Recruiting

Music Therapy

Sponsor:

Christina Chianis Reed

Code:

NCT05893485

Conditions

Music Therapy

Preterm Premature Rupture of Membrane (PPROM)

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Music Therapy Intervention

Study Details

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)

Study ID

NCT05893485

Start date

May 15, 2023

Status verified date

Sep, 2024

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control

No Music Therapy

active comparator: Music Therapy Intervention

Four music therapy sessions provided prior to delivery.

Interventions

Music Therapy Intervention

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

Primary outcome measure

  • Measure the length of time from when the membranes prematurely rupture to delivery [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Christina C Reed, NP-BC

2817709027Christina.reed@bcm.edu

Yamely Mendez Martinez, MD

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

Locations

Texas Children's Pavilion for Women

Recruiting

Houston, Texas, United States, 77030

Contacts

Christina C Reed, WHNP-BC

281-770-9027christina.reed@bcm.edu

Yamely Mendez Martinez, MD

832 8267363yamely.mendezmartinez@bcm.edu

Principal Investigator:

Christina Reed, WHNP-BC

More Information

Sponsor

Christina Chianis Reed

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • Music therapy
  • Antepartum
  • Preterm Premature Rupture of Membranes (PPROM)
  • Fetus
  • Woman
  • Post Traumatic Stress Disorder
  • Postpartum Depression
  • Anxiety
  • Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christina Chianis Reed on 2024-09-19.