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Newborn Pain and Stress Levels in Oxytocin Induction at Birth

K

Kocaeli University

Status

Completed

Conditions

Induced Vaginal Delivery

Treatments

Behavioral: Control group
Behavioral: Oxytocin induction group

Study type

Interventional

Funder types

Other

Identifiers

NCT06474000
sdilek8

Details and patient eligibility

About

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.

Full 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.

Enrollment

164 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

164 participants in 2 patient groups

Oxytocin induction group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Oxytocin induction group
Control group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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