NCT01873482

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

Same day

First QC Date

June 5, 2013

Last Update Submit

October 31, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Report from each participant as to whether they found the experience positive, neutral or negative.

    During the first hour after the intervention

Secondary Outcomes (1)

  • written narrative of experience

    During the first hour after the intervention

Other Outcomes (1)

  • Encounter group discussion

    During the first hour after the intervention

Study Arms (1)

Movement with rhythm

EXPERIMENTAL

Subjects will move for 1 hour in time to the Congolese rhythm called Zebola.

Behavioral: Movement to rhythm

Interventions

Movement to rhythm

Movement with rhythm

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • physical disability making participation difficult and previous experience with a similar ceremony, for instance while growing up in Africa.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, ChronicAnxiety DisordersDepressionNeoplasms

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Kenneth Wilson, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2013

First Posted

June 10, 2013

Study Start

May 1, 2014

Primary Completion

May 1, 2014

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations