Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Music Therapy Intervention.
- Who it may be relevant to
- Registry conditions: Music Therapy, Preterm Premature Rupture of Membrane (PPROM). Basic parameters: 18 years — 64 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus, WOMB (Women on Musical Bedrest)
Overview
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
- Behavioral Music Therapy Intervention
Music Therapy Sessions. There will be 4 scheduled music therapy sessions, and a postpartum follow up.
Primary outcome measures
- Measure the length of time from when the membranes prematurely rupture to delivery [Time frame: 30 days]
Secondary outcome measures (7)
- Change in anxiety levels in relation to the length of hospital stay [Time frame: 30 days]
- Music therapy in relation to maternal tachycardia due to stress [Time frame: 30 days]
- Edinburgh Postnatal Depression Scale score before and after music therapy [Time frame: 30 days]
- Visual analogue scale for anxiety before and after music therapy [Time frame: 30 days]
- Music therapy in relation to infant bonding [Time frame: 30 days]
- Change in the time interval between delivery and newborn receiving their mother's breastmilk [Time frame: 30 days]
- Change in blood pressure before and after music therapy [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- Pregnant women between 18 and 64 years of age.
- Singleton pregnancy.
- Hospital admission due to a high risk of premature delivery.
- Confirmed diagnosis of preterm premature rupture of membranes.
- Length of stay in the hospital for 48 hours or more and stable for 48 hours or more.
- Patients willing to listen to music.
- Patients willing to participate throughout all the music therapy sessions and the postpartum follow-up visit.
Exclusion criteria
- Hospital length of stay of less than 48 hours.
- Non-singleton pregnancy Gravidae with severe medical and or surgical complications during their hospital admission that prevents them from participating in Music Therapy sessions.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Texas Children's Pavilion for Women — Houston
Publications
- 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. PMID 31274510
- 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.
- 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. PMID 19713801
Identifiers
NCT: NCT05893485 · H-52059