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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

WOMB Trial 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.Check my eligibility

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.See study design

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.

WOMB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure the length of time from when the membranes prematurely rupture to delivery

Secondary outcome measures

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 more

WOMB 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Christina Chianis ReedLead Sponsor

The Methodist Hospital Research InstituteOTHER

274 Previous Clinical Trials

80,475 Total Patients Enrolled

1 Trials studying Music Therapy

16 Patients Enrolled for Music Therapy

Christina Reed, WHNP-BCPrincipal InvestigatorBaylor College of Medicine

Media Library

Music Therapy Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05893485 — N/A

Music Therapy Research Study Groups: Control, Music Therapy Intervention

Music Therapy Clinical Trial 2023: Music Therapy Intervention Highlights & Side Effects. Trial Name: NCT05893485 — N/A

Music Therapy Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05893485 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I participate in this experiment?

"The requirements for this study necessitate that applicants have prior experience with music therapy and are aged between 18-64. 60 individuals will be accepted into the trial."

Answered by AI

Does this research endeavor have an age limit for those wishing to partake?

"The eligibility requirements for this study necessitate that participants are within the age bracket of 18 to 64. In contrast, there are 19 studies available for minors and 57 trials designed specifically for those 65 years old or above."

Answered by AI

What is the scope of participation in this clinical venture?

"Confirmed. According to clinicaltrials.gov, this study is actively searching for participants and has been since it was first posted on May 15th 2023; the latest edition was made on May 29th 2023. So far, 60 people have been recruited from one medical centre."

Answered by AI

Is enrollment still open to join this investigation?

"Due to the current status on clinicaltrials.gov, this study is actively recruiting patients. The initial posting was made on May 15th 2023 and has since been edited as of May 29th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Christina Chianis Reed 2023. "Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05893485.

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