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Completed

NCT Number: NCT00930761

Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

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.

Completed

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UFRJ Maternidade Escola

Rio de Janeiro, 22240-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy

Behavioral

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.

Other names: MT

Primary outcomes

  1. Maternal Breastfeeding at Infant Discharge

    Time frame: At the time of the infant hospital 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).

  2. Maternal Breastfeeding 7-15 Days After Discharge

    Time frame: At the first follow-up visit (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).

Secondary outcomes

  1. Maternal Breastfeeding at 30 Days After Discharge

    Time frame: At 30 days after the infant hospital 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).

  2. Maternal Breastfeeding at 60 Days After Discharge

    Time frame: At 60 days after the infant hospital 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).

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Instituto de Puericultura e Pediatria Martagão Gesteira
  • Maternidade Escola da UFRJ

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 30, 2009
Registry last updated
Oct 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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