Music Intervention for Preterm Birth
ConditionPreterm Birth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorColumbia University
About this trial
This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 40 years
Generally healthy pregnant women in the first trimester of pregnancy
Disqualifiers
Non-pregnant women
Women with a chronic medical condition that could impact pregnancy health or duration
Women regularly taking any medications other than prenatal vitamins
Trial design
Design model
Parallel
Treatments tested in this trial
Music Intervention (MI)
BehavioralThe intervention will involve listening, playing and/or singing melodies or songs, that are meaningful to the participant, with interpretation/reflection on their relevance/capacity to alter stress.
Sham Control (SC)
Other interventionThe intervention will be to support a woman to talk about anything she wants that is important to her.
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: Music Intervention (MI) GroupExperimental treatment 1 intervention
Group B: Sham Control (SC) GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Score on the Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a 10-item scale that was developed to measure the degree to which situations in one's life are appraised as stressful. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Scores range from 0 to 40 with higher scores indicating a worse outcome.
Time frame
Week 12
Score on the Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a 10-item scale that was developed to measure the degree to which situations in one's life are appraised as stressful. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Scores range from 0 to 40 with higher scores indicating a worse outcome.
Time frame
Week 53
Score on the Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a 10-item scale that was developed to measure the degree to which situations in one's life are appraised as stressful. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Scores range from 0 to 40 with higher scores indicating a worse outcome.
Time frame
Week 104
Mean Gestational Age
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.
Time frame
Up to 43 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Emory University
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Source ClinicalTrials.gov