A Study Of Virtual Reality Vs Sham VR On Fibromyalgia

Mayo Clinic

Status: Active, not recruiting

Conditions: Fibromyalgia

Treatments: Behavioral: Sham VR; Device: TRIPP VR Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT07202572

25-006773

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Sequence A (TRIPP VR to Sham VR)

Experimental group

Description:

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.

Treatment:

Device: TRIPP VR Meditation

Sequence B (Sham VR to TRIPP VR)

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham VR