The Effect of Using Oxytocin Induction at Birth on Neonatal Pain and Stress.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kocaeli University
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Filling in the ALPS-Neo form during the newborn drying process.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
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.
Intervention: Oxytocin induction group (Behavioral)
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.
Intervention: Control group (Behavioral)
Outcomes
Primary Outcomes
Filling in the ALPS-Neo form during the newborn drying process.
Time Frame: 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.
Time Frame: 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.
Time Frame: In the first minute after birth.
ALPS-Neo form was completed before the newborn drying procedure.
Secondary Outcomes
- Completion of the ALPS-Neo form during the first injection procedure in the newborn.(At 20 minutes after birth.)
- Completion of the ALPS-Neo form after the first injection procedure in the newborn.(At 5 minutes after the first injection.)
- Completion of the ALPS-Neo form before the first injection procedure in the newborn.(At 15 minutes after birth.)
Investigators
sena dilek
Principal Investigator
Kocaeli University