Primary Dysmenorrhea (PD)tcVNS-PDNCT07880080
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
A study testing Transcutaneous Cervical Vagus Nerve Stimulation in people with Primary Dysmenorrhea (PD) and Menstrual Pain, run by Sinop University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea (PD), Menstrual Pain
- What is being tested?
- Transcutaneous Cervical Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18-30 years.
- History of primary dysmenorrhea for at least 6 months.
- Menstrual pain intensity of ≥4 on the 0-10 Numerical Rating Scale during the first 24-48 hours of menstruation in at least two of the previous three menstrual cycles.
- Regular menstrual cycles of 21-35 days.
- Menstrual duration of 3-7 days.
- At least 2 years since menarche.
- Ability to understand and perform the study procedures.
- Provision of written informed consent.
Who cannot join
- Diagnosis or history suggestive of secondary dysmenorrhea, including endometriosis, uterine fibroids, ovarian cysts, or pelvic inflammatory disease.
- Pregnancy, suspected pregnancy, or breastfeeding.
- Presence of a cardiac pacemaker, implantable cardioverter-defibrillator, or other active electronic implant.
- Cardiac arrhythmia.
- History of epilepsy, unexplained syncope, or serious neurological disease.
- Wound, infection, dermatological disorder, or metal implant in the cervical stimulation area.
- Regular use of beta-blockers, antiarrhythmic drugs, or medications known to substantially affect heart rate variability.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Primary Dysmenorrhea (PD), Menstrual Pain
- Being tested
- Transcutaneous Cervical Vagus Nerve Stimulation, Sham Transcutaneous Cervical Vagus Nerve Stimulation
- Keywords
- Primary Dysmenorrhea, Menstrual Pain, Transcutaneous Cervical Vagus Nerve Stimulation, Vagus Nerve Stimulation, Neuromodulation, Heart Rate Variability
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Cervical Vagus Nerve StimulationDevice
Also called tcVNS, Pulsetto Fit
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 StimulationDevice
Also called Sham 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.
| Study group | Role | What they receive |
|---|---|---|
| Active tcVNS | Experimental | 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. Receives: Device: Transcutaneous Cervical Vagus Nerve Stimulation |
| Sham tcVNS | Sham comparator | 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. Receives: Device: Sham Transcutaneous Cervical Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily from Day 1 through Day 5 of the menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the active transcutaneous cervical vagus nerve stimulation (tcVNS) group or the sham stimulation group. Each participant will remain in the assigned group throughout the study, and both groups will follow the same assessment schedule.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEFA HAKTAN HATIK, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880080
- Sponsor's protocol ID
- tcVNS-PD-2026-01
- Acronym
- tcVNS-PD
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Unal E. Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Menstrual Symptoms in Primary Dysmenorrhea: A Placebo-Controlled Study. J Midwifery Womens Health. 2026 Jun 7. doi: 10.1111/jmwh.70138. Online ahead of print.
PubMed 42252834Wang C, Su W, Feng X, Qi X, Hong Z, Dun W, Zhang M, Liu J. Transcutaneous auricular vagus nerve stimulation for the treatment of primary dysmenorrhea: A pilot study. Brain Stimul. 2023 May-Jun;16(3):695-697. doi: 10.1016/j.brs.2023.04.010. Epub 2023 Apr 17. No abstract available.
PubMed 37076044Yildiz Kizkin Z, Yildiz R, Ozden AV. Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals with Primary Dysmenorrhea: A Randomized Controlled Trial. Neuromodulation. 2026 Jun;29(4):576-587. doi: 10.1016/j.neurom.2025.09.306. Epub 2025 Oct 17.
PubMed 41108303
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07880080
- Acronym / sponsor ID
- tcVNS-PD / tcVNS-PD-2026-01
- Conditions
- Primary Dysmenorrhea (PD), Menstrual Pain
- Keywords
- Primary Dysmenorrhea, Menstrual Pain, Transcutaneous Cervical Vagus Nerve Stimulation, Vagus Nerve Stimulation, Neuromodulation, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the active transcutaneous cervical vagus nerve stimulation (tcVNS) group or the sham stimulation group. Each participant will remain in the assigned group throughout the study, and both groups will follow the same assessment schedule.
| Arm | Type | Receives |
|---|---|---|
| Active tcVNS | Experimental | Device: Transcutaneous Cervical Vagus Nerve StimulationParticipants 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. |
| Sham tcVNS | Sham comparator | Device: Sham Transcutaneous Cervical Vagus Nerve StimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female participants aged 18-30 years.
- History of primary dysmenorrhea for at least 6 months.
- Menstrual pain intensity of ≥4 on the 0-10 Numerical Rating Scale during the first 24-48 hours of menstruation in at least two of the previous three menstrual cycles.
- Regular menstrual cycles of 21-35 days.
- Menstrual duration of 3-7 days.
Key exclusion criteria (7 listed)
- Diagnosis or history suggestive of secondary dysmenorrhea, including endometriosis, uterine fibroids, ovarian cysts, or pelvic inflammatory disease.
- Pregnancy, suspected pregnancy, or breastfeeding.
- Presence of a cardiac pacemaker, implantable cardioverter-defibrillator, or other active electronic implant.
- Cardiac arrhythmia.
- History of epilepsy, unexplained syncope, or serious neurological disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Cervical Vagus Nerve StimulationAlso: tcVNS, Pulsetto FitBilateral 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. | Device | Active tcVNS |
| Sham Transcutaneous Cervical Vagus Nerve StimulationAlso: Sham tcVNS, Pulsetto FitParticipants 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. | Device | Sham tcVNS |
Primary outcome
Change in Menstrual Pain Intensity Assessed by the Numerical Rating Scale
Time frame: Baseline (Day 1 before the first intervention) through Day 5 of the menstrual cycle
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.
Change in Multidimensional Menstrual Pain Assessed by the Short-Form McGill Pain Questionnaire
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
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.
6 secondary outcomes
Change in Functional and Emotional Impact of Dysmenorrhea
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Change in Anxiety Symptoms
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Change in Depressive Symptoms
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Change in Menstrual Symptom Severity
Time frame: Baseline (Day 1 before intervention) and Day 3 after the final intervention
Change in Autonomic Function Assessed by Heart Rate Variability
Time frame: Day 1 before intervention, immediately after the first intervention, and Day 3 after the final intervention
Analgesic Use During Menstruation
Time frame: Daily from Day 1 through Day 5 of the menstrual cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Results publication: PubMed 42252834Unal E. Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Menstrual Symptoms in Primary Dysmenorrhea: A Placebo-Controlled Study. J Midwifery Womens Health. 2026 Jun 7. doi: 10.1111/jmwh.70138. Online ahead of print.
- Results publication: PubMed 37076044Wang C, Su W, Feng X, Qi X, Hong Z, Dun W, Zhang M, Liu J. Transcutaneous auricular vagus nerve stimulation for the treatment of primary dysmenorrhea: A pilot study. Brain Stimul. 2023 May-Jun;16(3):695-697. doi: 10.1016/j.brs.2023.04.010. Epub 2023 Apr 17. No abstract available.
- Results publication: PubMed 41108303Yildiz Kizkin Z, Yildiz R, Ozden AV. Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals with Primary Dysmenorrhea: A Randomized Controlled Trial. Neuromodulation. 2026 Jun;29(4):576-587. doi: 10.1016/j.neurom.2025.09.306. Epub 2025 Oct 17.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Cervical Vagus Nerve Stimulation in people with Primary Dysmenorrhea (PD) and Menstrual Pain, run by Sinop University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEFA HAKTAN HATIK, PhD, MSc, Physiotherapist (+90 505 876 1553, haktanhtk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Menstrual Pain Intensity Assessed by the Numerical Rating Scale (time frame: Baseline (Day 1 before the first intervention) through Day 5 of the menstrual cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07880080, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.