- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01873482
Traditional African Healing Ceremony in a U.S. Population
October 31, 2014 updated by: Duke University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
-
-
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.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Movement with rhythm
Subjects will move for 1 hour in time to the Congolese rhythm called Zebola.
|
Movement to rhythm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Report from each participant as to whether they found the experience positive, neutral or negative.
Time Frame: During the first hour after the intervention
|
During the first hour after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
written narrative of experience
Time Frame: During the first hour after the intervention
|
During the first hour after the intervention
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Encounter group discussion
Time Frame: During the first hour after the intervention
|
During the first hour after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth Wilson, MD, Duke University
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 Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
June 5, 2013
First Submitted That Met QC Criteria
June 6, 2013
First Posted (Estimate)
June 10, 2013
Study Record Updates
Last Update Posted (Estimate)
November 2, 2014
Last Update Submitted That Met QC Criteria
October 31, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00042492
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.