CClinicalTrials.gg
WithdrawnNCT02897505Updated Apr 5, 2019

Music Workshops in the EMPOWER Clinic

An interventional study of Music Workshop in Sex Trafficking, Sexual Violence and Trauma, sponsored by NYU Langone Health. Withdrawn. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-05.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Difficulty enrolling subjects
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Sex Trafficking
  • Sexual Violence
  • Trauma

Keywords

  • post traumatic stress disorder (PTSD)
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unwilling or unable to participate or provide informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralMusic 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to Three (3) Months

Secondary outcomes

  1. 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.

    Time frame: Baseline to Three (3) Months

  2. 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.

    Time frame: Baseline to Three (3) Months

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02897505
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Sep 13, 2016
Start date
Oct 2016
Primary completion
May 29, 2018
Completion
May 29, 2018
Last update
Apr 5, 2019

Study contacts

Veronica Ades, MD
principal investigator · New York University Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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