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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Measure the length of time from when the membranes prematurely rupture to delivery [Срок оценки: 30 days]

Вторичные конечные точки (7)

• Change in anxiety levels in relation to the length of hospital stay [Срок оценки: 30 days]
• Music therapy in relation to maternal tachycardia due to stress [Срок оценки: 30 days]
• Edinburgh Postnatal Depression Scale score before and after music therapy [Срок оценки: 30 days]
• Visual analogue scale for anxiety before and after music therapy [Срок оценки: 30 days]
• Music therapy in relation to infant bonding [Срок оценки: 30 days]
• Change in the time interval between delivery and newborn receiving their mother's breastmilk [Срок оценки: 30 days]
• Change in blood pressure before and after music therapy [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Texas Children's Pavilion for Women — Houston

Публикации

• 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

Идентификаторы

NCT: NCT05893485 · H-52059

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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