Clinical trial NCT06474000: Newborn Pain and Stress Levels in Oxytocin Induction at Birth
Official title: The Effect of Using Oxytocin Induction at Birth on Neonatal Pain and Stress.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Vaginal Delivery
Keywords: Oxytocin
Labor
Newborn
Pain
Stress
Induced
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Filling out the ALPS-Neo form before the newborn drying procedure.
timeFrame: In the first minute after birth.
measure: Filling in the ALPS-Neo form during the newborn drying process.
timeFrame: At 5 minutes after birth.
measure: Filling out the ALPS-Neo form after the newborn drying procedure.
timeFrame: At the 5th minute after drying.
Secondary outcomes:
measure: Completion of the ALPS-Neo form before the first injection procedure in the newborn.
timeFrame: At 15 minutes after birth.
measure: Completion of the ALPS-Neo form during the first injection procedure in the newborn.
timeFrame: At 20 minutes after birth.
measure: Completion of the ALPS-Neo form after the first injection procedure in the newborn.
timeFrame: At 5 minutes after the first injection.
Other outcomes:
measure: Filling out the ALPS-Neo form before the newborn blood glucose measurement procedure.
timeFrame: At 30 minutes after birth.
measure: Filling in the ALPS-Neo form during the neonatal blood glucose measurement procedure.
timeFrame: At 35 minutes after birth.
measure: Filling out the ALPS-Neo form after the newborn blood glucose measurement procedure.
timeFrame: At the 5th minute after blood glucose measurement.
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Sena Dilek Aksoy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Darica Farabi Training and Research Hospital
name: Seda Yazici Yel, M.Sc.
role: STUDY_CHAIR
References:
citation: 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.