Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474000
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Newborn Pain and Stress Levels in Oxytocin Induction at Birth
Sponsor:
Kocaeli University
Organization:
Kocaeli University
Study Overview
Official Title:
The Effect of Using Oxytocin Induction at Birth on Neonatal Pain and Stress
Status:
COMPLETED
Status Verified Date:
2024-06
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 aim of the study is to compare pain and stress levels in the early neonatal period in newborns with and without oxytocin induction The research was conducted in a case-control study design The population of the study consisted of participants who gave birth vaginally with or without oxytocin induction The sample number of the study was calculated with the GPower 3192 program taking into account the mean and standard deviation values of the NIPS score in Cetinkaya et al 2020 Effect size 0666 α 005 power 095 oxytocin induction group 60 non-oxytocin induction group 60 Anticipating possible data loss 164 participants and their newborns were included 85 in the oxytocin induction group and 79 in the non-oxytocin induction group was included The data of the study were collected using the Pregnant Information Form Neonatal Follow-up Form and Newborn Pain and Stress Assessment Scale ALPS-Neo The research data were analyzed in SPSS 290 IBM program
Detailed Description:
Purpose To compare the pain and stress levels of painful stimuli in the early neonatal period in newborns with and without oxytocin induction
H1 There is a statistical difference between the ALPS-Neo scores of the newborns of the group in which oxytocin induction was applied in labor and the group in which it was not applied
H0 There is no statistical difference between the ALPS-Neo scores of the newborns of the group that underwent oxytocin induction in labor and the group that did not
The data of the study were collected using the Pregnant Information Form Neonatal Follow-up Form and Newborn Pain and Stress Assessment Scale ALPS-Neo
In the study participants were divided into two groups those with and without oxytocin induction and the data were collected based on self-report Newborn painful stimuli were discussed under 3 headings drying process first injection process and blood sugar measurement process Before during and after these procedures data were confirmed and collected by one researcher and the other by an independent observer
Statistical analysis was performed using IBM SPSS Statistic 290 IBM Corp Armonk NY USA Descriptive statistical methods number percentage mean standard deviation were used to evaluate socio-demographic data It was used in comparative analysis of the data chi square t test etc P value was considered significant at p005
H1 There is a statistical difference between the ALPS-Neo scores of the newborns of the group in which oxytocin induction was applied in labor and the group in which it was not applied
H0 There is no statistical difference between the ALPS-Neo scores of the newborns of the group that underwent oxytocin induction in labor and the group that did not
The data of the study were collected using the Pregnant Information Form Neonatal Follow-up Form and Newborn Pain and Stress Assessment Scale ALPS-Neo
In the study participants were divided into two groups those with and without oxytocin induction and the data were collected based on self-report Newborn painful stimuli were discussed under 3 headings drying process first injection process and blood sugar measurement process Before during and after these procedures data were confirmed and collected by one researcher and the other by an independent observer
Statistical analysis was performed using IBM SPSS Statistic 290 IBM Corp Armonk NY USA Descriptive statistical methods number percentage mean standard deviation were used to evaluate socio-demographic data It was used in comparative analysis of the data chi square t test etc P value was considered significant at p005
Study Oversight
Has Oversight DMC:
None
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?:
None