Traditional African Healing Ceremony in a U.S. Population

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01873482
First received: June 5, 2013
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

Pre-agricultural societies almost universally used healing ceremonies that involved reverence, rhythm and dance in the presence of a healer. It is believed that we are "wired" for such experiences and they foster an integrative mode of consciousness similar to that of mindfulness based stress reduction, which has been shown to have therapeutic effects in a variety of conditions. Collaborator Ava Lavonne Vinesett of the Duke Dance Program has developed a healing ceremony based in sub-Saharan African traditions. The investigators plan is to have 25 subjects with a variety of clinical conditions participate in this ceremony. Subjects will then be asked to write a commentary about their experience and to participate in a focus group discussion. It is anticipated that the study will give us some idea of how promising this approach would be and what kinds of patients might benefit. Safety issues are minimal and include the possibility of injury (though the dancing is not strenuous) and psychological distress.


Condition Intervention
Chronic Fatigue Syndrome
Anxiety
Depression
Cancer
Behavioral: Movement to rhythm

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Traditional African Healing Ceremony in a U.S. Population

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Report from each participant as to whether they found the experience positive, neutral or negative. [ Time Frame: During the first hour after the intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • written narrative of experience [ Time Frame: During the first hour after the intervention ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Encounter group discussion [ Time Frame: During the first hour after the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: February 2014
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Movement with rhythm
Subjects will move for 1 hour in time to the Congolese rhythm called Zebola.
Behavioral: Movement to rhythm
Movement to rhythm

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 25 to 65 with one of the diagnoses listed above or with 8 visits to their provider in the last year and with no diagnosis of chronic illness.

Exclusion Criteria:

  • physical disability making participation difficult and previous experience with a similar ceremony, for instance while growing up in Africa.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873482

Contacts
Contact: Kenneth Wilson, MD 919-684-5878 wilso003@mc.duke.edu

Locations
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Kenneth Wilson, MD    919-684-5878    wilso003@mc.duke.edu   
Principal Investigator: Kenneth Wilson, MD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Kenneth Wilson, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01873482     History of Changes
Other Study ID Numbers: Pro00042492
Study First Received: June 5, 2013
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Anxiety Disorders
Depression
Depressive Disorder
Fatigue
Mental Disorders
Behavioral Symptoms
Mood Disorders
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 28, 2014