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

Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus, WOMB (Women on Musical Bedrest)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05893485
Acronym
WOMB
Enrollment
60
Registered
2023-06-08
Start date
2023-05-15
Completion date
2026-03-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Music Therapy, Preterm Premature Rupture of Membrane (PPROM)

Keywords

Music therapy, Antepartum, Preterm Premature Rupture of Membranes (PPROM), Fetus, Woman, Post Traumatic Stress Disorder, Postpartum Depression, Anxiety, Stress

Brief summary

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

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.

Interventions

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

Sponsors

The Methodist Hospital Research Institute
CollaboratorOTHER
Christina Chianis Reed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Measure the length of time from when the membranes prematurely rupture to delivery30 daysTime will be measured in hours from when the membranes prematurely rupture between 24 and 34 weeks of gestational age. The time will be compared to those who do not receive music therapy. The shorter the time interval means worse outcomes.

Secondary

MeasureTime frameDescription
Music therapy in relation to maternal tachycardia due to stress30 daysDetermine if music therapy sessions change heart rate on tachycardic women with reported stress.
Edinburgh Postnatal Depression Scale score before and after music therapy30 daysEvaluate the Edinburgh Postnatal Depression Scale scores before and after music therapy. The minimum score is 0 and the maximum score is 30. Possible depression is 10 or greater. Greater the score the worse the outcome. Always look at question number 10 regarding suicidal thoughts.
Visual analogue scale for anxiety before and after music therapy30 daysCorrelate the Visual Analogue Scale measuring the state anxiety (VAS-A) scores both antepartum and postpartum in patients who receive music therapy. The Visual Analogue Scale for Anxiety is a 10 centimeter line with the minimum score of not at all anxious to the left and the maximum score of very anxious to the right. The more anxious a person is they put a mark on closer to very anxious which is the worse outcome.
Change in anxiety levels in relation to the length of hospital stay30 daysDetermine if there is a relationship between anxiety levels and hospital length of stay. The hospital length of stay is measured by hours spent in-patient at the hospital. Anxiety levels will be assessed using the Visual Analogue Scale for Anxiety. The Visual Analogue Scale for Anxiety is a 10 centimeter line with the minimum score of not at all anxious to the left and the maximum score of very anxious to the right. The more anxious a person is they put a mark on closer to very anxious which is the worse outcome.
Change in the time interval between delivery and newborn receiving their mother's breastmilk30 daysChange in the time interval between delivery and newborn receiving their mother's breastmilk normalized to gestational age at delivery.
Change in blood pressure before and after music therapy30 daysMeasure blood pressure at pre-determined times before and after music therapy. Higher blood pressure is a worse outcome.
Music therapy in relation to infant bonding30 daysParticipants express increased connection/bonding with their infant through a questionnaire given to them at their 6 week postpartum visit. The question has yes or no answers. The participant will choose yes if they feel an increased connection/bonding with their infant and participants will choose no if they do not feel an increased connection/bonding with their infant. The answer choice no is the worse outcome.

Countries

United States

Contacts

Primary ContactChristina C Reed, NP-BC
Christina.reed@bcm.edu2817709027
Backup ContactYamely Mendez Martinez, MD
Yamely.mendezmartinez@bcm.edu832-826-7363

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026