Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus

NCT ID: NCT05893485

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2026-03-01

Brief Summary

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To evaluate the effects of music therapy in the care of antepartum mothers admitted for long-term hospitalization due to the high-risk status of their pregnancy. The investigators speculate that mothers who receive music therapy will be more successful in forming positive coping habits, bonding with their infant, and increasing the length of incubation during their pregnancy.

Furthermore, there is no research that correlates music therapy applied to stress reduction, increased coping, and increased caregiver-infant bonding prior to birth within one protocol. However, there is a significant amount of research supporting music therapy efficacy with neonatal intensive care unit infants and caregiver bonding post-partum as well as improved physiological signs of stress in infants in the post-partum period.

Detailed Description

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The investigators will identify and screen patients who are admitted to the Texas Children's Pavilion for Women and Houston Methodist Willowbrook with a clinical diagnosis of threatened preterm birth caused by preterm premature rupture of membranes (PPROM), between a gestational age of 24 and 36 weeks. The investigators will approach the patients to discuss this study and if they are interested in participating, the investigators will provide the informed consent form for their signature. After that, the investigators will start collecting data, such as basic demographic information and the Edinburgh Postnatal Depression Scoring scale (EDPS) scores that are clinically taken before and after the PPROM diagnosis.

Inclusion Criteria:

1. Pregnant women between 18 and 64 years of age.
2. Singleton pregnancy.
3. Hospital admission due to a high risk of premature delivery.
4. Confirmed diagnosis of preterm premature rupture of membranes.
5. Length of stay in the hospital for 48 hours or more and stable for 48 hours or more.
6. Patients willing to listen to music.
7. Patients willing to participate throughout all the music therapy sessions and the postpartum follow-up visit.

Exclusion Criteria:

1. Hospital length of stay of less than 48 hours.
2. Non-singleton pregnancy.
3. Gravidae with severe medical and or surgical complications during their hospital admission that prevents them from participating in Music Therapy sessions.

Conditions

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Music Therapy Preterm Premature Rupture of Membrane (PPROM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

No Music Therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Music Therapy Intervention

Four music therapy sessions provided prior to delivery.

Group Type ACTIVE_COMPARATOR

Music Therapy Intervention

Intervention Type BEHAVIORAL

Music Therapy Sessions. There will be 4 scheduled music therapy sessions, and a postpartum follow up.

Interventions

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Music Therapy Intervention

Music Therapy Sessions. There will be 4 scheduled music therapy sessions, and a postpartum follow up.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Pregnant women between 18 and 64 years of age.
2. Singleton pregnancy.
3. Hospital admission due to a high risk of premature delivery.
4. Confirmed diagnosis of preterm premature rupture of membranes.
5. Length of stay in the hospital for 48 hours or more and stable for 48 hours or more.
6. Patients willing to listen to music.
7. Patients willing to participate throughout all the music therapy sessions and the postpartum follow-up visit.

Exclusion Criteria

1. Hospital length of stay of less than 48 hours.
2. Non-singleton pregnancy Gravidae with severe medical and or surgical complications during their hospital admission that prevents them from participating in Music Therapy sessions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Methodist Hospital Research Institute

OTHER

Sponsor Role collaborator

Christina Chianis Reed

OTHER

Sponsor Role lead

Responsible Party

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Christina Chianis Reed

Assistant Professor of OB/GYN, Dir of Ops Placenta Accreta Care Team, and Dir of Clinical Research

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christina Reed, WHNP-BC

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Texas Children's Pavilion for Women

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christina C Reed, NP-BC

Role: CONTACT

2817709027

Yamely Mendez Martinez, MD

Role: CONTACT

832-826-7363

Facility Contacts

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Christina C Reed, WHNP-BC

Role: primary

281-770-9027

Yamely Mendez Martinez, MD

Role: backup

832 8267363

References

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Corey K, Fallek R, Benattar M. Bedside Music Therapy for Women during Antepartum and Postpartum Hospitalization. MCN Am J Matern Child Nurs. 2019 Sep/Oct;44(5):277-283. doi: 10.1097/NMC.0000000000000557.

Reference Type BACKGROUND
PMID: 31274510 (View on PubMed)

Teckenberg-Jansson P, Turunen S, Pölkki T, et al. Effects of live music therapy on heart rate variability and self-reported stress and anxiety among hospitalized pregnant women: A randomized controlled trial. Nordic Journal of Music Therapy. 2019; 28(1): 7-26.

Reference Type BACKGROUND

Yang M, Li L, Zhu H, Alexander IM, Liu S, Zhou W, Ren X. Music therapy to relieve anxiety in pregnant women on bedrest: a randomized, controlled trial. MCN Am J Matern Child Nurs. 2009 Sep-Oct;34(5):316-23. doi: 10.1097/01.NMC.0000360425.52228.95.

Reference Type BACKGROUND
PMID: 19713801 (View on PubMed)

Other Identifiers

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H-52059

Identifier Type: -

Identifier Source: org_study_id

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