Clinical Trials Directory

Trials / Completed

CompletedNCT04528602

The Effect of Diaper Change Position on Preterm Infants

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Acibadem University · Academic / Other
Sex
All
Age
1 Day – 28 Days
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREControl (Extended leg position) GroupCommon 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.
PROCEDUREExperimental (Legs are flexed toward abdomen) GroupProcedure 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.

Timeline

Start date
2019-05-17
Primary completion
2020-05-01
Completion
2020-05-01
First posted
2020-08-27
Last updated
2021-08-25

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04528602. Inclusion in this directory is not an endorsement.