Back to results

Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

Primary Purpose

Breastfeeding

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Music therapy

About this trial

This is an interventional prevention trial for Breastfeeding focused on measuring breast feeding, music therapy, maternal welfare, infant, newborn

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

UFRJ Maternidade Escola

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Music therapy

Arm Description

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

Maternal Breastfeeding at 30 Days After Discharge

Maternal Breastfeeding at 60 Days After Discharge

Full Information

NCT ID

NCT00930761

First Posted

June 29, 2009

Last Updated

October 13, 2009

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Maternidade Escola da UFRJ, Instituto de Puericultura e Pediatria Martagão Gesteira

1. Study Identification

Unique Protocol Identification Number

NCT00930761

Brief Title

Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Maternidade Escola da UFRJ, Instituto de Puericultura e Pediatria Martagão Gesteira

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breastfeeding

Keywords

breast feeding, music therapy, maternal welfare, infant, newborn

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Title

Music therapy

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Music therapy

Other Intervention Name(s)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maternal Breastfeeding at Infant Discharge

Description

Time Frame

At the time of the infant hospital discharge

Title

Maternal Breastfeeding 7-15 Days After Discharge

Description

Time Frame

At the first follow-up visit (7-15 days after discharge)

Secondary Outcome Measure Information:

Title

Maternal Breastfeeding at 30 Days After Discharge

Description

Time Frame

At 30 days after the infant hospital discharge

Title

Maternal Breastfeeding at 60 Days After Discharge

Description

Time Frame

At 60 days after the infant hospital discharge

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martha NS Vianna, MSc

Organizational Affiliation

UFRJ (Universidade Federal do Rio de Janeiro) Maternidade Escola

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arnaldo P Barbosa, MD, MSc, PhD

Organizational Affiliation

UFRJ School of Medicine, Department of Pediatrics

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Albelino S Carvalhaes

Organizational Affiliation

UFRJ Maternidade Escola

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Antonio LA Cunha, MD, MSc, PhD

Organizational Affiliation

UFRJ School of Medicine, Department of Pediatrics

Official's Role

Study Chair

Facility Information:

Facility Name

UFRJ Maternidade Escola

City

Rio de Janeiro

State/Province

ZIP/Postal Code

22240-001

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

16171479

Citation

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.

Results Reference

background

PubMed Identifier

16732778

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. doi: 10.1111/j.0730-7659.2006.00090.x.

Results Reference

background

PubMed Identifier

12228871

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. doi: 10.1002/pon.589.

Results Reference

background

PubMed Identifier

17695946

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.

Results Reference

background

PubMed Identifier

10160836

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. doi: 10.1093/jmt/28.4.180.

Results Reference

background

PubMed Identifier

18049324

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. doi: 10.1097/DBP.0b013e31811ff8a7. Erratum In: J Dev Behav Pediatr. 2009 Jun;30(3):254. Abeti, Mariana Scollo [corrected to Scollo Abeti, Marianna].

Results Reference

background

PubMed Identifier

18298503

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.

Results Reference

background

PubMed Identifier

14579198

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. doi: 10.1097/01.jnr.0000347637.02971.ec.

Results Reference

background

PubMed Identifier

10252815

Citation

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.

Results Reference

background

PubMed Identifier

18404877

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.

Results Reference

background

PubMed Identifier

17645387

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. doi: 10.1093/jmt/44.3.242.

Results Reference

background

PubMed Identifier

12853204

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. doi: 10.1016/S0140-6736(03)13811-1.

Results Reference

background

PubMed Identifier

16680285

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. doi: 10.2223/JPED.1473. Epub 2006 May 4.

Results Reference

background

PubMed Identifier

18355741

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.

Results Reference

background

PubMed Identifier

11712719

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. doi: 10.1177/104990910101800607.

Results Reference

background

PubMed Identifier

15996669

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. doi: 10.1016/j.ijnurstu.2005.04.008. Epub 2005 Jul 5.

Results Reference

background

PubMed Identifier

17878794

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. doi: 10.1097/BPO.0b013e3181558a4e.

Results Reference

background

PubMed Identifier

12836149

Citation

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.

Results Reference

background

PubMed Identifier

8700604

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.

Results Reference

background

PubMed Identifier

12885488

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. doi: 10.1016/S0140-6736(03)13917-7.

Results Reference

background

PubMed Identifier

11604980

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. doi: 10.1067/mhl.2001.118302.

Results Reference

background

PubMed Identifier

14652528

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. doi: 10.1016/s0147-9563(03)00120-1.

Results Reference

background

PubMed Identifier

14505443

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. doi: 10.1093/jmt/40.2.113.

Results Reference

background

PubMed Identifier

12886915

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. doi: 10.1046/j.1365-2044.2003.03189_4.x.

Results Reference

background

PubMed Identifier

12597931

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. doi: 10.1016/s0090-4295(02)02375-0.

Results Reference

background

PubMed Identifier

11866419

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. doi: 10.1054/iccn.2001.1594.

Results Reference

background

PubMed Identifier

11574356

Citation

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.

Results Reference

background

Links:

URL

http://www.musictherapy.org/

Description

American Music Therapy Association

Learn more about this trial

Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

We'll reach out to this number within 24 hrs