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

Christina Chianis Reed

Status: Enrolling

Conditions: Preterm Premature Rupture of Membrane (PPROM); Music Therapy

Treatments: Behavioral: Music Therapy Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05893485

H-52059

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control

No Intervention group

Description:

No Music Therapy

Music Therapy Intervention

Active Comparator group

Description:

Four music therapy sessions provided prior to delivery.

Treatment:

Behavioral: Music Therapy Intervention