Clinical trial NCT06792357: Vagus Nerve Stimulation and Labor
Official title: Effects of Vagus Nerve Stimulation Based on Polyvagal Theory on Labor Pain, Anxiety, Oxytocin, Cortisol Levels, Labor Duration and Perception
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: 36-40 haftalık Hamile
Keywords: Emek
oksitozin
kortizol
vagus sinir stimülasyonu
Ebe
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This project aimed to determine the effect of vagus nerve stimulation based on Polyvagal theory on labor pain, anxiety, oxytocin, cortisol levels, duration and perception of birth.

In this regard, the planned targets are;

* It is to determine the effect of vagus nerve stimulation on labor pain in pregnant women, based on Polyvagal theory.
* It is to determine the effect of vagus nerve stimulation on the anxiety level of pregnant women, based on the Polyvagal theory.
* It is to determine the effect of vagus nerve stimulation on the oxytocin level of pregnant women, based on the Polyvagal theory.
* It is to determine the effect of vagus nerve stimulation on cortisol levels of pregnant women, based on Polyvagal theory.
* It is to determine the effect of vagus nerve stimulation on the duration of birth of pregnant women, based on the Polyvagal theory.
* It is to determine the effect of vagus nerve stimulation on the birth perception of pregnant women, based on Polyvagal theory.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The vagus nerve innervates both the uterus and the cervix. It is thought that a successful and positive birth experience can be achieved by stimulating the vagus nerve at the desired level. Making instinctive sounds such as singing, humming, and various exercises are methods that stimulate the vagus nerve. In this project, an application protocol based on polyvagal theory and including breathing, relaxation and voice exercises was prepared. Video-supported application material will be developed in line with the prepared protocol. The video-assisted vagus nerve stimulation intervention is called Vagal Active Tone (VAT). VAT is a new method in the literature and for which we have limited information about labor. This project aimed to determine the effect of vagus nerve stimulation based on Polyvagal theory on labor pain, anxiety, oxytocin, cortisol levels, duration and perception of birth. This study was planned as a randomized controlled experimental study. The number of samples was calculated using the G\*power 3.1.9.6 program. After the power analysis, it is aimed to reach a total of 50 people, 25 in the intervention group and 25 in the control group. Data will be collected with Personal Information Form, Labor Monitoring Form, Hormone Levels Monitoring Form, Visual Analogue Scale, State Anxiety Scale, Facial Anxiety Scale and Mother's Birth Perception Scale.

It is aimed to produce new and original evidence-based information with the use of VAT intervention based on polyvagal theory. It is thought that this intervention, which can be easily accessed and applied by pregnant women whenever they want, will contribute positively to labor pain, anxiety, oxytocin and cortisol levels, and the duration and perception of birth.

Keywords: Labor, oxytocin, cortisol, vagus nerve stimulation, midwife


Eligibility criteria: Inclusion Criteria :

Women who volunteer to participate in the study, are primiparous and in the 28-32nd week of pregnancy, Normal vaginal birth, Single fetus and cephalic presentation, 19 years of age or older, Communicate in Turkish will be included in the study.

Exclusion Criteria:

Women with obstetric complications (placenta previa, preeclampsia, premature rupture of membranes, oligohydramnios, polyhydramnios, presentation disorder, intrauterine growth retardation, İntrauterine dead fetus, macrosomic baby, fetal distress, etc.), Have a psychiatric diagnosis, Have a systemic disease, Have a heart and brain pacemaker, Have epilepsy, Have vision and hearing problems, Attend a childbirth preparation class, Undergo medical procedures for any reason at birth will be excluded from the study.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 30 minutes later (post intervention)
measure: Facial Anxiety Scale (FAS)
timeFrame: 30 minutes later (post intervention)
measure: State Anxiety Inventory (SAI)
timeFrame: 30 minutes later (post intervention)
measure: Maternal Birth Perception Scale (MBS)
timeFrame: 30 minutes later (post intervention)
measure: Hormone Values Monitoring Form
timeFrame: 30 minutes later (post intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova Unıversıty
state: Cukurova
Study officials:
References: