Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579261
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
The Effects of Core Shamanism in Fibromyalgia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Core Shamanism in Fibromyalgia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor interference will be significantly reduced following the Shamanic intervention and lung heart andor 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
The investigators hypothesize that 80 of individuals will complete at least 80 of study visits clinical pain severity andor interference will be significantly reduced following the Shamanic intervention and lung heart andor 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 beatssec 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None