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NewbornNCT05064683

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

A study testing white noise in people with Newborn and Newborn Sleep, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 days to 1 monthHealthy volunteers can take part
Conditions the study is for
Newborn, Newborn Sleep, Newborn Stress
What is being tested?
white noise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2021to 4 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 days to 1 month
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • Congenital anomaly of the newborn
  • Newborns with hearing loss

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Inonu University

    Malatya, 44280

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Sleep is very important for human life and includes both physiological and mental processes in development. Sleep is considered not only as a resting state, but also as a state of intense brain development in which neurotransmitters specific to each sleep stage affect brain maturation. Sleep constitutes a large part of the life of newborns and children. However, total daily sleep time, time to fall asleep, daytime sleep and sleep structure may differ according to the age of the child. It is known that the brain activity of newborns in the intrauterine period is completely similar to the sleep activity of the REM period, 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. Newborns who are separated from the warm, dark, quiet, calm, fluid-filled mother's womb, which is the natural environment for them after birth, undergo biochemical and physiological changes involving all their systems in the first days of their life, and may experience difficulties in adapting to extrauterine life due to various reasons. Respiratory problems are among the leading causes of mortality and morbidity in the neonatal period. Nasal CPAP and mechanical ventilation support are the leading techniques used to provide oxygenation and ventilation in the treatment of infants with or without respiratory distress. Nasal CPAP is widely used in newborns, especially preterm infants, both as primary therapy and as a respiratory support method after extubation. However, complications such as hyperemia in the nose, crust formation, bleeding, forehead and face injuries, and infection may develop due to CPAP application. In order to prevent possible complications, neonatal intensive care unit (NICU) nurses should be trained about these risks and complications, specialist nursing care and infection. control protocols should be implemented.Nurses who spend the most time in the neonatal intensive care unit are members of the profession responsible for ensuring the adaptation of newborns to the external environment, optimal growth and development, protection from diseases and maximizing the condition of the newborn, as well as basic nursing practices. The neonatal intensive care nurse monitors the clinical signs and symptoms of the newborn, evaluates and interprets in line with evidence-based information, and determines the care needs with a family-centered approach, makes the nursing diagnosis, plans and implements the care, provides training and counseling . When determining the care needs, it takes into account the risk status of the newborn, the length of hospitalization, the stimuli to which he is exposed, the level of pain and stress, the application of surgical intervention and the presence of invasive applications . In order to prevent situations that reduce or consume the energy resources required for physiological growth of the newborn, to protect the energy resources that are wasted, to accelerate the healing process, to reduce pain, stress, autonomic response and oxygen consumption, to provide sleep pattern, comfort and immobilization, the neonatal intensive care nurse has and non-pharmacological methods. Facilitated tucking white noise are among the non-pharmacological methods frequently used by neonatal nurses.The facilitated tucking is a method that allows the baby to feel and calm down in the womb, to develop behaviors to cope with pain and stress, to feel safe, and to provide body control. In addition, it is a position that improves the sleep pattern that supports motor development, growth and development, and creates a synergistic effect in pain control. It has been reported that this position provides heat and tactile stimulation in newborns, activating the newborns' regulatory systems, preventing painful stimuli from the external environment and reducing the pain experienced by the newborns. Studies have also shown that the facilitated tucking warmth and tactile stimulation in newborns, activates the newborn's own regulatory systems, activates the newborn's attention, prevents painful stimuli originating from the external environment, increases the release of endogenous endorphins, helps the distribution of pain impulses in the spinal cord, and reduces the pain felt by newborn . It has been stated that it is an effective method in reducing the crying time and pain after the procedures.

White noise is a continuous monotonous sound such as the sound of wind, waterfall, ocean waves or rain coming from the environment, and it is a sound that is prepared digitally by mixing different frequency sounds in equal proportions in the laboratory environment and is prepared by calibrating all the frequencies in the sound and it is pleasant to the ear. White noise sources include rain, waterfall, water sounds, hair dryer sound, vacuum cleaner sound, aspirator sound, clock sound, heart sound. When the literature is examined that white noise played during the heel blood collection process in newborns reduces the baby's pain score and shortens the crying time. Similarly, preterm newborns were listened to during the white noise vaccination process and it was found to have a pain-reducing effect compared to the control group.

White noise is similar to the sound in the womb as it is a humming and continuous monotonous sound. It is known that the newborn is affected by the mother's heartbeat while in the womb, and finding this sound and rhythm after birth has a relaxing effect on the newborn. In experimental studies conducted in the relevant field, it has been observed that newborns sleeping in a room where the sound of the uterus is heard fall asleep earlier than those in the room where no sound is heard, and this shows that newborns begin to gain a certain sensitivity to music before they are born.

When the literature is examined, it has been stated facilitated tucking white noise may affect the sleep quality of newborns. However, it has been observed that there is no study examining the difference between facilitated tucking and white noise. In this direction, research was carried out to examine the effects of facilitated tucking and white noise on the stress and sleep of newborns in Nasal CPAP.

Being tested
white noise
Keywords
newborn, sleep, stress, white noise, facilitated tucking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • white noiseOther

    Also called facilitated tucking, control

    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.

Study groups in NCT05064683
Study groupRoleWhat they receive
white noiseExperimentalThe 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.
Receives: Other: white noise
facilitated tuckingExperimentalThe newborns in the facilitated tucking were given supine, prone, and lateral positions for 24 hours, depending on their clinical status.
Receives: Other: white noise
controlNo interventionNewborns in the control group did not receive any treatment other than routine applications while receiving Nasal CPAP support in the neonatal intensive care unit.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hours

Secondary outcomes (1)
  1. Changes in stress

    Nurses followed their stress levels with the newborn stress scale for 24 hours and recorded them on the newborn follow-up form.Minimum 0 points, 28 maximum 16 points are taken from the scale. As the score increases, the newborns stress level increases.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2021
  2. Study start1 Sep 2021
  3. Primary completion4 Feb 2022
  4. Study completion4 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05064683
Sponsor's protocol ID
Yenidoğanlarda uyku
Status last verified
Mar 2022
First submitted
22 Sep 2021
Last updated
15 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Çalışır H, Güler F. Yenidoğan Yoğun Bakım Ünitesinde Mekanik Ventilasyon Uygulanan Prematüre Bebeklere Pozisyon Verme.Türkiye Klinikleri J Nurs Sci. 2017;9(3):227-23.2 .

  • Huang YS, Paiva T, Hsu JF, Kuo MC, Guilleminault C. Sleep and breathing in premature infants at 6 months post-natal age. BMC Pediatr. 2014 Dec 16;14:303. doi: 10.1186/s12887-014-0303-6.

    PubMed 25510740
  • Kurt FY, Aytekin A, Çelebi A. 0-3 Yaş Çocuklarda Uyku Sorunlarının Belirlenmesi. Zeynep Kamil Tıp Bülteni. 2018;49(3), 259-263.

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

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

  • 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.

  • 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.

    PubMed 30400844
  • 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.

    PubMed 32680615
  • Tiryaki Ö, Çınar N . Devamlı Pozitif Hava Yolu Basıncındaki Yenidoğanın Hemşirelik Bakımı. Turkiye Klinikleri Journal of Nursing Sciences. 2016; 8(1):79-85.

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

  • 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.

    PubMed 15123970
  • 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.

    PubMed 16357666
  • 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.

    PubMed 16410042
  • 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.

    PubMed 19915422
  • 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.

    PubMed 15136961

Questions about this trial

What is this clinical trial studying?

A study testing white noise in people with Newborn and Newborn Sleep, run by Inonu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in sleep (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05064683, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.

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