Newborn Pain and Stress Levels in Oxytocin Induction at Birth
NCT ID: NCT06474000
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
164 participants
INTERVENTIONAL
2023-01-20
2023-12-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
Oxytocin induction group
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.
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.
Control group
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.
Interventions
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Oxytocin induction group
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.
Control group
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.
Eligibility Criteria
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Inclusion Criteria
* Giving birth vaginally,
* Birth weight ≥2500gr,
* Participants with a single and healthy fetus and their newborns
Exclusion Criteria
* Having a high-risk pregnancy,
* Those with risky newborns
18 Years
40 Years
FEMALE
Yes
Sponsors
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Kocaeli University
OTHER
Responsible Party
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sena dilek
Principal Investigator
Principal Investigators
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Sena Dilek Aksoy, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kocaeli University
Seda Yazici Yel, M.Sc.
Role: STUDY_CHAIR
Darica Farabi Training and Research Hospital
Locations
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Kocaeli University
Kocaeli, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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sdilek8
Identifier Type: -
Identifier Source: org_study_id
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