Clinical trial NCT00930761: Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns
Official title: A Randomized Controlled Trial to Evaluate the Effects of Music Therapy on Breastfeeding Rates Among Mothers of Premature Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: breast feeding
music therapy
maternal welfare
infant, newborn
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Maternidade Escola da UFRJ
name: Instituto de Puericultura e Pediatria Martagão Gesteira
First posted: 2009-06-30
Enrollment: 101
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal Breastfeeding at Infant Discharge
timeFrame: At the time of the infant hospital discharge
measure: Maternal Breastfeeding 7-15 Days After Discharge
timeFrame: At the first follow-up visit (7-15 days after discharge)
Secondary outcomes:
measure: Maternal Breastfeeding at 30 Days After Discharge
timeFrame: At 30 days after the infant hospital discharge
measure: Maternal Breastfeeding at 60 Days After Discharge
timeFrame: At 60 days after the infant hospital discharge
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: UFRJ Maternidade Escola
state: RJ
Study officials:
affiliation: UFRJ (Universidade Federal do Rio de Janeiro) Maternidade Escola
name: Martha NS Vianna, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UFRJ School of Medicine, Department of Pediatrics
name: Arnaldo P Barbosa, MD, MSc, PhD
role: STUDY_DIRECTOR
affiliation: UFRJ Maternidade Escola
name: Albelino S Carvalhaes
role: STUDY_CHAIR
affiliation: UFRJ School of Medicine, Department of Pediatrics
name: Antonio LA Cunha, MD, MSc, PhD
role: STUDY_CHAIR
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