NCT06474000

Newborn Pain and Stress Levels in Oxytocin Induction at Birth

The Effect of Using Oxytocin Induction at Birth on Neonatal Pain and Stress.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Kocaeli University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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 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.

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 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.

Conditions

• Induced Vaginal Delivery

Interventions

Type	Name	Description
BEHAVIORAL	Oxytocin induction group	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.
BEHAVIORAL	Control group	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.

Timeline

• Start date: 2023-01-20
• Primary completion: 2023-12-10
• Completion: 2023-12-10
• First posted: 2024-06-25
• Last updated: 2024-06-25

Locations

1 site across 1 country: Turkey (Türkiye)