Last reviewed · How we verify
NCT06792357
Vagus Nerve Stimulation and Labor
NA trial testing Vagal Active Tone Application Procedure in 36-40 haftalık Hamile in 50 participants. Not yet recruiting.
10 March 2025
Quick facts
| Lead sponsor | Cukurova University |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 50 |
| Start date | 25 January 2025 |
| Primary completion | 10 March 2025 |
| Estimated completion | 10 April 2025 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Vagal Active Tone Application Procedure
Conditions studied
- 36-40 haftalık Hamile — all drugs for 36-40 haftalık Hamile →
Sponsor
Cukurova University
Who can join
Adults 19 to 49, female only, with 36-40 haftalık Hamile. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06792357
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Cukurova University trials
Trials by the same sponsor.
- NCT07464652 — Objectıve Structured Clınıcal Examınatıon Stress For Intravenous Perıpheral Catheterızatıon · NA · not yet recruiting
- NCT07458789 — Breastfeeding Education · NA · not yet recruiting
- NCT07346482 — Determining the Effect of Midwife-Led Safe Infant Care Training for Pregnant Women on Awareness of Sudden Infant Death S · NA · not yet recruiting
- NCT07248904 — The Effect of a Transtheoretical Model-Based Educational Intervention on First-Year Nursing Students' HPV Knowledge, Hea · NA · recruiting
- NCT07241949 — Regional Analgesia Techniques for Laparoscopic Cholecystectomy · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06792357 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cukurova University
- Last refreshed: 24 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06792357.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing