The Effect of Diaper Change Position on Preterm Infants

Not Applicable

Completed

• Conditions: Infant, Premature, Diseases
• Interventions: Procedure: Control (Extended leg position) Group; Procedure: Experimental (Legs are flexed toward abdomen) Group

• Registration Number: NCT04528602
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study Start: 2019-05-17
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (Extended leg position) Group	Control (Extended leg position) Group	In the control (Extended leg position) group of the study, diaper change will be performed after the legs of the babies are brought to extension.
Experimental (Legs are flexed toward abdomen) Group	Experimental (Legs are flexed toward abdomen) Group	In the experimental (Legs are flexed toward abdomen) group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen while maintaining their flexion leg position.

Primary Outcome Measures

Name	Time	Method
Change in Oxygen Saturation	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.	Preterm infant will be monitored and respiratory rate will be monitored.
Change in Heart rate	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.	Preterm infant will be monitored and heart rate will be monitored.
Change in Respiratory Rate	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.	Preterm infant will be monitored and respiratory rate will be monitored.
Change in Comfort	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.	Premature Infant Comfort Scale (PICS), which is a multidimensional scale used in evaluating comfort and pain behaviorally and psychologically. The PICS evaluates seven parameters as Alertness, Calmness/Agitation, Respiratory Status (only on mechanic ventilation support) or Crying (not evaluated because it is scored in children with spontaneous breathing), Physical Movements, Muscle Tone, Facial Gestures and Mean Heart Rate. It is a five-point likert scale in which each element is scored from one to five (from bad to good). According to the PICS, the infant's comfort is evaluated over the total score. Accordingly, 35 points signify the lowest comfort score, while seven points signify the highest comfort score. High score obtained from the scale signifies that the comfort level is low. If the total score is ≥17, this is the cut-off value of the scale. It was found that the Turkish version was a valid and reliable.

Trial Locations

Locations (1)

Acıbadem University; 🇹🇷 Istanbul, Atasehir, Turkey