Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-64
SponsorChristina Chianis Reed
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Music Therapy Intervention
BehavioralMusic Therapy Sessions. There will be 4 scheduled music therapy sessions, and a postpartum follow up.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Music Therapy InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 days2
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 days3
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 days4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Christina Chianis Reed
Lead sponsor
Baylor College of Medicine
Sponsor institution
The Methodist Hospital Research Institute
Collaborator
Source ClinicalTrials.gov