FibromyalgiaNCT07202572
A Study Of Virtual Reality Vs Sham VR On Fibromyalgia
A study testing TRIPP VR Meditation in people with Fibromyalgia, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to understand the therapeutic impact of VR on Fibromyalgia symptoms and potentially increase the scope of treatment options for patients suffering from Fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- TRIPP VR Meditation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 31 Dec 2026
- 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
- Adults aged >18 years old
- Diagnosis of fibromyalgia based on ACR 2016 criteria
- Stable on current medications and non-pharmacologic treatments for 4 weeks
- Ability and willingness to use a Meta Quest 3 VR headset Fluent in English
- Provide informed consent
Who cannot join
- History of seizures or conditions contraindicating VR use
- Severe psychiatric illness (e.g., psychosis)
- Cognitive impairment interfering with study participation
- Participation in other interventional trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects Of Virtual Reality Vs Sham VR On Fibromyalgia Impact: A Randomized Crossover Clinical Trial
The purpose of this study is to understand the therapeutic impact of VR on Fibromyalgia symptoms and potentially increase the scope of treatment options for patients suffering from Fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- TRIPP VR Meditation, Sham VR
- Keywords
- Virtual Reality
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIPP VR MeditationDevice
Participants engage with the TRIPP virtual reality meditation program for 2 weeks. The TRIPP platform delivers guided mindfulness and breathing exercises through an immersive VR environment designed to promote relaxation and emotional regulation. Sessions are delivered via VR headset and used on a regular schedule (e.g., daily or as prescribed).
Sham VRBehavioural
Participants engage with a sham virtual reality experience for 2 weeks. The sham VR consists of non-therapeutic, visually engaging content without meditative, guided mindfulness, or relaxation components. It is designed to mimic the immersive nature of the TRIPP VR platform without delivering active therapeutic content.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (TRIPP VR to Sham VR) | Experimental | Participants in this arm will receive 2 weeks of TRIPP VR meditation followed by a 2-week washout period, then 2 weeks of sham VR. Receives: Device: TRIPP VR Meditation |
| Sequence B (Sham VR to TRIPP VR) | Sham comparator | Participants in this arm will receive 2 weeks of sham VR followed by a 2-week washout period, then 2 weeks of TRIPP VR meditation. Receives: Behavioral: Sham VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Score After Sham vs. Active VR
The primary outcome is the change in Fibromyalgia Impact Questionnaire Revised (FIQR) score from baseline to post-intervention, comparing scores after sham VR and after active TRIPP VR meditation. FIQR ranges from 0-100 and higher scores indicate higher impact of the condition, ie are worse. FIQR will be measured at baseline, week 2, and week 4. For Sequence A, the sham VR score is taken at week 4; for Sequence B, at week 2. For Sequence A, the active VR score is at week 2; for Sequence B, at week 4. The primary comparison will be the within-subject difference in FIQR change from baseline between sham and active VR periods.
Measured: Baseline, Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start29 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- This study is a randomized, controlled, two-period crossover clinical trial designed to evaluate the effects of TRIPP VR meditation in individuals with fibromyalgia. Twenty participants will be randomly assigned in a 1:1 ratio to one of two intervention sequences: Sequence A will receive TRIPP VR meditation for 2 weeks, followed by a 2-week washout period, then 2 weeks of sham VR; Sequence B will receive sham VR for 2 weeks, followed by a 2-week washout period, then 2 weeks of TRIPP VR meditation. The crossover design allows each participant to serve as their own control, and the washout period is intended to minimize potential carryover effects between intervention phases.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anushka Irani, Mayo Clinic
- Investigators
- Anushka Irani, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202572
- Sponsor's protocol ID
- 25-006773
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Virtual Reality Vs Sham VR On Fibromyalgia Impact: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07202572
- Acronym / sponsor ID
- 25-006773
- Conditions
- Fibromyalgia
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Oct 2025 (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 understand the therapeutic impact of VR on Fibromyalgia symptoms and potentially increase the scope of treatment options for patients suffering from Fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a randomized, controlled, two-period crossover clinical trial designed to evaluate the effects of TRIPP VR meditation in individuals with fibromyalgia. Twenty participants will be randomly assigned in a 1:1 ratio to one of two intervention sequences: Sequence A will receive TRIPP VR meditation for 2 weeks, followed by a 2-week washout period, then 2 weeks of sham VR; Sequence B will receive sham VR for 2 weeks, followed by a 2-week washout period, then 2 weeks of TRIPP VR meditation. The crossover design allows each participant to serve as their own control, and the washout period is intended to minimize potential carryover effects between intervention phases.
| Arm | Type | Receives |
|---|---|---|
| Sequence A (TRIPP VR to Sham VR) | Experimental | Device: TRIPP VR MeditationParticipants in this arm will receive 2 weeks of TRIPP VR meditation followed by a 2-week washout period, then 2 weeks of sham VR. |
| Sequence B (Sham VR to TRIPP VR) | Sham comparator | Behavioral: Sham VRParticipants in this arm will receive 2 weeks of sham VR followed by a 2-week washout period, then 2 weeks of TRIPP VR meditation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged >18 years old
- Diagnosis of fibromyalgia based on ACR 2016 criteria
- Stable on current medications and non-pharmacologic treatments for 4 weeks
- Ability and willingness to use a Meta Quest 3 VR headset Fluent in English
- Provide informed consent
Key exclusion criteria (4 listed)
- History of seizures or conditions contraindicating VR use
- Severe psychiatric illness (e.g., psychosis)
- Cognitive impairment interfering with study participation
- Participation in other interventional trials
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 |
|---|---|---|
| TRIPP VR MeditationParticipants engage with the TRIPP virtual reality meditation program for 2 weeks. The TRIPP platform delivers guided mindfulness and breathing exercises through an immersive VR environment designed to promote relaxation and emotional regulation. Sessions are delivered via VR headset and used on a regular schedule (e.g., daily or as prescribed). | Device | Sequence A (TRIPP VR to Sham VR) |
| Sham VRParticipants engage with a sham virtual reality experience for 2 weeks. The sham VR consists of non-therapeutic, visually engaging content without meditative, guided mindfulness, or relaxation components. It is designed to mimic the immersive nature of the TRIPP VR platform without delivering active therapeutic content. | Behavioural | Sequence B (Sham VR to TRIPP VR) |
Primary outcome
Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Score After Sham vs. Active VR
Time frame: Baseline, Week 2, and Week 4
The primary outcome is the change in Fibromyalgia Impact Questionnaire Revised (FIQR) score from baseline to post-intervention, comparing scores after sham VR and after active TRIPP VR meditation. FIQR ranges from 0-100 and higher scores indicate higher impact of the condition, ie are worse. FIQR will be measured at baseline, week 2, and week 4. For Sequence A, the sham VR score is taken at week 4; for Sequence B, at week 2. For Sequence A, the active VR score is at week 2; for Sequence B, at week 4. The primary comparison will be the within-subject difference in FIQR change from baseline between sham and active VR periods.
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 3 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Anushka Irani principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRIPP VR Meditation in people with Fibromyalgia, run by Mayo Clinic 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 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. Some participants in this study may receive a placebo. 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?
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?
Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Score After Sham vs. Active VR (time frame: Baseline, Week 2, and Week 4). 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 Feb 2026.