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Music Therapy for Premature Birth (WOMB Trial)
N/A
Recruiting
Led By Christina Reed, WHNP-BC
Research Sponsored by Christina Chianis Reed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of music therapy on pregnant women at risk for preterm birth, to reduce stress and increase bonding with their baby.
Who is the study for?
This trial is for pregnant women aged 18-64 with a high risk of premature delivery, specifically those admitted to the hospital due to preterm premature rupture of membranes. Participants must be willing to listen to music and attend all therapy sessions plus a postpartum follow-up visit.
What is being tested?
The study tests if music therapy can help expectant mothers cope better, bond with their unborn child, and potentially extend pregnancy incubation time. It's exploring new ground by combining stress reduction, coping enhancement, and caregiver-infant bonding into one protocol before birth.
What are the potential side effects?
Music therapy is generally considered safe but may include emotional discomfort or distress during sessions. The trial aims to monitor any negative reactions closely as part of its safety measures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measure the length of time from when the membranes prematurely rupture to delivery
Secondary study objectives
Change in anxiety levels in relation to the length of hospital stay
Change in blood pressure before and after music therapy
Change in the time interval between delivery and newborn receiving their mother's breastmilk
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
No Music Therapy
Group II: Music Therapy InterventionActive Control1 Intervention
Four music therapy sessions provided prior to delivery.
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Who is running the clinical trial?
Christina Chianis ReedLead Sponsor
The Methodist Hospital Research InstituteOTHER
285 Previous Clinical Trials
81,626 Total Patients Enrolled
1 Trials studying Music Therapy
16 Patients Enrolled for Music Therapy
Christina Reed, WHNP-BCPrincipal InvestigatorBaylor College of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My hospital stay was under 48 hours.I cannot join music therapy sessions due to severe health issues during my hospital stay.I am a pregnant woman aged between 18 and 64.I've been in the hospital for at least 48 hours and have been stable for the same amount of time.I am willing to listen to music.I am willing to attend all music therapy sessions and the follow-up visit after giving birth.My water broke early, before 37 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Music Therapy Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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