Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus, WOMB (Women on Musical Bedrest)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Measure the length of time from when the membranes prematurely rupture to delivery
研究概览
简要总结
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.
详细描述
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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Measure the length of time from when the membranes prematurely rupture to delivery
时间窗: 30 days
Time 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.
次要结局
- Edinburgh Postnatal Depression Scale score before and after music therapy(30 days)
- Change in blood pressure before and after music therapy(30 days)
- Music therapy in relation to infant bonding(30 days)
- Change in anxiety levels in relation to the length of hospital stay(30 days)
- Music therapy in relation to maternal tachycardia due to stress(30 days)
- Visual analogue scale for anxiety before and after music therapy(30 days)
- Change in the time interval between delivery and newborn receiving their mother's breastmilk(30 days)
研究者
Christina Chianis Reed
Assistant Professor of OB/GYN, Dir of Ops Placenta Accreta Care Team, and Dir of Clinical Research
Baylor College of Medicine