A Study Of Virtual Reality Vs Sham VR On Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-29

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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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.

Group Type EXPERIMENTAL

TRIPP VR Meditation

Intervention Type 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 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.

Group Type SHAM_COMPARATOR

Sham VR

Intervention Type 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.

Interventions

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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).

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No