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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Intervention Name: Transauricular Vagus Nerve Stimulation (taVNS) Intervention Description: Participants will receive transauricular vagus nerve stimulation on the tragus. Frequency: 2 sessions per day (one at 10 AM and one at 6 PM). Duration: Each session will last 15 minutes. Treatment Cycle: Stimulation will be applied for 5 days each month, starting 2 days before the expected beginning of the menstrual cycle, for a total of 2 months. The participants will adjust the level of maximum stimulation they considered painless.
Intervention Name: SHAM stimulation of the earlobe. Participants will receive SHAM stimulation on the earlobe, which does not stimulate the vagus nerve. Frequency: 2 sessions per day (one at 10 AM and one at 6 PM). Duration: Each session will last 15 minutes. Treatment Cycle: Placebo stimulation will be applied for 5 days each month, starting 2 days before the expected beginning of the menstrual cycle, for a total of 2 months. The participants will adjust the level of maximum stimulation they considered painless.
UESTC
Chengdu, Sichuan, China
RECRUITINGReduction the use of rescue medications
Significative reduction in the number of cases of rescue medication after the treatment employing the taVNS in respect to the sham condition.
Time frame: During the first 3 days of menstrual
Reduction in acute and mean menstrual pain severity
Significative reduction in acute and mean (across the 3 days) menstrual pain severity assessed via Numeric Rating Scale (NRS) after the treatment employing the taVNS in respect to the sham condition.
Time frame: During the first 3 days of menstrual
Reduction in menstrual pain severity at the Short form McGill Pain Questionnarie
Reduction in menstrual pain severity employing using the Short form McGill pain questionnaire during the experimental condition in comparison to the sham condition
Time frame: During the first 3 days of menstrual
Changes in affective symptoms
Decrease of the score in at least one if the following scale: in Trait Anxiety Inventory (STAI), Beck's Depression Inventory II, Positive and Negative Affect Schedule (PANAS) and Pain Catastrophizing Scale (PCS).
Time frame: First day of stimulation, last day of stimulation.
Changes in fMRI signal in the mesocorticolimbic system
Changes in fMRI signal in the areas of the mesocorticolimibic system during the execution of a reward fMRI task (Monetary incentive delay task, Kuntson et al., 2001).
Time frame: After the first month application of the taVNS and of the SHAM stimulation
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