An interventional study of Music Therapy Intervention in Music Therapy and Preterm Premature Rupture of Membrane (PPROM), sponsored by Christina Chianis Reed. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Christina Chianis Reed · Not applicable, Interventional, and Prevention
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Among 26 studies in Preterm Premature Rupture of the Membranes with a site in United States — 7 open to participants now, 9 under way, 1 of them phase 3. Preterm Premature Rupture of the Membranes · United States.
Among the 26 studies in Preterm Premature Rupture of the Membranes with a site in United States, this one is the 8th largest by planned enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2023, is one of 8 with no phase, and was the 20th registered.
75 studies on the registry are indexed under Preterm Premature Rupture of the Membranes; 17 are open to participants now.
Browse Preterm Premature Rupture of the Membranes studies →7 of the 26 studies in Preterm Premature Rupture of the Membranes with a site in United States are open now. Recruiting first, the newest first:
Alexa Henderson · Sites in United States
Women only
Eastern Virginia Medical School · Sites in United States
Ages 18–50 · Women only
Ohio State University · Sites in United States
Ages 18+ · Women only
Washington University School of Medicine · Sites in United States
Women only · Healthy volunteers
Woman's · Sites in United States
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Preterm Premature Rupture of the Membranes studies recruiting now, 7 (64%) set no upper age limit and 4 (36%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 64 Years · female · no healthy volunteers.
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26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 3 · Phase 4 7
First in 2004; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 95 across 49 interventional studies indexed under Preterm Premature Rupture of the Membranes.
Median enrollment 48 across the 20 interventional studies, 254 across the 6 observational. Of the 14 that completed or were terminated, 4 (29%) have results posted.
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4 of 26 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Christina Chianis Reed as lead sponsor.
Christina Chianis Reed has 1 study filed under Preterm Premature Rupture of the Membranes — fewer than ten, so there is no comparison to draw.
2 of the studies in Preterm Premature Rupture of the Membranes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06396078Ohio State UniversityImprovement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT) | 2026-12 |
| NCT05773014Washington University School of MedicineDigital vs. Speculum Exams for PPROM | 2027-03-01 |
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Among the 26 studies in Preterm Premature Rupture of the Membranes with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
The investigators will identify and screen patients who are admitted to the Texas Children's Pavilion for Women and Houston Methodist Willowbrook with a clinical diagnosis of threatened preterm birth caused by preterm premature rupture of membranes (PPROM), between a gestational age of 24 and 36 weeks. The investigators will approach the patients to discuss this study and if they are interested in participating, the investigators will provide the informed consent form for their signature. After that, the investigators will start collecting data, such as basic demographic information and the Edinburgh Postnatal Depression Scoring scale (EDPS) scores that are clinically taken before and after the PPROM diagnosis.
Inclusion Criteria:
Exclusion Criteria:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No Music Therapy
Four music therapy sessions provided prior to delivery.
Behavioral: Music Therapy Intervention
Music Therapy Sessions. There will be 4 scheduled music therapy sessions, and a postpartum follow up.
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.
Time frame: 30 days
Change in anxiety levels in relation to the length of hospital stay
Determine if there is a relationship between anxiety levels and hospital length of stay. The hospital length of stay is measured by hours spent in-patient at the hospital. Anxiety levels will be assessed using the Visual Analogue Scale for Anxiety. The Visual Analogue Scale for Anxiety is a 10 centimeter line with the minimum score of "not at all anxious" to the left and the maximum score of "very anxious" to the right. The more anxious a person is they put a mark on closer to "very anxious" which is the worse outcome.
Time frame: 30 days
Music therapy in relation to maternal tachycardia due to stress
Determine if music therapy sessions change heart rate on tachycardic women with reported stress.
Time frame: 30 days
Edinburgh Postnatal Depression Scale score before and after music therapy
Evaluate the Edinburgh Postnatal Depression Scale scores before and after music therapy. The minimum score is 0 and the maximum score is 30. Possible depression is 10 or greater. Greater the score the worse the outcome. Always look at question number 10 regarding suicidal thoughts.
Time frame: 30 days
Visual analogue scale for anxiety before and after music therapy
Correlate the Visual Analogue Scale measuring the state anxiety (VAS-A) scores both antepartum and postpartum in patients who receive music therapy. The Visual Analogue Scale for Anxiety is a 10 centimeter line with the minimum score of "not at all anxious" to the left and the maximum score of "very anxious" to the right. The more anxious a person is they put a mark on closer to "very anxious" which is the worse outcome.
Time frame: 30 days
Music therapy in relation to infant bonding
Participants express increased connection/bonding with their infant through a questionnaire given to them at their 6 week postpartum visit. The question has yes or no answers. The participant will choose yes if they feel an increased connection/bonding with their infant and participants will choose no if they do not feel an increased connection/bonding with their infant. The answer choice no is the worse outcome.
Time frame: 30 days
Change in the time interval between delivery and newborn receiving their mother's breastmilk
Change in the time interval between delivery and newborn receiving their mother's breastmilk normalized to gestational age at delivery.
Time frame: 30 days
Change in blood pressure before and after music therapy
Measure blood pressure at pre-determined times before and after music therapy. Higher blood pressure is a worse outcome.
Time frame: 30 days
Plan to share: No
Started May 2023 (actual). Primary completion is estimated for Mar 2026, 33 months after the start.
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