NCT06912386 Pain Relief From Dysmenorrhea Employing taVNS
| NCT ID | NCT06912386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Electronic Science and Technology of China |
| Condition | Dysmenorrhea Primary |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-04-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to determine if transauricular vagal nerve stimulation (taVNS) is effective in treating moderate dysmenorrhea. The main question it aims to answer is: • Does taVNS reduce the number of times participants suffering from dysmenorrhea need to use rescue medication during menstruation? Researchers will compare taVNS stimulation with a sham stimulation (a look-alike procedure that does not stimulate the vagus nerve) to assess whether taVNS is effective in treating moderate dysmenorrhea. Participants will: * Undergo taVNS for 2 months and sham stimulation for another 2 months, each for 5 days per month, starting 2 days before the expected beginning of their menstrual cycle. * Visit the clinic twice a month for checkups and tests. * Keep a diary to record their pain levels and the number of times they use rescue medication. * Undergo functional magnetic resonance imagine two times (one after the end of the first use of taVNS and another after the end of the first use of SHAM stimulation).
Eligibility Criteria
Inclusion Criteria: * Regular menstrual cycle (28 days ± 7 days); * Average moderate menstrual pain (with 4 - 7 NRS scores); * History of over-the-counter (OTC) analgesic use for the treatment of menstrual pain (at least 1 IBUPROFEN for the first two days); * 4 consecutive monthly menstrual cycles; * Non-pregnant status; * Agrees to use adequate birth control during the trial; * Otherwise, healthy; * Agree not to participate in any other clinical trial while enrolled in this trial ; * No facial or ear pain, no recent ear trauma, no metal implants including pacemakers; * Normal ECG, Heart Rate and Blood Pressure (systolic BP 105-130, diastolic BP 60-90, heart rate per min at rest 60-85); Exclusion Criteria: * Currently under medications (except for analgesic medication for menstrual cycle); * Use of oral contraceptive; * Secondary cause for dysmenorrhea (i.e., endometriosis, adenomyosis, uterine fibroids, or infection); * Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder, hypertension, any bleeding disorders, recent surgery, or concurrent blood thinning treatment); * Current malignancy or treatment for malignancy within the previous 2 years; * Pregnant or lactating women; * Active smokers, nicotine use, or drug (prescription or illegal substances) abuse; * Chronic past and/or current alcohol use (\>14 alcoholic drinks per week); * Any condition that in the opinion of the investigator, makes the participant unsuitable for inclusion; * Unwilling or unable to comply with protocol; * Active genitourinary infection in the last four weeks; * Unable to read or comprehend the informed consent; * Unwilling to complete study procedures; * Participated in any other clinical trial during the past 1 month; * Personal or family history of seizure, mood, or cardiovascular disorders; * Allergic reaction to surface electrodes.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06912386 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Dysmenorrhea Primary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06912386 currently recruiting?
Yes, NCT06912386 is actively recruiting participants. Contact the research team at stefania@uestc.edu.cn for enrollment information.
Where is the NCT06912386 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06912386 clinical trial?
NCT06912386 is sponsored by University of Electronic Science and Technology of China. The trial plans to enroll 20 participants.