Vagus Nerve Stimulation and Labor

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-25

Study Completion Date

2025-04-10

Brief Summary

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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

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Detailed Description

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Conditions

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36-40 haftalık Hamile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

In the study, hormone value analyses, statistics and reporting will be blinded. Before the pre-tests are collected in the collection of data, the responsible researcher will contact the statistician who performed the randomization and reach the randomization list. After learning the group information, the responsible researcher will start the application. The participant will be monitored under the supervision of the responsible researcher until they go to the postpartum care unit. A new participant will be included in the study after the participant is sent to the postpartum care clinic. Therefore, the intervention and control groups will be prevented from seeing each other.

For hormone analyses, the hormone tubes will be coded as "A" and "B" groups by the responsible researcher. Hormone value analyses will be performed by an expert laboratory technician who is not aware of the groups independent of the study.

Study Groups

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Intervention Group

Vagus nerve stimulation based on polyvagal theory and routine application

Group Type ACTIVE_COMPARATOR

Vagal Active Tone Application Procedure

Intervention Type OTHER

First section; A video will be created that includes pictures and visuals describing the vagus nerve, explaining its benefits, and providing information about its effects and usage during the birth process.

Second section; Deep breathing and focus exercises;

Feather Breath:

Candle Breath: The pregnant woman inhaled and exhaled as if she was trying to blow out a candle.

Relaxation Breath: Deep breath Third section; Body relaxation exercises; Fourth section; Facial muscle relaxation exercises; Fifth section; Neck and larynx muscle relaxation exercises;

Control Group

Routine maintenance; Routine care and treatment of women will continue during data collection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vagal Active Tone Application Procedure

First section; A video will be created that includes pictures and visuals describing the vagus nerve, explaining its benefits, and providing information about its effects and usage during the birth process.

Second section; Deep breathing and focus exercises;

Feather Breath:

Candle Breath: The pregnant woman inhaled and exhaled as if she was trying to blow out a candle.

Relaxation Breath: Deep breath Third section; Body relaxation exercises; Fourth section; Facial muscle relaxation exercises; Fifth section; Neck and larynx muscle relaxation exercises;

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes