A Study Of Virtual Reality Vs Sham VR On Fibromyalgia

NCT07202572 | Active Not Recruiting FDA Device

• 1 other identifier: 25-006773
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 2, and Week 4

Study Arms (2)

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.

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.

Behavioral: Sham VR

Interventions

TRIPP VR Meditation DEVICE

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).

Sequence A (TRIPP VR to Sham VR)

Sham VR BEHAVIORAL

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.

Sequence B (Sham VR to TRIPP VR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Anushka Irani

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the intervention type. They will not be informed whether they are receiving the active intervention (TRIPP VR meditation) or the sham VR. Study staff administering the interventions will not be blinded due to the nature of the VR content and setup requirements.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 2, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)