Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05893485
Status:
RECRUITING
Last Update Posted:
2023-06-08
First Post:
2023-01-17
Brief Title:
Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus
Sponsor:
Christina Chianis Reed
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus WOMB Women on Musical Bedrest
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WOMB
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
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
Detailed Description:
The investigators will identify and screen patients who are admitted to the Texas Childrens 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
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
3 Gravidae with severe medical and or surgical complications during their hospital admission that prevents them from participating in Music Therapy sessions
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
3 Gravidae with severe medical and or surgical complications during their hospital admission that prevents them from participating in Music Therapy sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None