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

Primary Purpose

Music Therapy, Preterm Premature Rupture of Membrane (PPROM)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy Intervention
Sponsored by
Christina Chianis Reed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Music Therapy focused on measuring Music therapy, Antepartum, Preterm Premature Rupture of Membranes (PPROM), Fetus, Woman, Post Traumatic Stress Disorder, Postpartum Depression, Anxiety, Stress

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Texas Children's Pavilion for WomenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Music Therapy Intervention

Arm Description

No Music Therapy

Four music therapy sessions provided prior to delivery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Music therapy in relation to maternal tachycardia due to stress
Determine if music therapy sessions change heart rate on tachycardic women with reported stress.
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.
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.
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.
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.
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.

Full Information

First Posted
January 17, 2023
Last Updated
May 29, 2023
Sponsor
Christina Chianis Reed
Collaborators
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05893485
Brief Title
Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus
Acronym
WOMB
Official Title
Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus, WOMB (Women on Musical Bedrest)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christina Chianis Reed
Collaborators
The Methodist Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music Therapy, Preterm Premature Rupture of Membrane (PPROM)
Keywords
Music therapy, Antepartum, Preterm Premature Rupture of Membranes (PPROM), Fetus, Woman, Post Traumatic Stress Disorder, Postpartum Depression, Anxiety, Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No Music Therapy
Arm Title
Music Therapy Intervention
Arm Type
Active Comparator
Arm Description
Four music therapy sessions provided prior to delivery.
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy Intervention
Intervention Description
Music Therapy Sessions. There will be 4 scheduled music therapy sessions, and a postpartum follow up.
Primary Outcome Measure Information:
Title
Measure the length of time from when the membranes prematurely rupture to delivery
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change in anxiety levels in relation to the length of hospital stay
Description
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.
Time Frame
30 days
Title
Music therapy in relation to maternal tachycardia due to stress
Description
Determine if music therapy sessions change heart rate on tachycardic women with reported stress.
Time Frame
30 days
Title
Edinburgh Postnatal Depression Scale score before and after music therapy
Description
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.
Time Frame
30 days
Title
Visual analogue scale for anxiety before and after music therapy
Description
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.
Time Frame
30 days
Title
Music therapy in relation to infant bonding
Description
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.
Time Frame
30 days
Title
Change in the time interval between delivery and newborn receiving their mother's breastmilk
Description
Change in the time interval between delivery and newborn receiving their mother's breastmilk normalized to gestational age at delivery.
Time Frame
30 days
Title
Change in blood pressure before and after music therapy
Description
Measure blood pressure at pre-determined times before and after music therapy. Higher blood pressure is a worse outcome.
Time Frame
30 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina C Reed, NP-BC
Phone
2817709027
Email
Christina.reed@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yamely Mendez Martinez, MD
Phone
832-826-7363
Email
Yamely.mendezmartinez@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Reed, WHNP-BC
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Pavilion for Women
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina C Reed, WHNP-BC
Phone
281-770-9027
Email
christina.reed@bcm.edu
First Name & Middle Initial & Last Name & Degree
Yamely Mendez Martinez, MD
Phone
832 8267363
Email
yamely.mendezmartinez@bcm.edu
First Name & Middle Initial & Last Name & Degree
Christina Reed, WHNP-BC
First Name & Middle Initial & Last Name & Degree
Yamely Mendez Martinez, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31274510
Citation
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.
Results Reference
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Citation
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.
Results Reference
background
PubMed Identifier
19713801
Citation
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.
Results Reference
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Learn more about this trial

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

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