The Effect of Lullaby Listened to Preterm Babies in Neonatal Intensive Care Units on Physiological Parameters and Pain

NCT05253625 | Unknown

• 1 other identifier: IzmirTinaztepeU NOzgurbuz
• Study Type: interventional
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preterms who enter a different environment after the intrauterine period experience an adaptation process and may need special care due to conditions such as developmental disabilities or neurological disorders. In such cases, newborns may frequently be exposed to repetitive painful interventions (like IV catherization). Pain in the postnatal period can cause physiological, behavioral and metabolic changes, and changes in the functional processing related with somatosensation and pain in the long term. In this context, inadequacy in pain control may cause neurodevelopmental and behavioral problems in infants. For these reasons, it is essential to carefully evaluate the pain status of the newborn and to perform pharmacological and/or non-pharmacological interventions. In the intrauterine 20th week, the ability to hear begins to form, and in the 26-28th weeks the level to respond to sounds is achieved. Music therapy is a method that can be used for newborns as it reaches a level that can respond to sound stimuli within weeks. Especially in the 32nd gestational week, preterm newborns begin to develop the ability to distinguish mother's voice from other sounds with regard to rhythm and intonation. Due to this developmental feature of preterm newborns, it is recommended to use the mother's voice in neonatal intensive care units. However, studies on this subject are very limited. The main goal of care in neonatal intensive care units is to maintain the baby's life and comfort at the highest level, to minimize pain and suffering, and to ensure that it can cope with pain. In the light of all information, it is essential to strengthen scientific evidence in order to apply non-pharmacological methods in clinics. The research was planned experimentally in order to examine the effects of listening to a lullaby on pain and physiological parameters in preterms hospitalized in neonatal intensive care units. The participants will be devided in three groups. The first group will listen to the lulliby recorded with the mothers voice, the second group will listen to the the lulliby recorded with the voice of an unfamilliar female, and the third group will not listen to a lulliby. The effects will be measured by using three physiologic parameters (oxygen saturation, heart rate, and respiratory rate) and pain responses (Neonatai Infant Pain Scala) before, during, and after a painful intervention (IV catherization).

Conditions

Neonatal Intensive Care; Music Therapy; Pain Responses

Keywords

premature; pain; lullaby

Outcome Measures

Primary Outcomes (4)

• Change of NIPS (Neonatal Infant Pain Scale) Score

  Pain response according to Neonatal Infant Pain Scale

  15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.

• Change of SpO2 (Oxygen Concentration)

  Oxygen saturation

  15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.

• Change of HR (Heart Rate)

  Heart rate

  15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.

• Change of RR (Respiratory Rate)

  Respiratory rate

  15 minutes before the IV cateherization, 2 minutes before the catherization, during the catherization, 3 minutes after the catherization, and 15 minutes after the catherization.

Study Arms (3)

lullaby mother

EXPERIMENTAL

The participant will listen to a lullaby recorded with his mothers voice.

Other: Listening to a recorded lullaby.

lullaby female

EXPERIMENTAL

The participant will listen to a lullaby recorded with a foreign female voice.

Other: Listening to a recorded lullaby.

no lullaby

NO INTERVENTION

The participant will not listen to a lullaby.

Interventions

Listening to a recorded lullaby. OTHER

A lullaby will be played from the MP4 player on the outer foot of an empty incubator, and a decibel meter (dB) will be placed in the empty incubator, so that the maximum level of the decibel meter does not exceed 50-60 dB (45-65 dB according to APA). ) (American Academy of Pediatrics. ACOG.2007) (Guidelines for Pediatrics Care. 7th edition) sound adjustment will be made. The lullaby with the mother's voice (first arm newborn mothers) adn with an unfamiliar female voice (second arm newborns) will be recorded in MP4 beforehand. The lullabies of groups A and B are lullabies performed in approximately 4 minutes and will be played repeatedly for the specified periods.

lullaby female; lullaby mother

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• At 32-36+6 weeks of gestation
• Stable first 24 hours after birth
• Not dependent on mechanical ventilation
• Non-intubated
• Without a congenital and/or acquired malformation of hearing
• No congenital defect • Without hyperbilirinemia
• Not taking analgesics and/or sedatives in the last 24 hours
• If no painful application has been made to the newborn in the last hour (eg, blood collection, aspiration, eye examination, etc.)
• Postnatal age of 1-7 days
• Preterms whose height and weight are above the 10% percentile according to the week of gestation

You may not qualify if:

• Deterioration in general condition
• Preterms whose parents did not consent to participate in the study

Sponsors & Collaborators

• Izmir Tinaztepe University: lead

Related Publications (12)

• Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.

  PMID: 16580851 BACKGROUND

• de Melo GM, Lelis AL, de Moura AF, Cardoso MV, da Silva VM. [Pain assessment scales in newborns: integrative review]. Rev Paul Pediatr. 2014 Dec;32(4):395-402. doi: 10.1016/j.rpped.2014.04.007.

  PMID: 25511005 BACKGROUND

• Halimaa SL, Vehvilainen-Julkunen K, Heinonen K. Knowledge, assessment and management of pain related to nursing procedures used with premature babies: questionnaire study for caregivers. Int J Nurs Pract. 2001 Dec;7(6):422-30. doi: 10.1046/j.1440-172x.2001.00322.x.

  PMID: 11785445 BACKGROUND

• Yigit S, Ecevit A, Koroglu OA. Turkish Neonatal Society guideline on the neonatal pain and its management. Turk Pediatri Ars. 2018 Dec 25;53(Suppl 1):S161-S171. doi: 10.5152/TurkPediatriArs.2018.01802. eCollection 2018.

  PMID: 31236029 BACKGROUND

• American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.

  PMID: 17079598 BACKGROUND

• Levitin DJ, Tirovolas AK. Current advances in the cognitive neuroscience of music. Ann N Y Acad Sci. 2009 Mar;1156:211-31. doi: 10.1111/j.1749-6632.2009.04417.x.

  PMID: 19338510 BACKGROUND

• Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.

  PMID: 27561729 BACKGROUND

• Dehaene-Lambertz G, Montavont A, Jobert A, Allirol L, Dubois J, Hertz-Pannier L, Dehaene S. Language or music, mother or Mozart? Structural and environmental influences on infants' language networks. Brain Lang. 2010 Aug;114(2):53-65. doi: 10.1016/j.bandl.2009.09.003. Epub 2009 Oct 27.

  PMID: 19864015 BACKGROUND

• Standley JM. A meta-analysis of the efficacy of music therapy for premature infants. J Pediatr Nurs. 2002 Apr;17(2):107-13. doi: 10.1053/jpdn.2002.124128.

  PMID: 12029604 BACKGROUND

• Cevasco AM. The effects of mothers' singing on full-term and preterm infants and maternal emotional responses. J Music Ther. 2008 Fall;45(3):273-306. doi: 10.1093/jmt/45.3.273.

  PMID: 18959452 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

• Vianna MN, Barbosa AP, Carvalhaes AS, Cunha AJ. Music therapy may increase breastfeeding rates among mothers of premature newborns: a randomized controlled trial. J Pediatr (Rio J). 2011 May-Jun 8;87(3):206-12. doi: 10.2223/JPED.2086. Epub 2011 Apr 1. English, Portuguese.

  PMID: 21461451 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pain

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nilüfer Özgürbüz, PhD

  Izmir Tinaztepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NİLÜFER ÖZGÜRBÜZ, PhD

CONTACT

+905064848810; niluferozgurbuz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.Dr. Nilüfer Özgürbüz

Model Details: The participants will be assigned to three groups. Before, during and after a painful intervention the first group (Group A) will listen to a lullaby recorded with the mothers voice, the second group (Group B) will listen to a lullaby recorded with a unfamiliar female voice, and the third group (Group C) without and intervention (no lullaby).

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 24, 2022
• Study Start: March 8, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 30, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share