Kocaeli University
Kocaeli, 41380, Turkey (Türkiye)
NCT Number: NCT06474000
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 G*Power 3.1.9.2 program, taking into account the mean and standard deviation values of the NIPS score in Cetinkaya et al., (2020). Effect size: 0.666, α= 0.05, power: 0.95, 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 29.0 (IBM) program.
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
Not applicable
Kocaeli, 41380, Turkey (Türkiye)
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 29.0 (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 p<0.05.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the oxytocin induction group filled out the "Information Form" at the time of application to the delivery room. Routine care was performed. ALPS-Neo was filled before, during and at 5 minutes after the drying of the newborn within 1-40 minutes after birth. ALPS-Neo was filled before, during and 5 minutes after the first injection. ALPS-Neo was filled before, during and 5 minutes after the blood glucose measurement procedure.
Participants in the control group filled in the "Information Form" when they applied to the birth centre. Routine care was performed. ALPS-Neo was filled before, during and at 5 minutes after the drying of the newborn within 1-40 minutes after birth. ALPS-Neo was filled before, during and 5 minutes after the first injection. ALPS-Neo was filled before, during and 5 minutes after the blood glucose measurement procedure.
Time frame: In the first minute after birth.
ALPS-Neo form was completed before the newborn drying procedure.
Time frame: At 5 minutes after birth.
ALPS-Neo form was filled out during the newborn drying process.
Time frame: At the 5th minute after drying.
ALPS-Neo form was completed after the newborn drying procedure.
Time frame: At 15 minutes after birth.
The ALPS-Neo form was completed before the first injection procedure in the newborn.
Time frame: At 20 minutes after birth.
The ALPS-Neo form was filled out during the first injection procedure of the newborn.
Time frame: At 5 minutes after the first injection.
ALPS-Neo form was filled out after the first injection of the newborn.
Time frame: At 30 minutes after birth.
ALPS-Neo form was filled out before the neonatal blood glucose measurement procedure.
Time frame: At 35 minutes after birth.
ALPS-Neo form was filled out during the neonatal blood glucose measurement procedure.
Time frame: At the 5th minute after blood glucose measurement.
The ALPS-Neo form was filled out after the neonatal blood glucose measurement procedure.
Kocaeli University
Other
The Effect of Using Oxytocin Induction at Birth on Neonatal Pain and Stress.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05404776
Induced Vaginal Delivery
Galveston, Texas, United States
View Trial DetailsNCT06550232
Induced Vaginal Delivery
Nahariya, Israel
View Trial DetailsNCT05981469
Induced Vaginal Delivery
Liverpool, United Kingdom
View Trial DetailsNCT06560515
Induced Vaginal Delivery
Alexandria, Egypt
View Trial Details