The Effects of Core Shamanism in Fibromyalgia
Part of paid clinical trials in Irvine, California.
- Sponsor
- University of California, Irvine
- Study ID
- NCT06579261
- Status
- Recruiting
Conditions
- Fibromyalgia
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Core Shamanism — OTHEREach Shamanic intervention session, led by the shamanic practitioner, will include classical music as a control, followed by repetitive drumming and/or rattling music which the participant and shamanic practitioner will listen to for 15-30 mins. Following listening to drumming, the patient will then talk with the shamanic practitioner to debrief the experience of each session. Participants will also listen to classical music as a control stimulus.
Study Details
This study aims to determine the feasibility of a shamanism intervention for patients with fibromyalgia, acquire efficacy data to determine if Shamanism reduces clinical pain and other common symptoms associated with fibromyalgia, and determine if the Shamanism intervention changes heart rate electrocardiogram (ECG), breathing rate, and brain wave electroencephalogram (EEG) outcomes in fibromyalgia patients and shamanic practitioners. The investigators hypothesize that 80% of individuals will complete at least 80% of study visits, clinical pain severity and/or interference will be significantly reduced following the Shamanic intervention, and lung, heart, and/or brain activity will be altered with the Shamanic intervention and also become more synchronized between Shamanic Practitioners (SPs) and patients during the course of treatment.
Key Dates
- Start date
- Aug 1, 2024
- Status verified
- Oct 2025
- Primary completion
- May 31, 2026
- Completion
- May 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Fibromyalgia participants - Shamanic Intervention
Primary Outcome Measure
Primary Outcomes: Attendance Measurement [ Time Frame: Pre screening (2-4 weeks prior to start of treatment visits), Baseline (Pre treatment visit Day 0), Treatment Visits 1-5 (To be done over 8 week long period), Post Treatment Assessment, 1-, 3-, and 6-month follow ups Post-treatment visit 5 ]
Central Contacts
- University of California, Irvine Susan Samueli Integrative Health Institute949-824-7000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Susan Samueli Integrative Health Institute | Irvine | California | 92617 |
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