RECRUITING

The Effects of Core Shamanism in Fibromyalgia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Core Shamanism in Fibromyalgia

Quick Facts

Study Start:2024-08-01

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06579261

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Study Contact

University of California, Irvine Susan Samueli Integrative Health Institute

CONTACT

949-824-7000

ssihi@hs.uci.edu

Principal Investigator

Richard E Richard, PhD

PRINCIPAL_INVESTIGATOR

UCI SSIHI

Study Locations (Sites)

Susan Samueli Integrative Health Institute

Irvine, California, 92617

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Richard E Richard, PhD, PRINCIPAL_INVESTIGATOR, UCI SSIHI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01

Study Completion Date2025-04

Study Record Updates

Study Start Date2024-08-01

Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

fibromyalgia chronic pain

Additional Relevant MeSH Terms

Fibromyalgia