Clinical Research Directory
Browse clinical research sites, groups, and studies.
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Sponsor: Sinop University
Summary
This randomized, sham-controlled, parallel-group clinical trial will investigate the effects of bilateral transcutaneous cervical vagus nerve stimulation (tcVNS) on menstrual pain and related clinical outcomes in women with primary dysmenorrhea. Seventy women aged 18-30 years will be randomly allocated in a 1:1 ratio to either active tcVNS or sham stimulation. The intervention will be administered once daily for 8 minutes during the first three days of menstruation. Outcomes will include menstrual pain intensity, multidimensional pain characteristics, dysmenorrhea-related functional and emotional symptoms, anxiety and depression, menstrual symptoms, analgesic use, and heart rate variability. Participants will be followed for five days during one menstrual cycle.
Official title: Effects of Transcutaneous Cervical Vagus Nerve Stimulation on Menstrual Pain and Related Clinical Outcomes in Women With Primary Dysmenorrhea: A Randomized Sham-Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 30 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-10-31
Completion Date
2027-03-31
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous Cervical Vagus Nerve Stimulation
Bilateral transcutaneous cervical vagus nerve stimulation will be delivered using the Pulsetto Fit neuromodulation device. The device will be positioned bilaterally over the cervical vagus nerve trajectory in the neck with conductive gel applied to the electrode surfaces. Participants will receive one 8-minute session per day during the first three days of menstruation. The standard "Pain" protocol will be selected through the Pulsetto mobile application. Stimulation intensity will be individually adjusted to a comfortable sensory threshold that produces a clearly perceptible tingling or vibration without pain, muscle contraction, or discomfort.
Sham Transcutaneous Cervical Vagus Nerve Stimulation
Participants will undergo the same application procedure using a Pulsetto Fit device with the same physical appearance, conductive gel, mobile application interface, and session duration as the active intervention. However, no therapeutic electrical current will be delivered (0 mA/non-therapeutic output). Participants will complete one 8-minute sham session per day during the first three days of menstruation.