NCT00930761

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
2 months until next milestone

Results Posted

Study results publicly available

August 19, 2009

Completed
Last Updated

October 15, 2009

Status Verified

October 1, 2009

Enrollment Period

3.3 years

First QC Date

June 29, 2009

Results QC Date

July 8, 2009

Last Update Submit

October 13, 2009

Conditions

Keywords

breast feedingmusic therapymaternal welfareinfant, newborn

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 INTERVENTION

Music therapy

EXPERIMENTAL
Behavioral: Music therapy

Interventions

Music therapyBEHAVIORAL

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.

Also known as: MT
Music therapy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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: 16171479BACKGROUND
  • 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. doi: 10.1111/j.0730-7659.2006.00090.x.

    PMID: 16732778BACKGROUND
  • 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. doi: 10.1002/pon.589.

    PMID: 12228871BACKGROUND
  • 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.

    PMID: 17695946BACKGROUND
  • 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. doi: 10.1093/jmt/28.4.180.

    PMID: 10160836BACKGROUND
  • 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. doi: 10.1097/DBP.0b013e31811ff8a7.

    PMID: 18049324BACKGROUND
  • 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.

    PMID: 18298503BACKGROUND
  • 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. doi: 10.1097/01.jnr.0000347637.02971.ec.

    PMID: 14579198BACKGROUND
  • Clark 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: 10252815BACKGROUND
  • 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.

    PMID: 18404877BACKGROUND
  • Ferrer 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: 17645387BACKGROUND
  • 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. doi: 10.1016/S0140-6736(03)13811-1.

    PMID: 12853204BACKGROUND
  • 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. doi: 10.2223/JPED.1473. Epub 2006 May 4.

    PMID: 16680285BACKGROUND
  • 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.

    PMID: 18355741BACKGROUND
  • 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. doi: 10.1177/104990910101800607.

    PMID: 11712719BACKGROUND
  • 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. doi: 10.1016/j.ijnurstu.2005.04.008. Epub 2005 Jul 5.

    PMID: 15996669BACKGROUND
  • 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. doi: 10.1097/BPO.0b013e3181558a4e.

    PMID: 17878794BACKGROUND
  • Phumdoung 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: 12836149BACKGROUND
  • 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.

    PMID: 8700604BACKGROUND
  • 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. doi: 10.1016/S0140-6736(03)13917-7.

    PMID: 12885488BACKGROUND
  • 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. doi: 10.1067/mhl.2001.118302.

    PMID: 11604980BACKGROUND
  • 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. doi: 10.1016/s0147-9563(03)00120-1.

    PMID: 14652528BACKGROUND
  • 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. doi: 10.1093/jmt/40.2.113.

    PMID: 14505443BACKGROUND
  • 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. doi: 10.1046/j.1365-2044.2003.03189_4.x.

    PMID: 12886915BACKGROUND
  • 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. doi: 10.1016/s0090-4295(02)02375-0.

    PMID: 12597931BACKGROUND
  • 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. doi: 10.1054/iccn.2001.1594.

    PMID: 11866419BACKGROUND
  • Lepage 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

Breast Feeding

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Arnaldo Prata Barbosa
Organization
Instituto de Puericultura e Pediatria Martagão Gesteira - UFRJ

Study Officials

  • Martha NS Vianna, MSc

    UFRJ (Universidade Federal do Rio de Janeiro) Maternidade Escola

    PRINCIPAL INVESTIGATOR
  • Arnaldo P Barbosa, MD, MSc, PhD

    UFRJ School of Medicine, Department of Pediatrics

    STUDY DIRECTOR
  • Albelino S Carvalhaes

    UFRJ Maternidade Escola

    STUDY CHAIR
  • Antonio LA Cunha, MD, MSc, PhD

    UFRJ School of Medicine, Department of Pediatrics

    STUDY CHAIR

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

Locations