A Study Of Virtual Reality Vs Sham VR On Fibromyalgia

January 31, 2026 updated by: Anushka Irani, Mayo Clinic

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A (TRIPP VR to Sham VR)
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.
Device: TRIPP VR Meditation
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 Comparator: Sequence B (Sham VR to TRIPP VR)
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.
Behavioral: Sham VR
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 2, and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Anushka Irani, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Actual)

October 2, 2025

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-006773

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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