Clinical trial NCT04528602: The Effect of Diaper Change Position on Preterm Infants
Official title: The Effect of Diaper Change Position on Neonatal Comfort and Heart Rate, Respiratory Rate and Oxygen Saturation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Keywords: preterm
diaper change
comfort
position
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the effect of diaper change position on neonatal comfort and heart rate, respiratory rate and oxygen saturation in preterm infants.

Detailed description: This study was planned as a randomized controlled prospective trial until reaching the entire sample group specified in the Neonatal Intensive Care Units (NICU) in a private hospital that has other branches in Istanbul.

During the data collection process, two methods will be applied to preterm infants during diaper change.

In the control group of the study, diaper change will be performed after the legs of the babies are brought to extension, and in the experimental group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen by maintaining their flexion. Data on the babies' heart rate, respiratory rate, oxygen saturation and comfort level will be collected using the Premature Infant Comfort Scale before, during, immediately after and 3 minutes after the procedure.

The researchers will collect the data by using a form that questions individual characteristics and includes records of heart rate, respiratory rate and oxygen saturation and Premature Infant Comfort.

Eligibility criteria: Inclusion Criteria:

* The preterm infants whose
* Parents have agreed to participate in the study and have signed the informed consent form,
* Who have no congenital anomalies,
* Have no chronic illnesses,
* Have undergone Underwent no surgical procedures,
* Have no neurological symptoms,
* Have not been diagnosed with sepsis,
* Have not been sedated,
* Have not received any pharmacological analgesic method four hours before,
* Have been born between ≥28 and ≤36+6 gestational weeks or have been born earlier and are between ≥28 and ≤36+6 gestational weeks during the application, will be included.

Exclusion Criteria:

The preterm infants whose

* Parents have not agreed to participate in the study and have not signed the informed consent form,
* Who have congenital anomalies,
* Have chronic illnesses,
* Have undergone surgical procedures,
* Have neurological symptoms,
* Have been diagnosed with sepsis,
* Have been sedated,
* Have received pharmacological analgesic methods four hours before,
* Were between \<28 and \>36+6 gestational weeks, will be excluded.

Primary outcomes:
measure: Change in Heart rate
timeFrame: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
measure: Change in Respiratory Rate
timeFrame: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
measure: Change in Oxygen Saturation
timeFrame: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
measure: Change in Comfort
timeFrame: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University
state: Atasehir
Study officials:
affiliation: Acibadem University
name: Zehra Kan Öntürk
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyngstad LT, Tandberg BS, Storm H, Ekeberg BL, Moen A. Does skin-to-skin contact reduce stress during diaper change in preterm infants? Early Hum Dev. 2014 Apr;90(4):169-72. doi: 10.1016/j.earlhumdev.2014.01.011. Epub 2014 Feb 16.
citation: Morelius E, Hellstrom-Westas L, Carlen C, Norman E, Nelson N. Is a nappy change stressful to neonates? Early Hum Dev. 2006 Oct;82(10):669-76. doi: 10.1016/j.earlhumdev.2005.12.013. Epub 2006 Feb 28.
citation: Kolcaba KY. Holistic comfort: operationalizing the construct as a nurse-sensitive outcome. ANS Adv Nurs Sci. 1992 Sep;15(1):1-10. doi: 10.1097/00012272-199209000-00003.
citation: Grunau RE, Weinberg J, Whitfield MF. Neonatal procedural pain and preterm infant cortisol response to novelty at 8 months. Pediatrics. 2004 Jul;114(1):e77-84. doi: 10.1542/peds.114.1.e77.
citation: Picheansathian W, Woragidpoonpol P, Baosoung C. Positioning of Preterm Infants for Optimal Physiological Development: a systematic review. JBI Libr Syst Rev. 2009;7(7):224-259. doi: 10.11124/01938924-200907070-00001.