Effectiveness of Music Therapy on the Development of Preterm Neonates

NCT02948491 | Unknown DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Pragmatic, randomized controlled clinical trial with blinding of the evaluator, performed in order to estimate the effectiveness, six (6) months after hospital discharge, of music therapy on the intra-hospital evolution and neurodevelopment of preterm neonates (gestational ages 28 to 37weeks) who are treated in Neonatal Intensive Care Units (NICU) in the Bucaramanga Metropolitan Area.

Conditions

Premature Birth

Keywords

Complementary Therapies; Neonate Intensive Care Units (NICU); Child Development; Infants Premature

Outcome Measures

Primary Outcomes (5)

• The Bayley-III Cognitive Scale

  The Bayley III scales of infant development in English, based on which a metric scale will be used with a mean of 100 and a standard deviation of 15, and a range from 40-160, for the following subscales

  six month

• The Bayley-III Motor Scale

  The Bayley III scales of infant development in English, based on which a metric scale will be used with a mean of 100 and a standard deviation of 15, and a range from 40-160, for the following subscales

  six months

• The Bayley-III Language Scale

  The Bayley III scales of infant development in English, based on which a metric scale will be used with a mean of 100 and a standard deviation of 15, and a range from 40-160, for the following subscales

  six months

• The Bayley-III Social-Emotional Scale

  Composite score equivalents available in order to total the score of each subscale.

  six months

• The Bayley-III Adaptive Behavior Scale

  The scores of all the skill areas are combined to create the infant's global measurement scale for the subscale corresponding to Adaptive development.

  six months

Secondary Outcomes (3)

• Heart rate

  Everyday during all the follow-up period in neonatal intensive care unit (an average of 1 month). Also, it will be measured while neonate is receiving the intervention

• Weight

  Everyday during all the follow-up period in neonatal intensive care unit (an average of 1 month).

• Blood pressure

  Everyday during all the follow-up period in neonatal intensive care unit (an average of 1 month).. Also, it will be measured while neonate is receiving the intervention

Study Arms (2)

Music therapy

EXPERIMENTAL

First. Recording of the voice of the mother singing the song to the child. (To choose this option, the song must be sung to the child during pregnancy at least 2 to 3 times per week. Second. The mother's favorite song, obtained externally. (To choose this option, the mother must bring the song that she that she listened to frequently, at least 5 times per week). Third. Pre-determined lullaby. (This option refers only to the lullaby melody or Brahms lullaby, edited to obtain stable volumes and normalization of the audio, with the effect of progressively appearing and fading for the first and last 10 seconds of the intervention with music therapy, so there are no drastic acoustic changes in the intervention. Audacity editing software will be used.)

Other: Music therapy

Without sound emission

NO INTERVENTION

The infant does not receive any sound emission because the baffle will be turned off. One of the three "intervention" options are chosen. The parents are told that their child may be randomly assigned to either the therapeutic or control group.

Interventions

Music therapy OTHER

Song that the mother sings to the child before birth, recording of the mother's voice.

Music therapy

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Belong to the group of neonates treated in neonatal intensive care units during the dates on which the sample will be taken.
• Clinical evaluation by the neonatologist indicating the infant's possible participation in the study.
• The neonate is between the gestational age of 28 and 37 weeks.

You may not qualify if:

• Mother is not able to give consent due to mental incapacity.

Sponsors & Collaborators

• Universidad Manuela Beltrán: lead
• Fundación Cardiovascular de Colombia: collaborator

Study Sites (1)

Universidad Manuela Beltran

Bucaramanga, Santander Department, 680006, Colombia

Location

Related Publications (10)

• Diggle P, Heagerty P, Liang KY, Zeger S. Analysis of Longitudinal Data. Second edition. Oxford, UK: Oxford University Press, 2013.

  BACKGROUND

• Loewy J. NICU music therapy: song of kin as critical lullaby in research and practice. Ann N Y Acad Sci. 2015 Mar;1337:178-85. doi: 10.1111/nyas.12648.

  PMID: 25773633 RESULT

• Standley JM, Cassidy J, Grant R, Cevasco A, Szuch C, Nguyen J, Walworth D, Procelli D, Jarred J, Adams K. The effect of music reinforcement for non-nutritive sucking on nipple feeding of premature infants. Pediatr Nurs. 2010 May-Jun;36(3):138-45.

  PMID: 20687305 RESULT

• Standley J. Music therapy research in the NICU: an updated meta-analysis. Neonatal Netw. 2012 Sep-Oct;31(5):311-6. doi: 10.1891/0730-0832.31.5.311.

  PMID: 22908052 RESULT

• Whitelaw A. Core Concepts: Intraventricular Hemorrhage NeoReviews 12 (2): e94-e10, 2011

  RESULT

• Auto FM, Amancio OM, Lanza FC. The effect of music on weight gain of preterm infants older than 32 weeks: a randomized clinical trial. Revista Paulista de Pediatria 33(4): e293-e299, 2015.

  RESULT

• Amini E, Rafiei P, Zarei K, Gohari M, Hamidi M. Effect of lullaby and classical music on physiologic stability of hospitalized preterm infants: a randomized trial. J Neonatal Perinatal Med. 2013 Jan 1;6(4):295-301. doi: 10.3233/NPM-1371313.

  PMID: 24441085 RESULT

• 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: 15996669 RESULT

• Macpherson H. Pragmatic clinical trials. Complement Ther Med. 2004 Jun-Sep;12(2-3):136-40. doi: 10.1016/j.ctim.2004.07.043.

  PMID: 15561524 RESULT

• Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13(2):217-24. doi: 10.31887/DCNS.2011.13.2/npatsopoulos.

  PMID: 21842619 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 28, 2016
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

CO (1)