Music Therapy for Premature Birth

(WOMB Trial)

Overseen By Yamely Mendez Martinez, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Christina Chianis Reed

Disqualifiers: Non-singleton pregnancy, Severe complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how music therapy can assist pregnant women at risk of preterm delivery. Researchers aim to determine if listening to music reduces stress, enhances maternal bonding, and possibly extends pregnancy duration. Participants will receive either four music therapy sessions or no music therapy. The trial seeks women admitted to the hospital for high-risk pregnancies, specifically those planning to stay for at least 48 hours and willing to listen to music. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could improve maternal and fetal health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that music therapy is safe for antepartum mothers?

Research has shown that music therapy is safe and easy to manage. Studies have found that it can reduce anxiety in pregnant women and improve the birth weight of their babies. One study discovered that music therapy helped infants in intensive care feel less pain and calm down faster. This suggests that music therapy can gently and effectively support both mothers and babies without causing harm. Overall, music therapy is considered a safe and non-invasive treatment option. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about music therapy for premature birth because it offers a non-invasive, drug-free approach to support infant development. Unlike traditional treatments that may involve medication or specialized medical equipment, music therapy focuses on the soothing power of sound to potentially improve outcomes for premature infants. This approach aims to enhance brain development and emotional well-being through structured musical sessions, providing a gentle and comforting intervention that could complement existing medical care.

What evidence suggests that music therapy is effective for improving coping and bonding in high-risk pregnancies?

Research shows that music therapy can help preterm infants manage pain and stress. Studies have found that music eases pain, improves oxygen levels, and stabilizes heart rates in these babies. This calming effect helps them handle the challenges of the neonatal intensive care unit (NICU). In this trial, some participants will receive music therapy sessions before delivery. Although limited research exists on music therapy for pregnant mothers, these findings suggest it might reduce stress and improve bonding. Music therapy could help mothers develop positive coping habits and connect with their babies before birth. ^{3 5 6 7 8}

Who Is on the Research Team?

Christina Reed, WHNP-BC

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a pregnant woman aged between 18 and 64.

Singleton pregnancy

Hospital admission due to a high risk of premature delivery

Exclusion Criteria

Non-singleton pregnancy

My hospital stay was under 48 hours.

I cannot join music therapy sessions due to severe health issues during my hospital stay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Music Therapy Intervention

Participants receive four music therapy sessions prior to delivery

4 weeks

4 sessions (in-person)

Follow-up

Participants are monitored for anxiety, infant bonding, and other outcomes postpartum

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Music Therapy Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

No Music Therapy

Group II: Music Therapy Intervention Active Control 1 Intervention

Four music therapy sessions provided prior to delivery.

Music Therapy Intervention is already approved in China, United States for the following indications:

Approved in China as Music Therapy for:

• Anxiety reduction in pregnant women
• Pain relief during labor
• Stress reduction in high-risk pregnancies

Approved in United States as Music Therapy for:

• Antepartum-related distress alleviation
• Improved caregiver-infant bonding
• Physiological stress reduction in infants post-partum

Who Is Running the Clinical Trial?

Christina Chianis Reed

Lead Sponsor

Trials

1

Recruited

60+

The Methodist Hospital Research Institute

Collaborator

Trials

299

Recruited

82,500+

Published Research Related to This Trial

Music therapy for preterm infants in the neonatal intensive care unit (NICU) shows a large significant effect size (Cohen's d = 0.82), indicating it is highly beneficial for their development and medical outcomes.

Live music therapy, especially when implemented early in the NICU stay for infants with very low birth weight (under 1,000 g) or extremely preterm (under 28 weeks), provides the greatest benefits, supporting its inclusion in best practice standards for NICU treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy research in the NICU: an updated meta-analysis. Standley, J.[2022]

In a study involving 40 preterm infants born before 32 weeks' gestation, live music therapy significantly improved vital signs, such as heart rate and oxygen saturation, regardless of whether physical contact was made during the sessions.

While physical contact during music therapy led to better baseline and post-therapy vital sign values, it did not enhance the overall response to the therapy, indicating that the benefits of music therapy for preterm infants are independent of physical touch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Physical Contact on Preterm Infants' Vital Sign Response to Live Music Therapy. Kobus, S., Diezel, M., Dewan, MV., et al.[2023]

A meta-analysis of music research involving premature infants in NICUs revealed a significant positive effect of music on their health, with an effect size of d = 0.83, indicating substantial benefits.

The study found that the benefits of music were consistent regardless of factors like gestational age, birthweight, or type of music delivery, suggesting that music therapy could be a valuable intervention for improving outcomes in premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the efficacy of music therapy for premature infants. Standley, JM.[2022]

Combining live harp music therapy with kangaroo care significantly reduces maternal anxiety in mothers of preterm infants in the NICU, with anxiety scores dropping from 46.8 to 27.7 (P < 0.01).

While the combined therapy improved maternal anxiety, it did not show any significant effects on the physiological responses or behavioral states of the preterm infants involved in the study of 52 mother-infant dyads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining kangaroo care and live harp music therapy in the neonatal intensive care unit setting. Schlez, A., Litmanovitz, I., Bauer, S., et al.[2011]

Premature infants experience unique challenges in sensory processing development, which can lead to sensory processing disorders.

Music therapy, when tailored to the developmental needs of premature infants, can be an effective intervention in the NICU, potentially reducing the risks of sensory processing disorders when combined with nursing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Sensory Processing in Premature Infants and Implications for Evidence-Based Music Therapy in the NICU. Pivovarnik, ES.[2022]

A study involving 213 families of premature infants evaluated the effects of music therapy on mother-infant bonding, parental anxiety, and maternal depression, but found no significant differences between the music therapy group and the standard care group at discharge.

Despite the music therapy sessions being well-received, with 98% of participants completing the treatment, the results indicated that parent-led singing did not improve bonding or reduce anxiety and depression among parents compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. Gaden, TS., Ghetti, C., Kvestad, I., et al.[2022]

In a study involving 126 mechanically ventilated patients in intensive care units, preferred music playlists were analyzed to understand their impact on managing anxiety through patient-directed music listening interventions.

The findings highlight the importance of music selection in therapeutic interventions, suggesting that involving a board-certified music therapist can enhance the effectiveness of music listening protocols in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. Heiderscheit, A., Johnson, K., Chlan, LL.[2023]

In a study involving 20 premature infants, music therapy significantly reduced physiological pain responses, such as heart rate, during and after blood sampling, indicating its potential as a non-invasive pain management strategy.

The infants exposed to music therapy showed less facial expression of pain and improved sleep-wake states compared to the control group, suggesting that music can effectively soothe and comfort premature infants during painful procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music therapy on pain responses induced by blood sampling in premature infants: A randomized cross-over trial. Shabani, F., Nayeri, ND., Karimi, R., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10880729/

The effect of music on pain management in preterm infants ... This systematic review demonstrated that music interventions are effective for relieving procedural pain in preterm infants.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876382018300520

Effect of music intervention on pain responses in premature ... The findings of this study show that music intervention is a safe and effective non-pharmacological intervention which increases the oxygen saturation and ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0316674

A systematic review and dose-response meta-analysis In our meta-analysis, we found that music therapy had a statistically significant effect on reducing pain and improving the behavioral state of premature ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02434432

Music Therapy for Pain Management in the NICU Setting Results showed a more rapid return to baseline heart rate, enhanced behavioral states and less pain in infants who listened to music (Butt & Kisilevsky, 2000).

5. mdpi.com mdpi.com/1660-4601/21/8/1018

Music Therapy with Preterm Infants and Their Families after ... Our results suggest that music therapy contributed to creating supportive physical and metaphorical environments for preterm infants and their families, in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9819311/

Music Therapy in Preterm Infants Reduces Maternal Distress Our results show that music therapy, primarily intended to promote physiological stability and potentially improve neurodevelopmental outcomes of preterm ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11412807/

Effect of music therapy on anxiety in full-term pregnant ... Music interventions have consistently shown positive effects on mental health and birth weight outcomes, specifically in reducing maternal ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05149677

The Effect of Music Therapy on Labour Pain, Anxiety, and ... Music therapy has been shown to be an effective, inexpensive, safe and non-invasive intervention for patients undergoing many non-obstetric ...