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
1 other identifier
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedResults Posted
Study results publicly available
August 19, 2009
CompletedOctober 15, 2009
October 1, 2009
3.3 years
June 29, 2009
July 8, 2009
October 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maternal Breastfeeding at Infant 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).
At the time of the infant hospital discharge
Maternal Breastfeeding 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).
At the first follow-up visit (7-15 days after discharge)
Secondary Outcomes (2)
Maternal Breastfeeding at 30 Days After Discharge
At 30 days after the infant hospital discharge
Maternal Breastfeeding at 60 Days After Discharge
At 60 days after the infant hospital discharge
Study Arms (2)
Control
NO INTERVENTIONMusic therapy
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UFRJ Maternidade Escola
Rio de Janeiro, Rio de Janeiro, 22240-001, Brazil
Related Publications (27)
Al-Qahtani NH. Foetal response to music and voice. Aust N Z J Obstet Gynaecol. 2005 Oct;45(5):414-7. doi: 10.1111/j.1479-828X.2005.00458.x.
PMID: 16171479BACKGROUNDArnon 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. doi: 10.1111/j.0730-7659.2006.00090.x.
PMID: 16732778BACKGROUNDBarrera 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. doi: 10.1002/pon.589.
PMID: 12228871BACKGROUNDBerbel 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.
PMID: 17695946BACKGROUNDCaine 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. doi: 10.1093/jmt/28.4.180.
PMID: 10160836BACKGROUNDCaprilli S, Anastasi F, Grotto RP, Scollo Abeti M, 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. doi: 10.1097/DBP.0b013e31811ff8a7.
PMID: 18049324BACKGROUNDChang 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. doi: 10.1111/j.1365-2702.2007.02064.x. Epub 2008 Feb 19.
PMID: 18298503BACKGROUNDChou 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. doi: 10.1097/01.jnr.0000347637.02971.ec.
PMID: 14579198BACKGROUNDClark ME, McCorkle RR, Williams SB. Music therapy-assisted labor and delivery. J Music Ther. 1981 Summer;18(2):88-100. doi: 10.1093/jmt/18.2.88.
PMID: 10252815BACKGROUNDDesquiotz-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.
PMID: 18404877BACKGROUNDFerrer AJ. The effect of live music on decreasing anxiety in patients undergoing chemotherapy treatment. J Music Ther. 2007 Fall;44(3):242-55. doi: 10.1093/jmt/44.3.242.
PMID: 17645387BACKGROUNDJones 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. doi: 10.1016/S0140-6736(03)13811-1.
PMID: 12853204BACKGROUNDHatem 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. doi: 10.2223/JPED.1473. Epub 2006 May 4.
PMID: 16680285BACKGROUNDKlassen 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. doi: 10.1016/j.ambp.2007.12.005.
PMID: 18355741BACKGROUNDKrout 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. doi: 10.1177/104990910101800607.
PMID: 11712719BACKGROUNDLai 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. doi: 10.1016/j.ijnurstu.2005.04.008. Epub 2005 Jul 5.
PMID: 15996669BACKGROUNDLiu 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. doi: 10.1097/BPO.0b013e3181558a4e.
PMID: 17878794BACKGROUNDPhumdoung S, Good M. Music reduces sensation and distress of labor pain. Pain Manag Nurs. 2003 Jun;4(2):54-61. doi: 10.1016/s1524-9042(02)54202-8.
PMID: 12836149BACKGROUNDStandley JM, Moore RS. Therapeutic effects of music and mother's voice on premature infants. Pediatr Nurs. 1995 Nov-Dec;21(6):509-12, 574.
PMID: 8700604BACKGROUNDVictora 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. doi: 10.1016/S0140-6736(03)13917-7.
PMID: 12885488BACKGROUNDWong 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. doi: 10.1067/mhl.2001.118302.
PMID: 11604980BACKGROUNDEmery 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. doi: 10.1016/s0147-9563(03)00120-1.
PMID: 14652528BACKGROUNDHilliard 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. doi: 10.1093/jmt/40.2.113.
PMID: 14505443BACKGROUNDNilsson 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. doi: 10.1046/j.1365-2044.2003.03189_4.x.
PMID: 12886915BACKGROUNDYilmaz 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. doi: 10.1016/s0090-4295(02)02375-0.
PMID: 12597931BACKGROUNDHamel 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. doi: 10.1054/iccn.2001.1594.
PMID: 11866419BACKGROUNDLepage C, Drolet P, Girard M, Grenier Y, DeGagne R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6. doi: 10.1097/00000539-200110000-00022.
PMID: 11574356BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Arnaldo Prata Barbosa
- Organization
- Instituto de Puericultura e Pediatria Martagão Gesteira - UFRJ
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
March 1, 2004
Primary Completion
June 1, 2007
Study Completion
October 1, 2007
Last Updated
October 15, 2009
Results First Posted
August 19, 2009
Record last verified: 2009-10