Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
NCT06579261

The Effects of Core Shamanism in Fibromyalgia

Led by University of California, Irvine · Updated on 2026-01-23

25

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The Effects of Core Shamanism in Fibromyalgia

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Aged over 18 and under 75 years
  • Diagnosed with fibromyalgia meeting the 2016 Fibromyalgia Diagnostic Criteria
  • Average recalled pain over the last 7 days is at least 4 on a 10 cm Visual Analog Scale
  • Willing to avoid starting new medications or treatments for fibromyalgia during the study
  • Able to travel to the study site up to twice weekly for treatment sessions
  • Willing and able to complete all study procedures
  • Capable of providing written informed consent
  • Proficient in speaking, reading, and writing English
Not Eligible

You will not qualify if you...

  • Having an autoimmune or inflammatory disease that causes pain, such as rheumatoid arthritis or lupus
  • History of head injury with significant loss of consciousness
  • Peripheral neuropathy that affects daily activities
  • Routine daily use of opioid analgesics, marijuana, or history of substance abuse
  • Use of stimulant medications for ADD/ADHD or fatigue related to sleep apnea or shift work
  • Participation in other therapeutic trials
  • Use of over-the-counter pain medications on the day of EEG testing
  • Use of opioid pain medications within 48 hours before EEG testing
  • Pregnant or nursing
  • Severe psychiatric illnesses including current schizophrenia or major depression with suicidal thoughts
  • Contraindications to EEG such as surgical clips, staples, metal implants, or certain dental materials
  • Any condition or situation judged by study staff that would prevent completing the study
  • Prior knowledge of Shamanism techniques that could bias outcomes
  • Conditions that make the Shamanism intervention unsafe
  • History of vascular surgery or current vascular problems in lower limbs
  • Uncontrolled cardiovascular disease
  • Current involvement in legal or compensation claims related to fibromyalgia
  • Unable or unwilling to provide written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Susan Samueli Integrative Health Institute

Irvine, California, United States, 92617

Actively Recruiting

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Research Team

U

University of California, Irvine Susan Samueli Integrative Health Institute

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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The Effects of Core Shamanism in Fibromyalgia | DecenTrialz