Newborn Pain and Stress Levels in Oxytocin Induction at Birth

Not Applicable

Completed

• Conditions: Induced Vaginal Delivery

• Registration Number: NCT06474000
• Lead Sponsor: Kocaeli University

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 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.

Study Timeline

• Study Start: 2023-01-20
• Primary Completion: 2023-12-10
• Study Completion: 2023-12-10
• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

Inclusion Criteria

• Pregnant at term,
• Giving birth vaginally,
• Birth weight ≥2500gr,
• Participants with a single and healthy fetus and their newborns

Exclusion Criteria

• Mentally incompetent,
• Having a high-risk pregnancy,
• Those with risky newborns

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Filling in the ALPS-Neo form during the newborn drying process.	At 5 minutes after birth.	ALPS-Neo form was filled out during the newborn drying process.
Filling out the ALPS-Neo form after the newborn drying procedure.	At the 5th minute after drying.	ALPS-Neo form was completed after the newborn drying procedure.
Filling out the ALPS-Neo form before the newborn drying procedure.	In the first minute after birth.	ALPS-Neo form was completed before the newborn drying procedure.

Secondary Outcome Measures

Name	Time	Method
Completion of the ALPS-Neo form during the first injection procedure in the newborn.	At 20 minutes after birth.	The ALPS-Neo form was filled out during the first injection procedure of the newborn.
Completion of the ALPS-Neo form after the first injection procedure in the newborn.	At 5 minutes after the first injection.	ALPS-Neo form was filled out after the first injection of the newborn.
Completion of the ALPS-Neo form before the first injection procedure in the newborn.	At 15 minutes after birth.	The ALPS-Neo form was completed before the first injection procedure in the newborn.

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey