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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Music Therapy; Preterm Premature Rupture of Membrane (PPROM)
• Intervention / Treatment: Behavioral: Music Therapy Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina C Reed, NP-BC; Phone Number: 2817709027; Email: Christina.reed@bcm.edu
• Study Contact Backup: Name: Yamely Mendez Martinez, MD; Phone Number: 832-826-7363; Email: Yamely.mendezmartinez@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Children's Pavilion for Women
      • Contact: Christina C Reed, WHNP-BC; Phone Number: 281-770-9027; Email: christina.reed@bcm.edu
      • Contact: Yamely Mendez Martinez, MD; Phone Number: 832 8267363; Email: yamely.mendezmartinez@bcm.edu
      • Principal Investigator: Christina Reed, WHNP-BC
      • Sub-Investigator: Yamely Mendez Martinez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Christina Chianis Reed
• Collaborators: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Christina Reed, WHNP-BC, Baylor College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Postpartum Depression; Anxiety; Stress; Music therapy; Post Traumatic Stress Disorder; Fetus; Antepartum; Woman; Preterm Premature Rupture of Membranes (PPROM)
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Rupture; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: H-52059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No