A Study Of Virtual Reality Vs Sham VR On Fibromyalgia

Not Applicable

Active, not recruiting

• Conditions: Virtual Reality; Sham VR; Fibromyalgia

• Registration Number: NCT07202572
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-29
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Score After Sham vs. Active VR	Baseline, Week 2, and Week 4	The primary outcome is the change in FIQR score from baseline to post-intervention, comparing scores after sham VR and after active TRIPP VR meditation. 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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States