Music Therapy for Prematurity

Overseen By Elizabeth Barone

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Genetic disorder, Hearing disorder, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention/silence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is music therapy safe for humans?

Music therapy is generally considered safe for humans. It is a noninvasive treatment that has been used to help manage pain, anxiety, and discomfort in various medical settings, including intensive care units and cancer treatment. ^{1 2 3 4 5}

How is music therapy different from other treatments for preterm infants?

Music therapy is unique because it uses live singing and instruments to create a calming environment, which can help reduce stress and improve oxygen levels and heart rate in preterm infants. Unlike other treatments, it provides a multi-sensory experience that supports brain development and relaxation in the noisy environment of the NICU. ^{6 7 8 9 10}

What data supports the effectiveness of this treatment for prematurity?

Research shows that music therapy can help improve the hospital experience by reducing pain and anxiety, and enhancing well-being in various medical settings, including for preterm infants in the NICU (neonatal intensive care unit). ^{2 4 9 11 12}

Who Is on the Research Team?

Joanne V Loewy, DA, MT-BC, LCAT

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for preterm infants born at 24-37 weeks' gestation, considered appropriate for music therapy, and without genetic disorders or hearing issues. It's not suitable for extremely fragile infants unlikely to survive 24 hours or those of uncertain viability.

Inclusion Criteria

My newborn is recommended for music therapy based on their health condition.

My newborn was born prematurely between 24-37 weeks at Mount Sinai.

Exclusion Criteria

I have a diagnosed hearing disorder.

I have a diagnosed genetic disorder.

Infant of uncertain viability (gestation <23 weeks, birth weight <500 grams)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive six intervention days over a two-week period, with 3 sessions per week, involving ocean disc music therapy and control conditions

2 weeks

6 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cerebral oxygen saturation measurements

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Music Therapy

Trial Overview The study tests the effects of ocean disc music therapy on respiratory stability and brain oxygen levels in premature babies. Infants are randomly assigned to receive either this intervention or no sound, with sessions three times a week over two weeks.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

Participants in this group will receive the ocean disc music therapy entrainment intervention

Group II: Control group Active Control 1 Intervention

Participants in this group will not receive any intervention

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

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]

Music therapy can significantly enhance the hospital experience for patients, suggesting it may have beneficial effects on their overall well-being during treatment.

The review synthesizes current research, indicating that incorporating music therapy into hospital care could lead to improved patient satisfaction and emotional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of music therapy on patients' perception and manifestation of pain, anxiety, and patient satisfaction. Richards, T., Johnson, J., Sparks, A., et al.[2015]

A meta-analysis of 183 studies across 11 medical specialties found that music therapy interventions have significantly greater positive effects on outcomes like pain, well-being, mood, and nausea/vomiting compared to music medicine interventions.

The analysis particularly highlighted benefits for patients with cancer, those who are terminally ill, and patients with HIV, indicating that music therapy can be an effective complementary treatment in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music and music therapy on medical patients: a meta-analysis of the research and implications for the future. Dileo, C.[2022]

A national clinical practice review in Australia highlighted the role of music therapy in managing symptoms for children with cancer, indicating its potential benefits in pediatric oncology settings.

Feedback from patients and families at a major pediatric hospital suggests that music therapy services are valuable, prompting recommendations for further research and professional development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy services in pediatric oncology: a national clinical practice review. Tucquet, B., Leung, M.[2018]

In a study involving 259 pediatric patients in the intensive care unit, live music therapy significantly reduced heart rates, breathing rates, and levels of discomfort during the sessions.

The findings suggest that music therapy could be an effective nonpharmacological intervention to help manage pain and anxiety in critically ill children, despite its limited current use in PICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a live music therapy intervention on critically ill paediatric patients in the intensive care unit: A quasi-experimental pretest-posttest study. Mata Ferro, M., Falcó Pegueroles, A., Fernández Lorenzo, R., et al.[2023]

Music therapy serves as a complementary treatment for critically ill patients in intensive care, enhancing the effects of conventional medical treatments.

The intervention has both physiological and psychological benefits, suggesting it can improve overall patient well-being during critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in ICU. Coughlan, A.[2015]

Music therapy is a noninvasive and cost-effective intervention that can effectively reduce heart rate, blood pressure, anxiety, and pain in patients.

The review highlights the historical and theoretical foundations of music therapy, suggesting its potential to improve patient outcomes across various clinical settings and emphasizing the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music as intervention: a notable endeavor to improve patient outcomes. White, JM.[2022]

A review of 12 clinical studies involving 922 cancer patients indicates that music therapy can lead to short-term improvements in mood, relaxation, and reductions in anxiety and pain, particularly in pediatric oncology settings.

Case vignettes illustrate that music therapy can help patients express emotions and shift focus from their illness to a healthier mindset, suggesting its potential as a supportive treatment in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. Boyde, C., Linden, U., Boehm, K., et al.[2020]

This pilot trial involves 60 preterm infants under 32 weeks gestational age, testing the effects of creative music therapy (CMT) on brain development during their neonatal intensive care, with assessments planned at 24 months and 5 years.

The study aims to explore the feasibility and potential efficacy of CMT as a low-cost, low-risk intervention that could support brain development in preterm infants, potentially leading to significant clinical benefits if proven effective in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol. Haslbeck, FB., Bucher, HU., Bassler, D., et al.[2023]

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]

Music therapy (MT) for preterm infants in the neonatal intensive care unit (NICU) has shown to significantly reduce heart rate and respiratory rate, and decrease maternal anxiety, based on a meta-analysis of 14 randomized trials.

While MT appears to improve short-term physiological parameters and feeding volume, the evidence is of low to very low certainty, and there are no reported long-term safety or neurodevelopmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for preterm neonates in the neonatal intensive care unit: An overview of systematic reviews. Mohan, A., Gokulakrishnan, G., El-Saie, A., et al.[2021]

Music therapy, specifically live singing accompanied by a pentatonic harp, has been shown to significantly reduce stress in premature infants in a neonatal unit, as evidenced by their more relaxed demeanor.

The therapy also led to measurable improvements in health indicators, including increased oxygen saturation levels and reduced heart rates in infants born between 23 and 36 weeks of gestation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Singing for preterm born infants music therapy in neonatology]. Desquiotz-Sunnen, N.[2013]

Citations

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

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

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

The effect of music therapy on patients' perception and manifestation of pain, anxiety, and patient satisfaction. [2015]

3. Canada pubmed.ncbi.nlm.nih.gov

Effects of music and music therapy on medical patients: a meta-analysis of the research and implications for the future. [2022]

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

Music therapy services in pediatric oncology: a national clinical practice review. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

The effect of a live music therapy intervention on critically ill paediatric patients in the intensive care unit: A quasi-experimental pretest-posttest study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Music therapy in ICU. [2015]

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

Music as intervention: a notable endeavor to improve patient outcomes. [2022]

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

The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol. [2023]

10. Israel pubmed.ncbi.nlm.nih.gov

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

11. Norway pubmed.ncbi.nlm.nih.gov

Music therapy for preterm neonates in the neonatal intensive care unit: An overview of systematic reviews. [2021]

12. Luxembourg pubmed.ncbi.nlm.nih.gov

[Singing for preterm born infants music therapy in neonatology]. [2013]