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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Music Therapy, Preterm Premature Rupture of Membrane (PPROM)

Intervention / Treatment
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* Behavioral: Music Therapy Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No Music Therapy | |
| Active Comparator: Music Therapy Intervention<br>Four music therapy sessions provided prior to delivery. | Behavioral: Music Therapy Intervention<br>* Music Therapy Sessions. There will be 4 scheduled music therapy sessions, and a postpartum follow up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the length of time from when the membranes prematurely rupture to delivery | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety levels in relation to the length of hospital stay | Determine 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. | 30 days | 
| Music therapy in relation to maternal tachycardia due to stress | Determine if music therapy sessions change heart rate on tachycardic women with reported stress. | 30 days | 
| Edinburgh Postnatal Depression Scale score before and after music therapy | Evaluate 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. | 30 days | 
| Visual analogue scale for anxiety before and after music therapy | Correlate 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. | 30 days | 
| Music therapy in relation to infant bonding | Participants 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. | 30 days | 
| Change in the time interval between delivery and newborn receiving their mother's breastmilk | Change in the time interval between delivery and newborn receiving their mother's breastmilk normalized to gestational age at delivery. | 30 days | 
| Change in blood pressure before and after music therapy | Measure blood pressure at pre-determined times before and after music therapy. Higher blood pressure is a worse outcome. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetus, Woman, Post Traumatic Stress Disorder, Postpartum Depression, Anxiety, Stress, Music therapy, Antepartum, Preterm Premature Rupture of Membranes (PPROM)