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

Overview

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

Interventions

• Other 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;

Primary outcome measures

• Visual Analog Scale (VAS) [Time frame: 30 minutes later (post intervention)]
• Facial Anxiety Scale (FAS) [Time frame: 30 minutes later (post intervention)]
• State Anxiety Inventory (SAI) [Time frame: 30 minutes later (post intervention)]
• Maternal Birth Perception Scale (MBS) [Time frame: 30 minutes later (post intervention)]
• Hormone Values Monitoring Form [Time frame: 30 minutes later (post intervention)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Cukurova Unıversıty — Adana

Identifiers

NCT: NCT06792357 · CukurovaUnv · Project NO: 124S403

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗