Preterm BirthNCT05945264
Music Intervention for Preterm Birth
A study testing Music Intervention (MI) in people with Preterm Birth, run by Columbia University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Music Intervention (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Sep 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 40 years
- Generally healthy pregnant women in the first trimester of pregnancy
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
New York, New York, 10003
- Recruiting
Columbia University Irving Medical Center/NewYork Presbyterian
New York, New York, 10032
Jacquelyn Taylor, PhD, 347-978-2871, jyt2116@cumc.columbia.edu
Jacquelyn Taylor, PhD
About this study
Official title: The Impact of a Culturally-based Live Music Intervention on the Metabolites and Metabolic Pathways Associated With Chronic Stress and the Risk of Pre-term Birth in Black Women
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.
Read the detailed description
Preterm birth occurs at unacceptably high rates in the United States, with Black women disproportionately affected. A long-recognized risk factor for preterm birth in this population is the relentless exposure to intersectional stress related to racial and sexual discrimination, poverty, and neighborhood disadvantage that Black women often experience from an early age. In this interdisciplinary study, the investigators bring together experts in preterm birth, music therapy, and metabolomics to address this health disparity by testing the efficacy of a live, culturally based music intervention to reduce the production of metabolites and metabolic pathways associated with chronic stress and thereby improve birth outcomes.
- Conditions
- Preterm Birth
- Being tested
- Music Intervention (MI), Sham Control (SC)
- Keywords
- Chronic stress, Preterm birth, Black women stress, Metabolomics of chronic stress, Music and medicine, Music intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Intervention (MI)Behavioural
The 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
Also called Verbal intervention
The intervention will be to support a woman to talk about anything she wants that is important to her.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention (MI) Group | Experimental | Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states. Receives: Behavioral: Music Intervention (MI) |
| Sham Control (SC) Group | Active comparator | Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only). Receives: Other: Sham Control (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 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.
Measured: Week 5
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.
Measured: Week 10
Mean Gestational Age
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.
Measured: Up to 43 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start29 Sep 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Emory University, Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Jacquelyn Taylor, Columbia University
- Investigators
- Jacquelyn Taylor, PhD, Principal investigator, Columbia UniversityJoanne V. Loewy, DA, LCAT, MT-BC, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945264
- Sponsor's protocol ID
- ACYY0271
- Other IDs
- R01MD016899, AAAU6262
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared, but de-identified composite data with be shared with authorized recipients at the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Culturally-based Live Music Intervention on the Metabolites and Metabolic Pathways Associated With Chronic Stress and the Risk of Pre-term Birth in Black Women
- ClinicalTrials.gov ID
- NCT05945264
- Acronym / sponsor ID
- ACYY0271
- Conditions
- Preterm Birth
- Keywords
- Chronic stress, Preterm birth, Black women stress, Metabolomics of chronic stress, Music and medicine, Music intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Emory University, Icahn School of Medicine at Mount Sinai
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preterm birth occurs at unacceptably high rates in the United States, with Black women disproportionately affected. A long-recognized risk factor for preterm birth in this population is the relentless exposure to intersectional stress related to racial and sexual discrimination, poverty, and neighborhood disadvantage that Black women often experience from an early age. In this interdisciplinary study, the investigators bring together experts in preterm birth, music therapy, and metabolomics to address this health disparity by testing the efficacy of a live, culturally based music intervention to reduce the production of metabolites and metabolic pathways associated with chronic stress and thereby improve birth outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Intervention (MI) Group | Experimental | Behavioral: Music Intervention (MI)Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states. |
| Sham Control (SC) Group | Active comparator | Other: Sham Control (SC)Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18 to 40 years
- Generally healthy pregnant women in the first trimester of pregnancy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Intervention (MI)The 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. | Behavioural | Music Intervention (MI) Group |
| Sham Control (SC)Also: Verbal interventionThe intervention will be to support a woman to talk about anything she wants that is important to her. | Other | Sham Control (SC) Group |
Primary outcome
Score on the Perceived Stress Scale (PSS)
Time frame: Week 1
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.
Score on the Perceived Stress Scale (PSS)
Time frame: Week 5
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.
Score on the Perceived Stress Scale (PSS)
Time frame: Week 10
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.
Mean Gestational Age
Time frame: Up to 43 weeks
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared, but de-identified composite data with be shared with authorized recipients at the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacquelyn Taylor, PhD principal investigator
Columbia University
Joanne V. Loewy, DA, LCAT, MT-BC principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Intervention (MI) in people with Preterm Birth, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacquelyn Taylor, PhD (347-978-2871, jyt2116@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Perceived Stress Scale (PSS) (time frame: Week 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.