The Effect of Facilitated Tucking and White Noise on Stress and Sleep of Newborns in Nasal CPAP

NCT05064683 | Completed

• 1 other identifier: Yenidoğanlarda uyku
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Newborns go through biochemical and physiological changes involving all their systems in the first days of their lives and may experience difficulties in adapting to extrauterine life due to various reasons. For newborns whose systems are still immature, leaving the warm, dark, quiet, calm, fluid-filled mother's womb and placing them in the intensive care unit with many stimuli creates intense stress and negatively affects the sleep-wake order necessary for brain development and maturation. Newborns have extensive sleep requirements for the development of their neurosensory system. It is known that the brain activity of newborns in the intrauterine period is similar to the REM (Rapid Eye Movement) sleep activity, and they sleep more than adults and spend most of their sleep in the REM sleep period.Therefore, sleep quality in the newborn period is directly related to healthy development.In this direction, our research was carried out to examine the effects of fetal position and white noise on stress and sleep in newborns with nasal CPAP(Continuous Positive Airway Pressure). Design and Methods: . This randomized experimental study was conducted on 108 newborns at the gestational week of 26 or higher in the newborn intensive care unit of a university hospital. The researcher applied white noise (n:36), and facilitated tucking(n:36) to the newborns. The control group (n: 36) received no intervention except for the routine clinical practices. Facilitated tucking white noise interventions were applied to the newborns included in study for 24 hours, their stress levels were monitored with the neonatal stress scale, and their sleep durations were monitored with a sleep-wakefulness measurement device and recorded in the newborn follow-up form. Statistical analysis was performed using percentages, means, and ANOVA test.

Conditions

Newborn; Newborn Sleep; Newborn Stress

Keywords

newborn; sleep; stress; white noise; facilitated tucking

Outcome Measures

Primary Outcomes (1)

• Changes in sleep

  Nurses followed the sleep duration of newborns with a sleep-wake measurement device for 24 hours and recorded in the Newborn Follow-up Form.

  24 hours

Secondary Outcomes (1)

• Changes in stress

  24 hours

Study Arms (3)

white noise

EXPERIMENTAL

The newborns in the white noise group were listened to white noise for 24 hours using an Mp3 player and a decibel measuring device to measure the sound level.

Other: white noise

facilitated tucking

EXPERIMENTAL

The newborns in the facilitated tucking were given supine, prone, and lateral positions for 24 hours, depending on their clinical status.

Other: white noise

control

NO INTERVENTION

Newborns in the control group did not receive any treatment other than routine applications while receiving Nasal CPAP support in the neonatal intensive care unit.

Interventions

white noise OTHER

Newborns in the control group did not receive any treatment other than routine applications while receiving nasal CPAP support in the neonatal intensive care unit.The newborns in the faciliated tucking group were given supine, prone, and lateral positions for 24 hours, depending on their clinical status.The newborns in the white noise group were listened to white noise for 24 hours using an Mp3 player and a decibel measuring device to measure the sound level.

Also known as: facilitated tucking, control

facilitated tucking; white noise

Eligibility Criteria

• Age: 0 Days - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients at 26 and above gestational weeks receiving nasal CPAP support.
• Newborns who do not have a health problem that prevents them from being positioned
• Newborns regularly visited by their mothers in neonatal intensive care clinics

You may not qualify if:

• Congenital anomaly of the newborn
• Newborns with hearing loss

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (19)

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  BACKGROUND

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  BACKGROUND

• Küçük S. Yenidoğan yoğun bakım ünitelerinde kaliteli uyku.Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi. 2015; 8(3): 214-217.

  BACKGROUND

• Arpaci T, Altay N. Yenidoğan Yoğun Bakım Ünitelerinde Bireyselleştirilmiş Gelişimsel Bakım: Güncel Yaklaşımlar. Turkiye Klinikleri Hemşirelik Bilimleri. 2017;9(3): 245-54

  BACKGROUND

• Başkan AK, Salihoğlu Ö, Tan İ, Akyol B, Hatipoğlu S. İnvaziv Mekanik Ventilatör Desteği Alan Yenidoğanlarda Morbidite ve Mortalite Analizi. Journal of Clinical and Experimental Investigations. 2012; 3 (4): 483-492.

  BACKGROUND

• Dewez JE, Chellani H, Nangia S, Metsis K, Smith H, Mathai M, van den Broek N. Healthcare workers' views on the use of continuous positive airway pressure (CPAP) in neonates: a qualitative study in Andhra Pradesh, India. BMC Pediatr. 2018 Nov 6;18(1):347. doi: 10.1186/s12887-018-1311-8.

  PMID: 30400844 BACKGROUND

• Cakici M, Mutlu B. Effect of Body Position on Cardiorespiratory Stabilization and Comfort in Preterm Infants on Continuous Positive Airway Pressure. J Pediatr Nurs. 2020 Sep-Oct;54:e1-e8. doi: 10.1016/j.pedn.2020.06.015. Epub 2020 Jul 15.

  PMID: 32680615 BACKGROUND

• Tiryaki Ö, Çınar N . Devamlı Pozitif Hava Yolu Basıncındaki Yenidoğanın Hemşirelik Bakımı. Turkiye Klinikleri Journal of Nursing Sciences. 2016; 8(1):79-85.

  BACKGROUND

• Houck CS. Neonatal Pain Management. Pediatric Pain Management for Primary Care, America. 2005, s.361.

  BACKGROUND

• Ward-Larson C, Horn RA, Gosnell F. The efficacy of facilitated tucking for relieving procedural pain of endotracheal suctioning in very low birthweight infants. MCN Am J Matern Child Nurs. 2004 May-Jun;29(3):151-6; quiz 157-8. doi: 10.1097/00005721-200405000-00004.

  PMID: 15123970 BACKGROUND

• Hill S, Engle S, Jorgensen J, Kralik A, Whitman K. Effects of facilitated tucking during routine care of infants born preterm. Pediatr Phys Ther. 2005 Summer;17(2):158-63. doi: 10.1097/01.pep.0000163097.38957.ec.

  PMID: 16357666 BACKGROUND

• Axelin A, Salantera S, Lehtonen L. 'Facilitated tucking by parents' in pain management of preterm infants-a randomized crossover trial. Early Hum Dev. 2006 Apr;82(4):241-7. doi: 10.1016/j.earlhumdev.2005.09.012. Epub 2006 Jan 10.

  PMID: 16410042 BACKGROUND

• Obeidat H, Kahalaf I, Callister LC, Froelicher ES. Use of facilitated tucking for nonpharmacological pain management in preterm infants: a systematic review. J Perinat Neonatal Nurs. 2009 Oct-Dec;23(4):372-7. doi: 10.1097/JPN.0b013e3181bdcf77.

  PMID: 19915422 BACKGROUND

• Huang CM, Tung WS, Kuo LL, Ying-Ju C. Comparison of pain responses of premature infants to the heelstick between containment and swaddling. J Nurs Res. 2004 Mar;12(1):31-40. doi: 10.1097/01.jnr.0000387486.78685.c5.

  PMID: 15136961 BACKGROUND

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  PMID: 20971562 BACKGROUND

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  PMID: 24534413 BACKGROUND

• Kucukoglu S, Aytekin A, Celebioglu A, Celebi A, Caner I, Maden R. Effect of White Noise in Relieving Vaccination Pain in Premature Infants. Pain Manag Nurs. 2016 Dec;17(6):392-400. doi: 10.1016/j.pmn.2016.08.006. Epub 2016 Oct 15.

  PMID: 27751753 BACKGROUND

• Standley JM. Music therapy for the neonate. Newborn and Infant Nursing Reviews. 2001;1:211-216.

  BACKGROUND

MeSH Terms

Interventions

Facilitated Tucking

Intervention Hierarchy (Ancestors)

Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher assistant

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: September 1, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

TU (1)