NCT06579261

The Effects of Core Shamanism in Fibromyalgia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study includes an 8-week long intervention, with 5 one-on-one treatment sessions with Fibromyalgia (FM) participants and shamanic practitioners (SPs). During each treatment session the FM participant will listen to classical music first as a control, followed by drumming music (4-7 beats/sec) for 15-30 minutes with the SP and a debrief session. The SP will employ the structure and principles of "Core Shamanism" as developed by Michael Harner. The first and last treatment sessions will include EEG measurements of both the patient and practitioner, while all sessions will have ECG and breathing rate for both patient and practitioner. Pre screening questionnaires will be administered prior to shamanic treatments to ensure patients and SPs meet study inclusion criteria and give consent to the intervention. Following consent, pre and post treatment questionnaires will be administered to patient and SP participants to capture symptoms of fibromyalgia and treatment related experiences. 1-, 3-, and 6-month followup visits will involve the same questionnaires being administered and recorded to assess durability of treatment response.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
OTHER	Core Shamanism	Each 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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-08-30
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States