The Effect of Diaper Change Position on Preterm Infants

Acibadem University

Status: Completed

Conditions: Infant, Premature, Diseases

Treatments: Procedure: Experimental (Legs are flexed toward abdomen) Group; Procedure: Control (Extended leg position) Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04528602

2019-5/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control (Extended leg position) Group

Experimental group

Description:

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.

Treatment:

Procedure: Control (Extended leg position) Group

Experimental (Legs are flexed toward abdomen) Group

Experimental group

Description:

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.

Treatment:

Procedure: Experimental (Legs are flexed toward abdomen) Group