Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea
NCT06146569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-10-29
Summary
This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on pain, functional and emotional symptoms, and physical performance in individuals with primary dysmenorrhea (PD).
Conditions
- Dysmenorrhea Primary
- Pain
Interventions
- DEVICE
-
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Current will be applied bilaterally from the tragus and turbinate parts of the ear with the VagustimTM device. The current frequency to be used in modulation mode is 10 Hz, and the pulse width is 300 μs (In modulation mode, the pulse rate and width are automatically changed in a loop pattern. The pulse width is reduced by 50% from its original setting in 0.5 seconds; then, the pulse rate is changed in 0.5 seconds, reduced by 50% from the original setting. Total cycle time is 1 second.). The current intensity will be applied for 5 minutes, keeping the current constant where the participant feels comfortable.
- DEVICE
-
Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
For 5 minutes, sham applications will be applied using a current-free headset specifically designed for this purpose. Participants will observe the device's functionality, but it will not supply any current.
Sponsors & Collaborators
-
Artvin Coruh University
lead OTHER
Principal Investigators
-
Zeynep Yıldız Kızkın, Lecturer · Artvin Coruh University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-15
- Primary Completion
- 2024-01-15
- Completion
- 2024-01-30
Countries
- Turkey (Türkiye)
Study Locations
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