Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of music therapy on breastfeeding rates among mothers of premature newborns. Hypothesis: Music therapy applied to mothers of premature newborns increases the rates of maternal breastfeeding at the time of the infant hospital discharge and at follow-up visits.

Detailed Description
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Music therapy has been shown to have positive effects in several areas such as mental health, special education, rehabilitation and social development. Its use as a means to facilitate communication and expression of emotional contents was shown to be able to promote relief of anxiety, fears and tensions. However, in the maternal and child health area there are still few studies demonstrating the contribution of this therapy in the promotion of health and no study evaluating specifically the impact of this intervention on the rates of breastfeeding in mothers of premature newborns.

Official Title
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A Randomized Controlled Trial to Evaluate the Effects of Music Therapy on Breastfeeding Rates Among Mothers of Premature Newborns

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: Music therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mothers of premature newborns, with birth weight ≤ 1750 g that have reached clinical stability defined by the medical staff. To have signed an informed consent to participate in the study. Exclusion Criteria: Mothers that are HIV (Human Immunodeficiency Virus) positive. Mothers of neonates with clinical problems that impaired breast suction (encephalopathy with serious hypotonus, oro-facial anomalies, and heart problems). Mothers with severe hearing deficiencies. Exit Criteria: Mothers whose neonates died during the hospital stay. Mothers who, for any reason, had three or less music therapy sessions.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Music therapy<br> | Behavioral: Music therapy<br>* Music therapy sessions systematically offered to all mothers in the intervention group, three times a week, not mandatory, conducted by two music therapists in an appropriate room, during 60 minutes.<br>* Other names: MT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Breastfeeding at Infant Discharge | Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula). | At the time of the infant hospital discharge | 
| Maternal Breastfeeding 7-15 Days After Discharge | Maternal breastfeeding means: exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula). | At the first follow-up visit (7-15 days after discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Breastfeeding at 30 Days After Discharge | Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula). | At 30 days after the infant hospital discharge | 
| Maternal Breastfeeding at 60 Days After Discharge | Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula). | At 60 days after the infant hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast feeding, music therapy, maternal welfare, infant, newborn