Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
FEMALE
ID05893485

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

Led by Christina Chianis Reed · Updated on 2024-09-19

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Christina Chianis Reed

Lead Sponsor

T

The Methodist Hospital Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of music therapy on pregnant women admitted for long-term hospitalization due to high-risk pregnancies caused by preterm premature rupture of membranes (PPROM). The study aims to understand how music therapy might help mothers develop positive coping skills, improve bonding with their infant, and extend the time before delivery. This research also seeks to connect music therapy with stress reduction, coping, and caregiver-infant bonding during pregnancy, an area not previously studied under one protocol. Participants will be randomly assigned to either a control group with no music therapy or an intervention group receiving four scheduled music therapy sessions before delivery, plus a postpartum follow-up. The music therapy sessions are behavioral interventions designed to support mothers during their hospital stay, which must last at least 48 hours. The study includes only pregnant women between 18 and 64 years old with a single pregnancy and confirmed PPROM diagnosis. Throughout the study, researchers will collect demographic data and use several assessments like the Edinburgh Postnatal Depression Scale and visual analog scales to measure anxiety and stress levels. They will monitor maternal heart rate, blood pressure, infant bonding, and other outcomes related to the timing of delivery and breastfeeding initiation. The primary outcome is the length of time from membrane rupture to delivery, with evaluations occurring within 30 days. Participants will be followed through their hospital stay and a postpartum visit to assess the effects of music therapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 64Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 30 days until delivery

Participants undergo four scheduled music therapy sessions prior to delivery.

4 music therapy sessions

Postpartum Follow-up

Duration - Short-term after delivery

Participants have a follow-up visit after delivery to assess postpartum outcomes related to music therapy.

1 postpartum follow-up visit

Trial Site Locations

Total: 1 location

1

Texas Children's Pavilion for Women

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

C

Christina C Reed, NP-BC

Y

Yamely Mendez Martinez, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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