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Traditional African Healing Ceremony in a U.S. Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01873482
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE June 5, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date November 3, 2014
Study Start Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
Report from each participant as to whether they found the experience positive, neutral or negative. [ Time Frame: During the first hour after the intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01873482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
written narrative of experience [ Time Frame: During the first hour after the intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 6, 2013)
Encounter group discussion [ Time Frame: During the first hour after the intervention ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Traditional African Healing Ceremony in a U.S. Population
Official Title  ICMJE Traditional African Healing Ceremony in a U.S. Population
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chronic Fatigue Syndrome
  • Anxiety
  • Depression
  • Cancer
Intervention  ICMJE Behavioral: Movement to rhythm
Movement to rhythm
Study Arms  ICMJE Experimental: Movement with rhythm
Subjects will move for 1 hour in time to the Congolese rhythm called Zebola.
Intervention: Behavioral: Movement to rhythm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2014)
17
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2013)
25
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873482
Other Study ID Numbers  ICMJE Pro00042492
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Wilson, MD Duke University
PRS Account Duke University
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP