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

June 29, 2009
October 13, 2009
March 2004
June 2007   (final data collection date for primary outcome measure)
  • 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 ]
rate of maternal breastfeeding [ Time Frame: at the time of the infant hospital discharge and at the first follow-up visit (between 7-15 days after discharge) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00930761 on ClinicalTrials.gov Archive Site
  • 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 ]
rate of maternal breastfeeding [ Time Frame: 30 and 60 days after the infant hospital discharge ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns
A Randomized Controlled Trial to Evaluate the Effects of Music Therapy on Breastfeeding Rates 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Breastfeeding
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
  • No Intervention: Control
  • Experimental: Music therapy
    Intervention: Behavioral: Music therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
October 2007
June 2007   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00930761
MAME-21-2001
No
Arnaldo P Barbosa, Department of Pediatris, UFRJ School of Medicine
Universidade Federal do Rio de Janeiro
  • Maternidade Escola da UFRJ
  • Instituto de Puericultura e Pediatria Martagão Gesteira
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
Universidade Federal do Rio de Janeiro
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP