Newborn Pain and Stress Levels in Oxytocin Induction at Birth
NCT Number: NCT06474000
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Induced Vaginal Delivery
Interventions: BEHAVIORAL: Oxytocin induction group|BEHAVIORAL: Control group
Sponsor: Kocaeli University
Sex: FEMALE
Age: ADULT
Enrollment: 164
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2023-01-20
Completion Date: 2023-12-10
Locations: Kocaeli University, Kocaeli, 41380, Turkey

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.

Primary Outcome Measures: 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: 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: 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.