Music Workshops in the EMPOWER Clinic

Trauma Clinical Trial

Official title:

Evaluating the Effect of Music on Emotional Regulation Among Survivors of Sexual Violence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02897505
• Other study ID #: 15-01524
• Status: Withdrawn
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 29, 2018

Study information

• Verified date: April 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women enrolled in the EMPOWER clinic and/or Sanctuary for Families

Exclusion Criteria:

• Unwilling or unable to participate or provide informed consent.

Related Conditions & MeSH terms

• Sex Trafficking
• Sexual Violence
• Trauma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression, Anxiety, and Stress Scale (DASS-21)	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.	Baseline to Three (3) Months
Secondary	Life Events Checklist (LEC-5):	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.	Baseline to Three (3) Months
Secondary	Physiological and Emotion Thermometers Survey	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.	Baseline to Three (3) Months