CompletedNot Applicable

Effect of Auricular Vagus Nerve Stimulation on Pain and Symptoms in Primary Dysmenorrhea

Turkey (Türkiye)40 participantsStarted 2023-06-01

Plain-language summary

This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on menstrual pain, pain threshold, depression, anxiety, menstrual symptoms, premenstrual syndrome, and functional and emotional impact of dysmenorrhea in young adult women with primary dysmenorrhea.

Who can participate

Age range

18 Years – 25 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female participants aged 18 years and older * Diagnosed with primary dysmenorrhea (PD) * Having regular menstrual cycles within the last 6 months * Reporting menstrual pain intensity of at least 40 mm on the Visual Analog Scale (VAS) * Willingness to participate in the study and providing informed consent Exclusion Criteria: * Diagnosis of secondary dysmenorrhea * Irregular menstrual cycles * Menstrual cycle length shorter than 21 days or longer than 35 days * History of pregnancy or childbirth, or current pregnancy * Use of intrauterine device (IUD) or oral contraceptives * Current use of sedative, analgesic, anti-inflammatory, or psychotropic medication * History of pelvic surgery or presence of pelvic pathology * Presence of chronic, systemic, cardiovascular, or neurological diseases (e.g., diabetes mellitus, hypoglycemia, bradycardia, hypotension, hypotonic disorders, etc.) * Presence of ear implants, ear wounds, or ear infections * Presence of implanted electronic devices such as pacemakers

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Menstrual pain intensity

Timeframe: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).

Pain threshold

Timeframe: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).

Trial details

NCT IDNCT07683637

SponsorIstanbul Gelisim University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-30

View on ClinicalTrials.gov More Primary Dysmenorrhea (PD) trials

Plain-language summary

Who can participate

Age range

18 Years – 25 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Menstrual pain intensity

Timeframe: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).

Pain threshold

Timeframe: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).