Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04528602
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2020-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Diaper Change Position on Preterm Infants
Sponsor:
Acibadem University
Organization:
Study Overview
Official Title:
The Effect of Diaper Change Position on Neonatal Comfort and Heart Rate, Respiratory Rate and Oxygen Saturation in Preterm Infants
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: