Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05064683
Other study ID # Yenidoganlarda uyku
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date February 4, 2022

Study information

Verified date March 2022
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date February 4, 2022
Est. primary completion date February 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 1 Month
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Congenital anomaly of the newborn - Newborns with hearing loss

Study Design


Related Conditions & MeSH terms


Intervention

Other:
white noise
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.

Locations

Country Name City State
Turkey Inonu University Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (19)

Arpaci T, Altay N. Yenidogan Yogun Bakim Ünitelerinde Bireysellestirilmis Gelisimsel Bakim: Güncel Yaklasimlar. Turkiye Klinikleri Hemsirelik Bilimleri. 2017;9(3): 245-54

Axelin A, Salanterä 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. Epub 2006 Jan 10. — View Citation

Baskan AK, Salihoglu Ö, Tan I, Akyol B, Hatipoglu S. Invaziv Mekanik Ventilatör Destegi Alan Yenidoganlarda Morbidite ve Mortalite Analizi. Journal of Clinical and Experimental Investigations. 2012; 3 (4): 483-492.

Çakici 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. — View Citation

Çalisir H, Güler F. Yenidogan Yogun Bakim Ünitesinde Mekanik Ventilasyon Uygulanan Prematüre Bebeklere Pozisyon Verme.Türkiye Klinikleri J Nurs Sci. 2017;9(3):227-23.2 .

Chorna OD, Slaughter JC, Wang L, Stark AR, Maitre NL. A pacifier-activated music player with mother's voice improves oral feeding in preterm infants. Pediatrics. 2014 Mar;133(3):462-8. doi: 10.1542/peds.2013-2547. Epub 2014 Feb 17. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Johnston CC, Fernandes AM, Campbell-Yeo M. Pain in neonates is different. Pain. 2011 Mar;152(3 Suppl):S65-S73. doi: 10.1016/j.pain.2010.10.008. Epub 2010 Oct 23. Review. — View Citation

Küçük S. Yenidogan yogun bakim ünitelerinde kaliteli uyku.Dokuz Eylül Üniversitesi Hemsirelik Fakültesi Elektronik Dergisi. 2015; 8(3): 214-217.

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. — View Citation

Kurt FY, Aytekin A, Çelebi A. 0-3 Yas Çocuklarda Uyku Sorunlarinin Belirlenmesi. Zeynep Kamil Tip Bülteni. 2018;49(3), 259-263.

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. Review. — View Citation

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

Tiryaki Ö, Çinar N . Devamli Pozitif Hava Yolu Basincindaki Yenidoganin Hemsirelik Bakimi. Turkiye Klinikleri Journal of Nursing Sciences. 2016; 8(1):79-85.

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. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 24 hours
See also
  Status Clinical Trial Phase
Recruiting NCT06350084 - Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection N/A
Not yet recruiting NCT04441463 - Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth (TryPla) N/A
Not yet recruiting NCT04337229 - Evaluation of Comfort Behavior Levels of Newborns With Artificial Intelligence Techniques N/A
Completed NCT01732978 - Are Parents Privileged Listeners Their Baby ? N/A
Unknown status NCT01029496 - Immediate VS Delayed Cord Clamping on Newborns Phase 1/Phase 2
Recruiting NCT06032494 - Investigating Changes in Vital Signs in Neonates
Completed NCT03690804 - Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units N/A
Completed NCT04827849 - Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby N/A
Not yet recruiting NCT03630575 - Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study N/A
Recruiting NCT03109444 - Normative Radiographic Parameters and Growth Curve of Hips Less Than Six Weeks of Gestational Age Using Ultrasound
Not yet recruiting NCT06053931 - The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort N/A
Completed NCT04869176 - Effect of Caffeine on Heart Rate Variability in Newborns N/A
Completed NCT05103800 - Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive Interventions in Newborns N/A
Not yet recruiting NCT05109481 - Masks and Visual Preferences in the Newborn
Completed NCT03047967 - Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns N/A
Not yet recruiting NCT06418815 - Concept Map on Toxic Stress in Newborns N/A
Completed NCT03969459 - Impact of Exposure to Persistent Organic Pollutants During Pregnancy on the Composition of Breast Milk and Consequences on the Newborn
Completed NCT06352918 - Peripheral Central Catheter (PICC) Care N/A
Completed NCT05442619 - Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation During Venous Blood Collection N/A
Not yet recruiting NCT03112798 - Miller vs Macintosh Size 0 Blades for Tracheal Intubation of Infants N/A