Music Workshops in the EMPOWER Clinic

Sponsor
NYU Langone Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02897505
Collaborator
(none)
0
1
19.9

Study Details

Study Description

Brief Summary

Women will be recruited from the EMPOWER clinic when they present for care; they may be given a flyer as part of their clinic entry paperwork, or approached by a study staff member in the waiting area of the clinic. Women who are clients of Sanctuary for Families may find out about the music workshops and the study through Sanctuary for Families staff, who will post flyers in their noticeboards or offices.

This study will use a repeated measures survey design to evaluate the effect of a musical workshop intervention to aid in the management of mood, anxiety, and stress among women enrolled in the EMPOWER clinic for survivors of sex trafficking and sexual violence. Assessment of the feasibility and acceptability of this music intervention will be carried out on participants as they are taught to manage stress and emotions.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music Workshop
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating the Effect of Music on Emotional Regulation Among Survivors of Sexual Violence
Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
May 29, 2018
Actual Study Completion Date :
May 29, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Women enrolled in Empower Clinic

Women who are enrolled in the Empower Sanctuary will be asked to participate in a Music Workshop

Behavioral: Music Workshop
At each music workshop, the study staff will collect participants' pre- and post-session Physiological and Emotional Thermometer Surveys. The pre-session survey will be conducted prior to the start of the music workshop, and the post-session survey will be conducted within 15 minutes after the conclusion of the workshop.

Outcome Measures

Primary Outcome Measures

  1. Depression, Anxiety, and Stress Scale (DASS-21) [Baseline to Three (3) Months]

    The DASS-21 is a 21-item self-report questionnaire that measures the severity of a range of core depression, anxiety, and stress symptoms. [6] The DASS-21 has been translated and validated in many languages, including Spanish, French and Chinese. In this study, the DASS-21 is conducted three times: at the beginning of the study (pre-intervention), at the end of the study (post-intervention), and at 3 months after the study (3-month follow-up). The DASS-21 can be completed in 5-7 minutes.

Secondary Outcome Measures

  1. Life Events Checklist (LEC-5): [Baseline to Three (3) Months]

    The LEC is a widely used self-report questionnaire that assesses participants' exposure to 16 potentially traumatic events and one additional stressful event not captured in the other 16 items. The LEC has been translated and validated in many languages, and can be completed in 5-7 minutes.

  2. Physiological and Emotion Thermometers Survey [Baseline to Three (3) Months]

    The Physiological and Emotion Thermometers Survey records information on participants' physiological indicators (heart rate and blood pressure) and self-reported answers on the Emotion Thermometers, which is a simple visual-analogue tool used to detect and monitor emotional disorders and has been translated in many languages including Spanish, French and Chinese. The survey is conducted at the beginning and at the end of each music workshop (pre- and post-session, respectively) that the participant attends, and can be completed in 2-5 minutes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Women enrolled in the EMPOWER clinic and/or Sanctuary for Families
Exclusion Criteria:
  • Unwilling or unable to participate or provide informed consent.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Veronica Ades, MD, New York University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT02897505
Other Study ID Numbers:
  • 15-01524
First Posted:
Sep 13, 2016
Last Update Posted:
Apr 5, 2019
Last Verified:
Apr 1, 2019
Keywords provided by NYU Langone Health

Study Results

No Results Posted as of Apr 5, 2019