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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Music Therapy for Premature Birth?

Research shows that music therapy in neonatal intensive care units (NICU) has significant benefits for premature infants, improving their overall well-being. It helps reduce pain during procedures and can stabilize vital signs, making it a valuable supportive treatment for these infants. ^{1 2 3 4 5}

Is music therapy safe for premature infants?

Research suggests that music therapy is generally safe for premature infants, as it can help stabilize vital signs and reduce pain during procedures. ^{1 2 3 5 6}

How is music therapy different from other treatments for premature birth?

Music therapy is unique because it uses sound to help stabilize vital signs and reduce pain in premature infants, unlike other treatments that may rely on medication or physical interventions. It can also enhance bonding between parents and infants, which is not typically addressed by standard medical treatments. ^{3 4 5 7 8}

Research Team

Christina Reed, WHNP-BC

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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

My hospital stay was under 48 hours.

Non-singleton pregnancy

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

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

3. India pubmed.ncbi.nlm.nih.gov

Effects of music therapy on pain responses induced by blood sampling in premature infants: A randomized cross-over trial. [2020]

4. Israel pubmed.ncbi.nlm.nih.gov

Combining kangaroo care and live harp music therapy in the neonatal intensive care unit setting. [2011]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Physical Contact on Preterm Infants' Vital Sign Response to Live Music Therapy. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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