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

NCT05893485 | Recruiting

• 1 other identifier: H-52059
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• Edinburgh Postnatal Depression Scale score before and after music therapy

  30 days

• Visual analogue scale for anxiety before and after music therapy

  30 days

• Music therapy in relation to infant bonding

  30 days

Study Arms (2)

Control

NO INTERVENTION

No Music Therapy

Music Therapy Intervention

ACTIVE COMPARATOR

Four music therapy sessions provided prior to delivery.

Behavioral: Music Therapy Intervention

Interventions

Music Therapy Intervention BEHAVIORAL

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

Music Therapy Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christina Chianis Reed: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Texas Children's Pavilion for Women

Houston, Texas, 77030, United States

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Stress Disorders, Post-Traumatic; Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders

Study Officials

• Christina Reed, WHNP-BC

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina C Reed, NP-BC

CONTACT

2817709027; Christina.reed@bcm.edu

Yamely Mendez Martinez, MD

CONTACT

832-826-7363; Yamely.mendezmartinez@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of OB/GYN, Dir of Ops Placenta Accreta Care Team, and Dir of Clinical Research

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: June 8, 2023
• Study Start: May 15, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)