A Study Of Virtual Reality Vs Sham VR On Fibromyalgia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Comparative Effects Of Virtual Reality Vs Sham VR On Fibromyalgia Impact: A Randomized Crossover Clinical Trial

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 2, 2025
Registry last updated: Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting