An interventional study of Transcutaneous Cervical Vagus Nerve Stimulation and Sham Transcutaneous Cervical Vagus Nerve Stimulation in Primary Dysmenorrhea (PD) and Menstrual Pain, sponsored by Sinop University. Not yet recruiting. Open to female participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Sinop University · Not applicable, Interventional, and Treatment
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.
This study is designed as a randomized, sham-controlled, parallel-group clinical trial to evaluate the effects of bilateral transcutaneous cervical vagus nerve stimulation (tcVNS) in women with primary dysmenorrhea. Eligible participants will be women aged 18-30 years with a history of primary dysmenorrhea for at least 6 months, regular menstrual cycles, and menstrual pain intensity of at least 4 on an 11-point Numerical Rating Scale during the first 24-48 hours of menstruation in at least two of the previous three menstrual cycles.
A total of 70 participants will be randomly allocated in a 1:1 ratio to either an active tcVNS group or a sham stimulation group. Participants in the active group will receive bilateral cervical vagus nerve stimulation using the Pulsetto Fit neuromodulation device. The device will be positioned bilaterally over the cervical vagus nerve trajectory in the neck, and conductive gel will be applied to the electrode surfaces. Stimulation will be administered once daily for 8 minutes during the first three days of menstruation. The stimulation intensity will be individually adjusted to a sensory threshold that produces a clearly perceptible tingling or vibration without pain, muscle contraction, or discomfort. The standard "Pain" protocol available in the Pulsetto mobile application will be used.
Participants in the sham group will follow the same application procedure using a Pulsetto Fit device with the same physical appearance, conductive gel, mobile application interface, and session duration. However, no therapeutic electrical current will be delivered during sham stimulation. The first session will be conducted under investigator supervision, whereas the second and third sessions will be self-administered by participants at home after appropriate training.
Participants will be followed for five days during one menstrual cycle. Outcome assessments will include menstrual pain intensity measured using the Numerical Rating Scale, multidimensional pain characteristics assessed with the Short-Form McGill Pain Questionnaire, functional and emotional effects of dysmenorrhea, anxiety and depression symptoms, menstrual symptoms, analgesic use, and autonomic function assessed by heart rate variability. Heart rate variability will be recorded using a Polar H10 chest strap during standardized 5-minute recordings and analyzed using Kubios HRV software. The parameters of interest will include RMSSD, SDNN, LF/HF ratio, and mean heart rate.
Clinical and questionnaire-based outcomes will be assessed at predefined time points during the menstrual cycle, and daily pain intensity, analgesic use, treatment completion, and adverse events will also be recorded. The study will compare changes over time between the active tcVNS and sham groups.
401 studies on the registry are indexed under Dysmenorrhea; 94 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 336 interventional studies indexed under Dysmenorrhea.
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Exclusion Criteria:
Participants will receive bilateral transcutaneous cervical vagus nerve stimulation (tcVNS) using the Pulsetto Fit device once daily for 8 minutes during the first three days of menstruation. 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. The first session will be performed under investigator supervision, and the second and third sessions will be self-administered at home after appropriate training.
Device: 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. Sham stimulation will be administered once daily for 8 minutes during the first three days of menstruation. The first session will be performed under investigator supervision, and the second and third sessions will be self-administered at home.
Device: Sham 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.
Also known as: tcVNS, Pulsetto Fit
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.
Also known as: Sham tcVNS, Pulsetto Fit
Change in Menstrual Pain Intensity Assessed by the Numerical Rating Scale
Menstrual pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. The change in menstrual pain intensity over the study period will be compared between the active tcVNS and sham groups.
Time frame: Baseline (Day 1 before the first intervention) through Day 5 of the menstrual cycle
Change in Multidimensional Menstrual Pain Assessed by the Short-Form McGill Pain Questionnaire
The Short-Form McGill Pain Questionnaire will be used to assess sensory and affective dimensions of menstrual pain. Fifteen pain descriptors are rated from 0 to 3, generating a total score ranging from 0 to 45. Higher scores indicate greater pain severity. The change in total score will be compared between the active tcVNS and sham groups.
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Change in Functional and Emotional Impact of Dysmenorrhea
The functional and emotional impact of dysmenorrhea will be assessed using the Functional and Emotional Measure of Dysmenorrhea. Higher scores indicate greater functional and emotional impairment associated with dysmenorrhea. Changes in scores will be compared between the active tcVNS and sham groups.
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Change in Anxiety Symptoms
Anxiety symptoms will be assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Change in Depressive Symptoms
Depressive symptoms will be assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Scores range from 0 to 21, with higher scores indicating greater depressive symptom severity.
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Change in Menstrual Symptom Severity
Menstrual symptoms including pelvic cramping, low back pain, headache, nausea, vomiting, diarrhea, constipation, fatigue, dizziness, sleep disturbance, irritability, and difficulty concentrating will be rated from 0 (none) to 3 (severe). Changes in symptom severity will be compared between groups.
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Change in Autonomic Function Assessed by Heart Rate Variability
Autonomic function will be assessed using standardized 5-minute RR interval recordings obtained with a Polar H10 chest strap. Recordings will be analyzed using Kubios HRV software. Heart rate variability parameters will include RMSSD, SDNN, LF/HF ratio, and mean heart rate. Changes in these parameters over time will be compared between the active tcVNS and sham groups.
Time frame: Day 1 before intervention, immediately after the first intervention, and Day 3 after the final intervention
Analgesic Use During Menstruation
Use of analgesic medication will be recorded daily, including medication name, dose, and time of administration. Analgesic use will be compared between the active tcVNS and sham groups.
Time frame: Daily from Day 1 through Day 5 of the menstrual cycle
No study locations are listed for this record.
Plan to share: No — Individual participant data sharing is not currently planned. Study data will be stored in coded form and handled in accordance with ethical and institutional data protection requirements.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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