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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06474000
Enrollment
164
Registered
2024-06-25
Start date
2023-01-20
Completion date
2023-12-10
Last updated
2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induced Vaginal Delivery

Keywords

Oxytocin, Labor, Newborn, Pain, Stress, Induced

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.

Interventions

BEHAVIORALOxytocin 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.

BEHAVIORALControl 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.

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.
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.

Secondary

MeasureTime frameDescription
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 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.
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.

Other

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026