- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06513845
Drum Circle Synchrony Study 2c.a.
Evaluating the Impact of Community-Based Mindfulness and Musical Programs on Psychiatric Measures, Drum Circle Synchrony Study 2c.a.
Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.
2c.a. Drum Circle Synchrony Study: This study will investigate the role that synchrony plays in subjective feelings of connection.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators also propose a study to investigate the effects of communal drumming in reducing anxiety and increasing connectedness within drum circle community. Investigators hypothesize that these intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care.
Musicians and non-musicians will listen to segments (~30 sec duration) of recordings taken from the music made during a previous arm of drum circle and answer a survey. Segments will be categorized as highly synchronized or not synchronized.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06515
- BLOOM
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New Haven, Connecticut, United States, 06520
- Musical Intervention Studios
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ages 18 and older
Exclusion Criteria:
- ages 17 and younger
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Musicians group
Musicians will listen to segments (~30 sec duration) of recordings taken from the music made during the previous drum circle and answer a survey asking how connected they felt while listening.Segments will be categorized as highly synchronized or not synchronized.
|
Segments (~30 sec duration) of recordings taken from the music made during the previous drum circle.
Segments will be categorized as highly synchronized
|
|
Experimental: Non-musicians group
Non-musicians will listen to segments (~30 sec duration) of recordings taken from the music made during the previous drum circle and answer a survey asking how connected they felt while listening.Segments will be categorized as highly synchronized or not synchronized..
|
Segments (~30 sec duration) of recordings taken from the music made during the previous drum circle.
Segments will be categorized as highly synchronized
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean score connectedness rating
Time Frame: measured during listening session (30minutes)
|
Mean connectedness rating survey assessed using a Likert scale total range of 1 (no connection) to 7 (maximum connection) for synchronous and asynchronous audio samples
|
measured during listening session (30minutes)
|
|
Mean score subjective rating of synchrony
Time Frame: measured during listening session (30minutes)
|
Subjective ratings of synchrony will be assessed using a Likert scale with total score range from 1-5, with higher scores indicating more synchrony, for synchronous and asynchronous audio samples.
|
measured during listening session (30minutes)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: AZA Allsop, MD, PhD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000028866_e
- 2R25MH071584-11 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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