Newborn Pain and Stress Levels in Oxytocin Induction at Birth

NCT06474000 | Completed

• 1 other identifier: sdilek8
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Induced Vaginal Delivery

Keywords

Oxytocin; Labor; Newborn; Pain; Stress; Induced

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Completion of the ALPS-Neo form 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.

  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.

Other Outcomes (3)

• Filling out the ALPS-Neo form before the newborn blood glucose measurement procedure.

  At 30 minutes after birth.

• Filling in the ALPS-Neo form 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.

  At the 5th minute after blood glucose measurement.

Study Arms (2)

Oxytocin induction group

ACTIVE COMPARATOR

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.

Behavioral: Oxytocin induction group

Control group

ACTIVE COMPARATOR

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.

Behavioral: Control group

Interventions

Oxytocin induction group BEHAVIORAL

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.

Oxytocin induction group

Control group BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant at term,
• Giving birth vaginally,
• Birth weight ≥2500gr,
• Participants with a single and healthy fetus and their newborns

You may not qualify if:

• Mentally incompetent,
• Having a high-risk pregnancy,
• Those with risky newborns

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32316794 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sena Dilek Aksoy, Ph.D.

  Kocaeli University

  PRINCIPAL INVESTIGATOR

• Seda Yazici Yel, M.Sc.

  Darica Farabi Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: January 20, 2023
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)