Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

Breastfeeding Clinical Trial

Official title:

A Randomized Controlled Trial to Evaluate the Effects of Music Therapy on Breastfeeding Rates Among Mothers of Premature Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930761
• Other study ID #: MAME-21-2001
• Status: Completed
• Phase: N/A
• First received: June 29, 2009
• Last updated: October 13, 2009
• Start date: March 2004
• Est. completion date: October 2007

Study information

• Verified date: October 2009
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breastfeeding
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Brazil	UFRJ Maternidade Escola	Rio de Janeiro	RJ

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Instituto de Puericultura e Pediatria Martagão Gesteira, Maternidade Escola da UFRJ

Country where clinical trial is conducted

Brazil, 

References & Publications (27)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Caprilli 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. Erratum in: J Dev Behav Pediatr. 2009 Jun;30(3):254. Abeti, Mariana Scollo [corrected to Scollo Abeti, Marianna]. — View Citation

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. doi: 10.1111/j.1365-2702.2007.02064.x. Epub 2008 Feb 19. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1016/j.ambp.2007.12.005. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Breastfeeding at Infant Discharge		At the time of the infant hospital discharge	No
Primary	Maternal Breastfeeding 7-15 Days After Discharge		At the first follow-up visit (7-15 days after discharge)	No
Secondary	Maternal Breastfeeding at 30 Days After Discharge		At 30 days after the infant hospital discharge	No
Secondary	Maternal Breastfeeding at 60 Days After Discharge		At 60 days after the infant hospital discharge	No

External Links

•   American Music Therapy Association