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Core Shamanism for Fibromyalgia Study

This study is exploring if Core Shamanism can help people with fibromyalgia. Researchers want to see if this intervention, which involves listening to classical music followed by drumming or rattling music with a shamanic practitioner, can reduce pain and other common fibromyalgia symptoms. They also want to see if it changes heart rate, breathing, and brain activity. To join, you must be a woman between 18 and 75 years old with fibromyalgia, experiencing pain levels of 4 or higher on a 10-point scale over the last seven days. The study will consider it a success if most participants complete their visits and if pain is significantly reduced after the Core Shamanism sessions.

Study design
This is an interventional study planning to enroll 25 female participants. It involves one-on-one treatment sessions with a shamanic practitioner.
What's involved
You would participate in 5 one-on-one treatment sessions over an 8-week period. These sessions include listening to music and having your heart rate, breathing, and brain activity measured.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up assessments at 1, 3, and 6 months after your last treatment session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06579261

The Effects of Core Shamanism in Fibromyalgia

Recruiting
NAAges 18–75Interventional
University of California, Irvine
~25 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Core Shamanism

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcomes: Attendance Measurement
Measured over 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

Conditions

Fibromyalgia

Explore related trials

Fibromyalgia

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Richard E Richard, PhD · PRINCIPAL_INVESTIGATOR · UCI SSIHI

Who to contact

University of California, Irvine Susan Samueli Integrative Health Institute
[email protected]
949-824-7000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Female
Over 18 and under 75 years of age.
Fibromyalgia patients and satisfies the 2016 Fibromyalgia Diagnostic Criteria for the classification of FM.
Mean recalled pain over the last seven days (7-day recall) greater than or equal to 4 on a 10 cm Visual Analog Scale (VAS) for pain; 7-day recall.
Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.
Able to travel to the study site to receive shamanic treatments up to twice weekly.
Understanding and willing to complete all study procedures.
Capable of giving written informed consent.
Proficient ability to speak, read, and write in english.

Exclusion

Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain.
History of head injury with substantial loss of consciousness
Peripheral neuropathy of known cause that interferes with activities of daily living.
Routine daily use of opioid analgesics, marijuana, or history of substance abuse.
Stimulant medications, such as those used to treat Attention Deficit Disorder (ADD)/Attention-deficit/hyperactivity disorder (ADHD). (e.g., amphetamine/ dextroamphetamine \[Adderall®\], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
Concurrent participation in other therapeutic trials.
Use of as needed (PRN) over the counter (OTC) pain medications (Nonsteroidal anti-inflammatory drugs (NSAIDs), etc.) on day of electroencephalogram (EEG) testing.
Use of PRN opioid analgesics 48 hours prior to electroencephalogram (EEG) testing.
Pregnant or nursing. A pregnancy test will be given prior to electroencephalogram (EEG) sessions.
Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
Contraindications to EEG methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material.
Any impairment, activity or situation that is in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.
Sufficient knowledge of Shamanism techniques that may bias participant outcomes.
Presence of factors that may preclude the safe use of the Shamanism intervention.
History vascular surgery in lower limbs or current lower limb vascular dysfunction.
Presence of uncontrolled cardiovascular disease.
Subjects with Worker's Compensation, Workman's Compensation, civil litigation or disability claims pertinent to the subject's fibromyalgia; current involvement in out-of-court settlements for claims pertinent to the subject's fibromyalgia; or currently receiving monetary compensation as a result of any of the above.
Inability or unwillingness of an individual to give written informed consent.

What this trial measures

  • Primary Outcomes: Attendance MeasurementPre 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

    To investigate the primary outcome of feasibility, the investigators will record attendance and assess how many Fibromyalgia (FM) patients complete 80% of treatment visits (4 out of 5 sessions). Participants who complete at least 80% of visits will be marked as a completer and those who attend less than 80% of treatment visits will be marked as a "non-completer". The investigators will perform a completer versus non-completer analysis on all participants enrolled.