Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

This study has been completed.
Sponsor:
Collaborators:
Maternidade Escola da UFRJ
Instituto de Puericultura e Pediatria Martagão Gesteira
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00930761
First received: June 29, 2009
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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 Intervention
Breastfeeding
Behavioral: Music therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Maternal Breastfeeding at Infant Discharge [ Time Frame: At the time of the infant hospital discharge ] [ Designated as safety issue: No ]
  • Maternal Breastfeeding 7-15 Days After Discharge [ Time Frame: At the first follow-up visit (7-15 days after discharge) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal Breastfeeding at 30 Days After Discharge [ Time Frame: At 30 days after the infant hospital discharge ] [ Designated as safety issue: No ]
  • Maternal Breastfeeding at 60 Days After Discharge [ Time Frame: At 60 days after the infant hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: March 2004
Study Completion Date: October 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: June 29, 2009
Results First Received: July 8, 2009
Last Updated: October 13, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on July 23, 2014