CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Control (Extended leg position) Group +1 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04528602
NCT04528602N/ACompleted

The Effect of Diaper Change Position on Neonatal Comfort and Heart Rate, Respiratory Rate and Oxygen Saturation in Preterm Infants

Acibadem University·interventional·Posted Aug 27, 2020·Updated Aug 25, 2021

In Brief

A clinical study evaluating Control (Extended leg position) Group and Experimental (Legs are flexed toward abdomen) Group for Infant, Premature, Diseases. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 27, 2020
Enrollment StartMay 17, 2019
Primary CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.8 years ago

Interventions

Control (Extended leg position) Groupprocedure

Common procedure steps -Legal representatives of the infants will sign an informed consent form. Materials (soap, napkin, non-sterile gloves, diaper, wet cotton towels for newborns, waste container, diaper change mat) will be prepared. Hands will be washed and gloves will be worn. Tapes of the infant's dirty diaper will be opened. For the Control Group -The infant will be grasped on the legs, the legs will be given extension position and lifted up. The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back. The infant's feet will be freed. The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed. The infant's legs will be given in extension position and a clean diaper will be placed under them. Tapes of the clean diaper will be fastened. Hands will be washed after the procedure Data will be collected before, during, after and 3 minutes after application.

Experimental (Legs are flexed toward abdomen) Groupprocedure

Procedure steps for the Experimental Group * Common procedure steps * The infant will be grasped on the legs; the legs will be kept in the flexion position and approached toward the abdomen. * The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back. * The infant's feet will be freed. * The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed and thrown into the medical waste bin. * The infant's legs will be kept in the flexion position and a clean diaper will be placed under them. A bottom care plan will be applied in line with the treatment plan, if necessary. * Tapes of the clean diaper will be fastened. * Hands will be washed after the procedure. * Data will be collected immediately before, during, immediately after and 3 minutes after the end of application.