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Vagus Nerve Stimulation and Labor

Ç

Çukurova University

Status

Not yet enrolling

Conditions

36-40 haftalık Hamile

Treatments

Other: Vagal Active Tone Application Procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT06792357
Project NO: 124S403 (Other Grant/Funding Number)
CukurovaUnv

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

Female

Ages

19 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Intervention Group
Active Comparator group
Description:
Vagus nerve stimulation based on polyvagal theory and routine application
Treatment:
Other: Vagal Active Tone Application Procedure
Control Group
No Intervention group
Description:
Routine maintenance; Routine care and treatment of women will continue during data collection.

Trial contacts and locations

1

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Central trial contact

Rukiye Sülü Dursun Sülü Dursun, PhD student

Data sourced from clinicaltrials.gov

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