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Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

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ClinicalTrials.gov Identifier: NCT00930761
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : August 19, 2009
Last Update Posted : October 15, 2009
Sponsor:
Collaborators:
Maternidade Escola da UFRJ
Instituto de Puericultura e Pediatria Martagão Gesteira
Information provided by:
Universidade Federal do Rio de Janeiro

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.


Condition or disease Intervention/treatment
Breastfeeding Behavioral: Music therapy

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Evaluate the Effects of Music Therapy on Breastfeeding Rates Among Mothers of Premature Newborns
Study Start Date : March 2004
Primary Completion Date : June 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Experimental: Music therapy Behavioral: Music therapy
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 Name: MT



Primary Outcome Measures :
  1. Maternal Breastfeeding at Infant Discharge [ Time Frame: At the time of the infant hospital discharge ]
  2. Maternal Breastfeeding 7-15 Days After Discharge [ Time Frame: At the first follow-up visit (7-15 days after discharge) ]

Secondary Outcome Measures :
  1. Maternal Breastfeeding at 30 Days After Discharge [ Time Frame: At 30 days after the infant hospital discharge ]
  2. Maternal Breastfeeding at 60 Days After Discharge [ Time Frame: At 60 days after the infant hospital discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930761


Locations
Brazil
UFRJ Maternidade Escola
Rio de Janeiro, RJ, Brazil, 22240-001
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Maternidade Escola da UFRJ
Instituto de Puericultura e Pediatria Martagão Gesteira
Investigators
Principal Investigator: Martha NS Vianna, MSc UFRJ (Universidade Federal do Rio de Janeiro) Maternidade Escola
Study Director: Arnaldo P Barbosa, MD, MSc, PhD UFRJ School of Medicine, Department of Pediatrics
Study Chair: Albelino S Carvalhaes UFRJ Maternidade Escola
Study Chair: Antonio LA Cunha, MD, MSc, PhD UFRJ School of Medicine, Department of Pediatrics

Additional Information:
Publications:

Responsible Party: Arnaldo P Barbosa, Department of Pediatris, UFRJ School of Medicine
ClinicalTrials.gov Identifier: NCT00930761     History of Changes
Other Study ID Numbers: MAME-21-2001
First Posted: June 30, 2009    Key Record Dates
Results First Posted: August 19, 2009
Last Update Posted: October 15, 2009
Last Verified: October 2009

Keywords provided by Universidade Federal do Rio de Janeiro:
breast feeding
music therapy
maternal welfare
infant, newborn

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications