Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns - Full Text View

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:

MedlinePlus related topics: Breast Feeding

U.S. FDA Resources

Further study details as provided by Federal University of 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

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

Federal University of 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:

American Music Therapy Association This link exits the ClinicalTrials.gov site

Publications:

Al-Qahtani NH. Foetal response to music and voice. Aust N Z J Obstet Gynaecol. 2005 Oct;45(5):414-7.

Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6.

Barrera ME, Rykov MH, Doyle SL. The effects of interactive music therapy on hospitalized children with cancer: a pilot study. Psychooncology. 2002 Sep-Oct;11(5):379-88.

Berbel P, Moix J, Quintana S. [Music versus diazepam to reduce preoperative anxiety: a randomized controlled clinical trial] Rev Esp Anestesiol Reanim. 2007 Jun-Jul;54(6):355-8. Spanish.

Caine J. The effects of music on the selected stress behaviors, weight, caloric and formula intake, and length of hospital stay of premature and low birth weight neonates in a newborn intensive care unit. J Music Ther. 1991 Winter;28(4):180-92. Review.

Caprilli S, Anastasi F, Grotto RP, Abeti MS, Messeri A. Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study. J Dev Behav Pediatr. 2007 Oct;28(5):399-403.

Chang MY, Chen CH, Huang KF. Effects of music therapy on psychological health of women during pregnancy. J Clin Nurs. 2008 Oct;17(19):2580-7. Epub 2008 Feb 19.

Chou LL, Wang RH, Chen SJ, Pai L. Effects of music therapy on oxygen saturation in premature infants receiving endotracheal suctioning. J Nurs Res. 2003 Sep;11(3):209-16.

Clark ME, McCorkle RR, Williams SB. Music therapy-assisted labor and delivery. J Music Ther. 1981 Summer;18(2):88-100.

Desquiotz-Sunnen N. [Singing for preterm born infants music therapy in neonatology] Bull Soc Sci Med Grand Duche Luxemb. 2008;Spec No 1:131-43. French.

Ferrer AJ. The effect of live music on decreasing anxiety in patients undergoing chemotherapy treatment. J Music Ther. 2007 Fall;44(3):242-55.

Jones G, Steketee RW, Black RE, Bhutta ZA, Morris SS; Bellagio Child Survival Study Group. How many child deaths can we prevent this year? Lancet. 2003 Jul 5;362(9377):65-71. Review.

Hatem TP, Lira PI, Mattos SS. The therapeutic effects of music in children following cardiac surgery. J Pediatr (Rio J). 2006 May-Jun;82(3):186-92. Epub 2006 May 4.

Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. Review.

Krout RE. The effects of single-session music therapy interventions on the observed and self-reported levels of pain control, physical comfort, and relaxation of hospice patients. Am J Hosp Palliat Care. 2001 Nov-Dec;18(6):383-90.

Lai HL, Chen CJ, Peng TC, Chang FM, Hsieh ML, Huang HY, Chang SC. Randomized controlled trial of music during kangaroo care on maternal state anxiety and preterm infants' responses. Int J Nurs Stud. 2006 Feb;43(2):139-46. Epub 2005 Jul 5.

Liu RW, Mehta P, Fortuna S, Armstrong DG, Cooperman DR, Thompson GH, Gilmore A. A randomized prospective study of music therapy for reducing anxiety during cast room procedures. J Pediatr Orthop. 2007 Oct-Nov;27(7):831-3.

Phumdoung S, Good M. Music reduces sensation and distress of labor pain. Pain Manag Nurs. 2003 Jun;4(2):54-61.

Standley JM, Moore RS. Therapeutic effects of music and mother's voice on premature infants. Pediatr Nurs. 1995 Nov-Dec;21(6):509-12, 574.

Victora CG, Wagstaff A, Schellenberg JA, Gwatkin D, Claeson M, Habicht JP. Applying an equity lens to child health and mortality: more of the same is not enough. Lancet. 2003 Jul 19;362(9379):233-41.

Wong HL, Lopez-Nahas V, Molassiotis A. Effects of music therapy on anxiety in ventilator-dependent patients. Heart Lung. 2001 Sep-Oct;30(5):376-87.

Emery CF, Hsiao ET, Hill SM, Frid DJ. Short-term effects of exercise and music on cognitive performance among participants in a cardiac rehabilitation program. Heart Lung. 2003 Nov-Dec;32(6):368-73.

Hilliard RE. The effects of music therapy on the quality and length of life of people diagnosed with terminal cancer. J Music Ther. 2003 Summer;40(2):113-37.

Nilsson U, Rawal N, Unosson M. A comparison of intra-operative or postoperative exposure to music--a controlled trial of the effects on postoperative pain. Anaesthesia. 2003 Jul;58(7):699-703.

Yilmaz E, Ozcan S, Basar M, Basar H, Batislam E, Ferhat M. Music decreases anxiety and provides sedation in extracorporeal shock wave lithotripsy. Urology. 2003 Feb;61(2):282-6.

Hamel WJ. The effects of music intervention on anxiety in the patient waiting for cardiac catheterization. Intensive Crit Care Nurs. 2001 Oct;17(5):279-85.

Lepage C, Drolet P, Girard M, Grenier Y, DeGagné R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6.

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 Federal University of Rio de Janeiro:

breast feeding
music therapy
maternal welfare
infant, newborn

ClinicalTrials.gov processed this record on May 23, 2013