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

NCT05893485 · Baylor College of Medicine
In plain English

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Official title
Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus, WOMB (Women on Musical Bedrest)
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: single
Age groups: adult
Timeline
Starts: 2023-05-15
Estimated completion: 2026-03-01
Last updated: 2024-09-19
Interventions
Behavioral: Music Therapy Intervention
Primary outcomes
  • Measure the length of time from when the membranes prematurely rupture to delivery (30 days)
Sponsor
Christina Chianis Reed · other
With: The Methodist Hospital Research Institute
Contacts & investigators
ContactChristina C Reed, NP-BC · contact · Christina.reed@bcm.edu · 2817709027
ContactYamely Mendez Martinez, MD · contact · Yamely.mendezmartinez@bcm.edu · 832-826-7363
InvestigatorChristina Reed, WHNP-BC · principal_investigator, Baylor College of Medicine
All locations (1)
Texas Children's Pavilion for WomenRecruiting
Houston, Texas, United States
Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus · TrialPath