Music Therapy for Pain Management in the NICU Setting

NCT02434432 | Completed

• 1 other identifier: NUR.LB.02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Music therapy has been recommended as an adjuvant therapy for both preterm infants and mothers throughout their stay in the Neonatal Intensive Care Unit (NICU), and has been shown to have some beneficial effects, although conclusive evidence remains lacking. Objectives: To study the usefulness of two forms of music, as well as no music, on pain and physiological and behavioral parameters of preterm infants during a heel stick procedure for obtaining blood in the Neonatal Intensive Care Unit (NICU). Hypotheses: Infants hearing music chosen by their mothers will have less pain and optimal behavioral and physiologic responses as compared to infants who hear the lullaby or no music. Methods: An analytical observational study with a randomized cross-over design will be utilized. Inclusion will be stable infants born between 28 to 36 weeks of gestation, with normal hearing. Neonatal Physiologic responses \[heart rate (HR), oxygen saturation, (02 sat) and respiratory rate(RR)\] and Behavioral States will be recorded before and after the heel stick procedure. Maternal age, education, and pregnancy complications will be also be documented. Pain responses will be recorded using the Neonatal Pain, Agitation and Sedation Scale (NPASS). Ethical considerations: The study imposes minimal risk on infants. One potential risk is that the infant may become agitated while listening to music, especially if it is time for feeding. Based on previous research, infants tend to calm down while listening to music. However, in the infants who may be hungry or fussy, music exacerbate their agitation. To prevent this from occurring the investigators will not perform the heel stick close to feeding time and the investigators will be vigilantly timing and monitoring the infant's agitation. Because music has been shown to calm infants and stop them from crying, the benefits outweigh this risk. The heel stick is performed routinely on infants (often 3-6 times a day). The investigators will not perform any additional heel sticks for this study, but will rather intervene during one of the scheduled heel stick procedures.

Conditions

Music Therapy

Outcome Measures

Primary Outcomes (1)

• pain responses of preterm infants assessed on the NPASS

  During a heelstick procedure 5 minutes after the music conditions 1 & 2 or the control

Secondary Outcomes (2)

• Physiologic resposnes

  5 minutes before, during and five minutes after the heelstick

• Behavioral responses

  Recorded at 5 minutes before during and five minutes after the heelstick

Study Arms (3)

condition 1

EXPERIMENTAL

Infants in this arm will receive their mother's choice of music recorded on an Mp player and delivered via headphones.

Behavioral: music therapy selected by mothers

condition 2

ACTIVE COMPARATOR

Infants in this arm wil receive a recorded Lullaby music delivered to the infant via headphones.

Behavioral: Music therapy recorded lullaby

Condition 3

NO INTERVENTION

Infants in this arm will have the headphones applied but no music played.

Interventions

music therapy selected by mothers BEHAVIORAL

mothers' choice of music

Also known as: condition 1

condition 1

Music therapy recorded lullaby BEHAVIORAL

recorded lullaby

Also known as: condition 2

condition 2

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants will be included if they meet the following criteria: between 28 to 36 weeks gestational age, stable condition, not requiring any respiratory support, in an isolette or open crib, are at least one week post natal age and if their mothers have listened to music while pregnant.

You may not qualify if:

• Infant will be excluded if they are intubated and on a ventilator or high frequency ventilation, if they have a congenital anomaly that mainly affects hearing, such as craniofacial anomalies; and if they have brain anomalies associated with neurological disorders such as: grade 3-4 intraventricular hemorrhage and periventricular leukomalacia.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University Medical Center (AUBMC)

Beirut, Lebanon

Location

Related Publications (19)

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  PMID: 22709626 BACKGROUND

• Keith DR, Russell K, Weaver BS. The effects of music listening on inconsolable crying in premature infants. J Music Ther. 2009 Fall;46(3):191-203. doi: 10.1093/jmt/46.3.191.

  PMID: 19757875 BACKGROUND

• 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 BACKGROUND

• Alipour Z, Eskandari N, Ahmari Tehran H, Eshagh Hossaini SK, Sangi S. Effects of music on physiological and behavioral responses of premature infants: a randomized controlled trial. Complement Ther Clin Pract. 2013 Aug;19(3):128-32. doi: 10.1016/j.ctcp.2013.02.007. Epub 2013 May 9.

  PMID: 23890458 BACKGROUND

• Badr LK, Abdallah B, Hawari M, Sidani S, Kassar M, Nakad P, Breidi J. Determinants of premature infant pain responses to heel sticks. Pediatr Nurs. 2010 May-Jun;36(3):129-36.

  PMID: 20687304 BACKGROUND

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  PMID: 8700082 BACKGROUND

• Chen LC, Wu YC, Hsieh WS, Hsu CH, Leng CH, Chen WJ, Chiu NC, Lee WT, Yang MC, Fang LJ, Hsu HC, Jeng SF. The effect of in-hospital developmental care on neonatal morbidity, growth and development of preterm Taiwanese infants: a randomized controlled trial. Early Hum Dev. 2013 May;89(5):301-6. doi: 10.1016/j.earlhumdev.2012.10.008. Epub 2012 Nov 17.

  PMID: 23168303 BACKGROUND

• 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: 14579198 BACKGROUND

• Whipple J. The effect of music-reinforced nonnutritive sucking on state of preterm, low birthweight infants experiencing heelstick. J Music Ther. 2008 Fall;45(3):227-72. doi: 10.1093/jmt/45.3.227.

  PMID: 18959451 BACKGROUND

• Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.

  PMID: 23589814 BACKGROUND

• Cevasco AM, Grant RE. Effects of the pacifier activated lullaby on weight gain of premature infants. J Music Ther. 2005 Summer;42(2):123-39. doi: 10.1093/jmt/42.2.123.

  PMID: 15913390 BACKGROUND

• Yildiz A, Arikan D. The effects of giving pacifiers to premature infants and making them listen to lullabies on their transition period for total oral feeding and sucking success. J Clin Nurs. 2012 Mar;21(5-6):644-56. doi: 10.1111/j.1365-2702.2010.03634.x. Epub 2011 Jun 13.

  PMID: 21668549 BACKGROUND

• 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 BACKGROUND

• Bo LK, Callaghan P. Soothing pain-elicited distress in Chinese neonates. Pediatrics. 2000 Apr;105(4):E49. doi: 10.1542/peds.105.4.e49.

  PMID: 10742370 BACKGROUND

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  PMID: 11189668 BACKGROUND

• Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J. Enhanced kangaroo mother care for heel lance in preterm neonates: a crossover trial. J Perinatol. 2009 Jan;29(1):51-6. doi: 10.1038/jp.2008.113. Epub 2008 Sep 4.

  PMID: 18769382 BACKGROUND

• Hartling L, Shaik MS, Tjosvold L, Leicht R, Liang Y, Kumar M. Music for medical indications in the neonatal period: a systematic review of randomised controlled trials. Arch Dis Child Fetal Neonatal Ed. 2009 Sep;94(5):F349-54. doi: 10.1136/adc.2008.148411. Epub 2009 May 28.

  PMID: 19477913 BACKGROUND

• Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.

  PMID: 18165830 BACKGROUND

• Als H, Lawhon G, Brown E, Gibes R, Duffy FH, McAnulty G, Blickman JG. Individualized behavioral and environmental care for the very low birth weight preterm infant at high risk for bronchopulmonary dysplasia: neonatal intensive care unit and developmental outcome. Pediatrics. 1986 Dec;78(6):1123-32.

  PMID: 3786036 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 5, 2015
• Study Start: January 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 5, 2015

Record last verified: 2015-04

Locations

LE (1)