standard medical care based on the independent treating physician, which includes standard care such as numbing and sedating medicines without audiovisual distraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome Using Win Ratio Method (Opioid/Sedative Use, Intra-procedural Pain Score, and Intra-procedural Anxiety Score)
The primary outcome is a composite analyzed using the Win Ratio method. Each intervention patient will be compared with each control patient. Pairs are evaluated in priority order: opioid/sedative use, intra-procedural pain score, then intra-procedural anxiety score. A patient who received no opioids/sedatives wins over one who did; if tied, the lower pain score wins; if still tied, the lower anxiety score wins. If all three measures are identical, the pair is a tie. The Win Ratio is calculated as total intervention wins divided by total control wins. A Win Ratio >1 indicates superiority of VR; a 95% confidence interval will be calculated. Pain and anxiety are measured using the Numeric Rating Scale (NRS), from 0 (none) to 10 (worst possible), with higher scores indicating worse outcomes.
Measured: During the procedure, approximately 30 minutes
Secondary outcomes (8)
Opioid and Sedative Medication Use
Whether opioid and/or sedative medications were administered during the prone pain procedure.
Measured: During the procedure, approximately 30 minutes
Intra-procedural Pain Score on the Numeric Rating Scale (NRS)
Pain assessed using the Numeric Rating Scale (NRS). Scores range from 0 (no pain) to 10 (worst possible pain). Higher scores indicate a worse outcome.
Measured: During the procedure, approximately 30 minutes
Intra-procedural Anxiety Score on the Numeric Rating Scale (NRS)
Anxiety assessed using the Numeric Rating Scale (NRS). Scores range from 0 (no anxiety) to 10 (worst possible anxiety). Higher scores indicate a worse outcome.
Measured: During the procedure, approximately 30 minutes
Pain Intensity on the Patient-Reported Outcomes Measurement Information System Pain Intensity Short Form-3a (PROMIS Pain Intensity SF-3a)
PROMIS Pain Intensity Short Form-3a. Scores range from 3 to 15. Higher scores indicate a worse outcome.
Measured: Pre-procedure and post-procedure, approximately 30 minutes
Anxiety on the State-Trait Anxiety Inventory 6-item (STAI-6)
State-Trait Anxiety Inventory 6-item (STAI-6). Scores range from 4 to 24. Higher scores indicate a worse outcome.
Measured: Pre-procedure and post-procedure, approximately 30 minutes
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change. Scores range from 1 to 7. Higher scores indicate a better outcome.
Measured: Post-procedure, approximately 30 minutes
Patient Experience Satisfaction
Patient Experience Satisfaction. Scores range from 0 to 10. Higher scores indicate a better outcome.
Measured: Post-procedure, approximately 30 minutes
Virtual Reality Experience Feedback
Virtual Reality experience feedback (immersion, comfort, side effects, usability, task load). No score range or directionality as it is a free response section.
Measured: Post-procedure, approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies 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
- Model description
- Two-arm, parallel assignment, randomized controlled trial. Patients will be randomized in a 1:1 allocation to the intervention (VR headset with audiovisual calming nature scene and ergonomic cushion/support) vs control (standard medical care).
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Jihnouk Jung, University of California, Davis
- Investigators
- Michael J. Jung, MD, MBA, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779083
- Sponsor's protocol ID
- 2349412
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality (VR) Audiovisual Distraction to Reduce Pain and Anxiety for Prone Pain Procedures
- ClinicalTrials.gov ID
- NCT07779083
- Acronym / sponsor ID
- 2349412
- Conditions
- Procedural Pain, Procedural Anxiety
- Keywords
- Virtual Reality, Pain, Anxiety, Prone Pain Procedure, Audiovisual Distraction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Aug 2026 (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.
This study evaluates whether virtual reality (VR) audiovisual distraction can reduce pain, anxiety, and the need for pain and anxiety medications during prone pain procedures, compared to standard care alone. The trial design is a two-arm, parallel assignment, randomized controlled trial at a single site, the UC Davis Pain Medicine Clinic. Patients will be randomized in a 1:1 allocation to the intervention (commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support) vs control (standard medical care). The primary outcome will be a composite outcome analyzed using the Win Ratio method comparing opioid/sedative medication use, intra-procedural pain scores, and intra-procedural anxiety scores between groups. Approximately 230 people at UC Davis are expected to participate (Up to 20 patients for the preliminary run-in period to acclimatize research and clinical staff and 210 total for the randomized clinical trial). Each participant's involvement consists of one visit, estimated at 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel assignment, randomized controlled trial. Patients will be randomized in a 1:1 allocation to the intervention (VR headset with audiovisual calming nature scene and ergonomic cushion/support) vs control (standard medical care).
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Audiovisual Distraction | Experimental | Behavioral: Virtual Reality (VR) Audiovisual DistractionParticipants received a commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support in addition to standard medical care based on the independent treating physician. |
| Standard Care | No intervention | –Standard medical care based on the independent treating physician, which includes standard care such as numbing and sedating medicines without audiovisual 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 18 years old or older
- Male and female gender
- Referred to UC Davis Pain Medicine Clinic and require a prone pain procedure
- English speaking and with the ability to understand oral and written instructions
Key exclusion criteria (5 listed)
- Pregnant women
- Prisoners
- Patients who have high risk of motion sickness
- Seizure disorder
- 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 (VR) Audiovisual DistractionUsing a VR headset with an ergonomic cushion/support which will display a calming audiovisual experience during the procedure. The VR headset is a commercially available Meta Quest 3. | Behavioural | Virtual Reality (VR) Audiovisual Distraction |
Primary outcome
Composite Outcome Using Win Ratio Method (Opioid/Sedative Use, Intra-procedural Pain Score, and Intra-procedural Anxiety Score)
Time frame: During the procedure, approximately 30 minutes
The primary outcome is a composite analyzed using the Win Ratio method. Each intervention patient will be compared with each control patient. Pairs are evaluated in priority order: opioid/sedative use, intra-procedural pain score, then intra-procedural anxiety score. A patient who received no opioids/sedatives wins over one who did; if tied, the lower pain score wins; if still tied, the lower anxiety score wins. If all three measures are identical, the pair is a tie. The Win Ratio is calculated as total intervention wins divided by total control wins. A Win Ratio >1 indicates superiority of VR; a 95% confidence interval will be calculated. Pain and anxiety are measured using the Numeric Rating Scale (NRS), from 0 (none) to 10 (worst possible), with higher scores indicating worse outcomes.
8 secondary outcomes
Opioid and Sedative Medication Use
Time frame: During the procedure, approximately 30 minutes
Intra-procedural Pain Score on the Numeric Rating Scale (NRS)
Time frame: During the procedure, approximately 30 minutes
Intra-procedural Anxiety Score on the Numeric Rating Scale (NRS)
Time frame: During the procedure, approximately 30 minutes
Pain Intensity on the Patient-Reported Outcomes Measurement Information System Pain Intensity Short Form-3a (PROMIS Pain Intensity SF-3a)
Time frame: Pre-procedure and post-procedure, approximately 30 minutes
Anxiety on the State-Trait Anxiety Inventory 6-item (STAI-6)
Time frame: Pre-procedure and post-procedure, approximately 30 minutes
Patient Global Impression of Change (PGIC)
Time frame: Post-procedure, approximately 30 minutes
Patient Experience Satisfaction
Time frame: Post-procedure, approximately 30 minutes
Virtual Reality Experience Feedback
Time frame: Post-procedure, approximately 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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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.
Michael J. Jung, MD, MBA 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 (VR) Audiovisual Distraction in people with Procedural Pain and Procedural 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 5 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: opening soon, as of the sponsor's last update on 21 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J. Jung, MD, MBA (916-734-6824, mijjung@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Outcome Using Win Ratio Method (Opioid/Sedative Use, Intra-procedural Pain Score, and Intra-procedural Anxiety Score) (time frame: During the procedure, approximately 30 minutes). 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 21 Aug 2026.