Music TherapyWOMBNCT05893485
Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus
A study testing Music Therapy Intervention in people with Music Therapy and Preterm Premature Rupture of Membrane (PPROM), run by Christina Chianis Reed at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Music Therapy, Preterm Premature Rupture of Membrane (PPROM)
- What is being tested?
- Music Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Length of stay in the hospital for 48 hours or more and stable for 48 hours or more.
- Patients willing to listen to music.
- Patients willing to participate throughout all the music therapy sessions and the postpartum follow-up visit.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Children's Pavilion for Women
Houston, Texas, 77030
Christina C Reed, WHNP-BC, 281-770-9027, christina.reed@bcm.edu
Yamely Mendez Martinez, MD, 832 8267363, yamely.mendezmartinez@bcm.edu
About this study
Official title: Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus, WOMB (Women on Musical Bedrest)
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.
Read the detailed description
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:
- 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.
- Length of stay in the hospital for 48 hours or more and stable for 48 hours or more.
- Patients willing to listen to music.
- Patients willing to participate throughout all the music therapy sessions and the postpartum follow-up visit.
Exclusion Criteria:
- 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.
- Being tested
- Music Therapy Intervention
- Keywords
- Music therapy, Antepartum, Preterm Premature Rupture of Membranes (PPROM), Fetus, Woman, Post Traumatic Stress Disorder, Postpartum Depression, Anxiety, Stress
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Stress Disorders, Post-Traumatic, Depression, Postpartum, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Therapy InterventionBehavioural
Music Therapy Sessions. There will be 4 scheduled music therapy sessions, and a postpartum follow up.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No Music Therapy |
| Music Therapy Intervention | Active comparator | Four music therapy sessions provided prior to delivery. Receives: Behavioral: Music Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start15 May 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christina Chianis Reed
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, Christina Chianis Reed, Baylor College of Medicine
- Investigators
- Christina Reed, WHNP-BC, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893485
- Sponsor's protocol ID
- H-52059
- Acronym
- WOMB
- Status last verified
- Sep 2024
- First submitted
- 17 Jan 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corey K, Fallek R, Benattar M. Bedside Music Therapy for Women during Antepartum and Postpartum Hospitalization. MCN Am J Matern Child Nurs. 2019 Sep/Oct;44(5):277-283. doi: 10.1097/NMC.0000000000000557.
PubMed 31274510Teckenberg-Jansson P, Turunen S, Pölkki T, et al. Effects of live music therapy on heart rate variability and self-reported stress and anxiety among hospitalized pregnant women: A randomized controlled trial. Nordic Journal of Music Therapy. 2019; 28(1): 7-26.
Yang M, Li L, Zhu H, Alexander IM, Liu S, Zhou W, Ren X. Music therapy to relieve anxiety in pregnant women on bedrest: a randomized, controlled trial. MCN Am J Matern Child Nurs. 2009 Sep-Oct;34(5):316-23. doi: 10.1097/01.NMC.0000360425.52228.95.
PubMed 19713801
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Psychological Effects of Music Therapy in the Pregnant Woman and Fetus, WOMB (Women on Musical Bedrest)
- ClinicalTrials.gov ID
- NCT05893485
- Acronym / sponsor ID
- WOMB / H-52059
- Keywords
- Music therapy, Antepartum, Preterm Premature Rupture of Membranes (PPROM), Fetus, Woman, Post Traumatic Stress Disorder, Postpartum Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Christina Chianis ReedUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- Length of stay in the hospital for 48 hours or more and stable for 48 hours or more.
- Patients willing to listen to music.
- Patients willing to participate throughout all the music therapy sessions and the postpartum follow-up visit.
Exclusion Criteria:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No Music Therapy |
| Music Therapy Intervention | Active comparator | Behavioral: Music Therapy InterventionFour music therapy sessions provided prior to delivery. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
- Length of stay in the hospital for 48 hours or more and stable for 48 hours or more.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Therapy InterventionMusic Therapy Sessions. There will be 4 scheduled music therapy sessions, and a postpartum follow up. | Behavioural | Music Therapy Intervention |
Primary outcome
Measure the length of time from when the membranes prematurely rupture to delivery
Time frame: 30 days
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.
7 secondary outcomes
Change in anxiety levels in relation to the length of hospital stay
Time frame: 30 days
Music therapy in relation to maternal tachycardia due to stress
Time frame: 30 days
Edinburgh Postnatal Depression Scale score before and after music therapy
Time frame: 30 days
Visual analogue scale for anxiety before and after music therapy
Time frame: 30 days
Music therapy in relation to infant bonding
Time frame: 30 days
Change in the time interval between delivery and newborn receiving their mother's breastmilk
Time frame: 30 days
Change in blood pressure before and after music therapy
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31274510Corey K, Fallek R, Benattar M. Bedside Music Therapy for Women during Antepartum and Postpartum Hospitalization. MCN Am J Matern Child Nurs. 2019 Sep/Oct;44(5):277-283. doi: 10.1097/NMC.0000000000000557.
- BackgroundTeckenberg-Jansson P, Turunen S, Pölkki T, et al. Effects of live music therapy on heart rate variability and self-reported stress and anxiety among hospitalized pregnant women: A randomized controlled trial. Nordic Journal of Music Therapy. 2019; 28(1): 7-26.
- Background: PubMed 19713801Yang M, Li L, Zhu H, Alexander IM, Liu S, Zhou W, Ren X. Music therapy to relieve anxiety in pregnant women on bedrest: a randomized, controlled trial. MCN Am J Matern Child Nurs. 2009 Sep-Oct;34(5):316-23. doi: 10.1097/01.NMC.0000360425.52228.95.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Reed, WHNP-BC principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy Intervention in people with Music Therapy and Preterm Premature Rupture of Membrane (PPROM), run by Christina Chianis Reed at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina C Reed, NP-BC (2817709027, Christina.reed@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the length of time from when the membranes prematurely rupture to delivery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893485, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.