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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anushka Irani | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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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.
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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.
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| 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. |
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| D009422 |
| Nervous System Diseases |