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Behavioral Intervention
Music Intervention for Premature Birth
N/A
Waitlist Available
Led By Elizabeth J. Corwin, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 43 weeks
Awards & highlights
Study Summary
This trial will test if music can reduce the impact of chronic stress on pregnant Black women, and if it can reduce preterm births and improve baby outcomes.
Who is the study for?
This trial is for healthy pregnant Black women aged 18 to 40 in their first trimester. It's not for those who aren't pregnant, have chronic health issues affecting pregnancy, or take regular medication (other than prenatal vitamins).Check my eligibility
What is being tested?
The study compares a music intervention (MI) with a sham control (SC), which involves only talking. The goal is to see if MI can lessen the stress effects on pregnant women, reduce premature births, and boost infant health.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like music and conversation, side effects are minimal but may include emotional responses or discomfort due to participation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 43 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 43 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Gestational Age
Score on the Perceived Stress Scale (PSS)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Music Intervention (MI) GroupExperimental Treatment1 Intervention
Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states.
Group II: Sham Control (SC) GroupActive Control1 Intervention
Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only).
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,439 Previous Clinical Trials
2,447,593 Total Patients Enrolled
18 Trials studying Premature Birth
8,596 Patients Enrolled for Premature Birth
National Institute on Minority Health and Health Disparities (NIMHD)NIH
393 Previous Clinical Trials
1,220,898 Total Patients Enrolled
2 Trials studying Premature Birth
791 Patients Enrolled for Premature Birth
Emory UniversityOTHER
1,647 Previous Clinical Trials
2,564,499 Total Patients Enrolled
4 Trials studying Premature Birth
6,157 Patients Enrolled for Premature Birth
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant.I have a chronic condition that could affect a pregnancy.I am between 18 and 40 years old.I am a woman taking medication other than prenatal vitamins regularly.I am a healthy pregnant woman in my first trimester.
Research Study Groups:
This trial has the following groups:- Group 1: Music Intervention (MI) Group
- Group 2: Sham Control (SC) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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