Newborn Pain and Stress Levels in Oxytocin Induction at Birth

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

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.

Study Overview

• Status: Completed
• Conditions: Induced Vaginal Delivery
• Intervention / Treatment: Behavioral: Oxytocin induction group; Behavioral: Control group

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 Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41380
    • Kocaeli University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxytocin induction group; Participants in the oxytocin induction group received oxytocin induction during labour. The ALPS-Neo form was completed between 1-40 minutes after delivery, based on observation before, during and after the drying process, the first injection process and the blood glucose measurement procedures.	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.
Active Comparator: Control group; Participants in the control group did not receive oxytocin induction during labour. The ALPS-Neo form was completed between 1-40 minutes after delivery, based on observation before, during and after the drying process, the first injection procedure and the blood glucose measurement procedures.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Filling out the ALPS-Neo form before the newborn blood glucose measurement procedure.	ALPS-Neo form was filled out before the neonatal blood glucose measurement procedure.	At 30 minutes after birth.
Filling in the ALPS-Neo form during the neonatal blood glucose measurement procedure.	ALPS-Neo form was filled out during the neonatal blood glucose measurement procedure.	At 35 minutes after birth.
Filling out the ALPS-Neo form after the newborn blood glucose measurement procedure.	The ALPS-Neo form was filled out after the neonatal blood glucose measurement procedure.	At the 5th minute after blood glucose measurement.

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Sena Dilek Aksoy, Ph.D., Kocaeli University; Study Chair: Seda Yazici Yel, M.Sc., Darica Farabi Training and Research Hospital

Publications and helpful links

General Publications

• Cetinkaya S, Yavas Celik M, Ozdemir S. Effect of white noise on alleviating the pain of new-born during invasive procedures. J Matern Fetal Neonatal Med. 2022 Apr;35(8):1426-1432. doi: 10.1080/14767058.2020.1755652. Epub 2020 Apr 21.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Actual): December 10, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Stress; Oxytocin; Newborn; Labor; Induced
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: sdilek8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No