Actively Recruiting
Pain Relief From Dysmenorrhea Employing taVNS
Led by University of Electronic Science and Technology of China · Updated on 2025-04-04
20
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Pain Relief From Dysmenorrhea Employing taVNS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Regular menstrual cycle (28 days �b1 7 days)
- Moderate menstrual pain with a score of 4 to 7 on the Numerical Rating Scale
- History of using over-the-counter pain relief medication for menstrual pain, at least 1 dose of ibuprofen during the first two days
- Having had 4 consecutive monthly menstrual cycles
- Not pregnant
- Agree to use effective birth control during the study
- Generally healthy
- Agree not to participate in any other clinical trial during this study
- No facial or ear pain, recent ear trauma, or metal implants including pacemakers
- Normal ECG, heart rate, and blood pressure (systolic 105-130, diastolic 60-90, heart rate 60-85 at rest)
You will not qualify if you...
- Currently taking any medications except for pain relief during menstruation
- Use of oral contraceptives
- Dysmenorrhea caused by other conditions such as endometriosis, adenomyosis, uterine fibroids, or infection
- Unstable or serious illnesses like kidney, liver, digestive, heart, lung, thyroid, or psychological disorders; diabetes; hypertension; bleeding disorders; recent surgery; or use of blood thinners
- Current or recent cancer treatment within 2 years
- Pregnant or breastfeeding
- Active smoking, nicotine use, or drug abuse
- Chronic alcohol use exceeding 14 drinks per week
- Any condition that the investigator believes makes participation unsuitable
- Unable or unwilling to follow the study protocol
- Active urinary or genital infections within the last 4 weeks
- Unable to read or understand the consent form
- Unwilling to complete study procedures
- Participation in another clinical trial within the past month
- Personal or family history of seizures, mood, or heart disorders
- Allergic reaction to surface electrodes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UESTC
Chengdu, Sichuan, China, 611731
Actively Recruiting
Research Team
S
Stefania Ferraro, PhD
CONTACT
J
Jaili He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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