Recruiting

Core Shamanism

Sponsor:

UCLA

Code:

NCT06579261

Conditions

Fibromyalgia

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Core Shamanism

Study Details

Brief 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.

Conditions

Fibromyalgia

Study ID

NCT06579261

Start date

Aug 1, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria for Fibromyalgia participants:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Fibromyalgia participants - Shamanic Intervention

Interventions

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.

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 and Locations

Central contacts

University of California, Irvine Susan Samueli Integrative Health Institute

949-824-7000ssihi@hs.uci.edu

Locations

Susan Samueli Integrative Health Institute

Recruiting

Irvine, California, United States, 92617

Contacts

More Information

Sponsor

University of California, Irvine

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • fibromyalgia chronic pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-06-23.