Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea

Artvin Coruh University

Status: Completed

Conditions: Pain; Dysmenorrhea Primary

Treatments: Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06146569

Vagus Nerve Stimulation

Details and patient eligibility

About

This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on pain, functional and emotional symptoms, and physical performance in individuals with primary dysmenorrhea (PD).

Full description

In this study, which will be conducted over two menstrual cycles, 34 patients with PD will be randomised into two groups: taVNS and sham treatment. From the onset of pain during the menstrual cycle, taVNS or sham treatment will be applied for five days. Pain assessment will be conducted using the Numerical Rating Scale (NRS), pressure pain threshold with an algometer, menstrual symptoms using the Menstrual Symptom Scale (MSS) and the Functional and Emotional Measure of Dysmenorrhea (FEMD), anxiety using the Hamilton Anxiety Scale (HAM-A), and physical performance using the 6-Minute Walk Test (6MWT) during the first and second menstruation.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being diagnosed with PD according to the No. 345 Primary Dysmenorrhea Consensus Guidelines,
• An NRS score of at least three during menstruation before treatment,
• Being a woman between the ages of 18-40,
• A regular menstrual cycle of 28±7 days,
• Being nulliparous,
• No history of brain surgery, tumour or intracranial metal implantation,
• No chronic genitourinary infection or alcohol or drug use.

Exclusion criteria

• History of dizziness or epileptic disease,
• Pregnancy,
• Women with intrauterine devices,
• Metal implants in the head area,
• Women with skin lesions in the area where the electrodes will be placed,
• Use of analgesic drugs during treatment,
• Women with neurological or heart disease,
• Women are diagnosed with gynaecological conditions (endometriosis, adenomyosis, uterine fibroids, etc., which may be associated with secondary dysmenorrhea).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Transcutaneous Auricular Vagus Nerve Stimulation

Experimental group

Description:

Each patient in the Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) group will receive a treatment protocol consisting of taVNS. The treatment will be administered for five days beginning on the first day of pain experienced between the 1st and 2nd menstrual cycles.

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Sham Transcutaneous Auricular Vagus Nerve Stimulation

Sham Comparator group

Description:

Each patient in the sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) group will receive a treatment protocol consisting of sham taVNS. The treatment will be administered for five days beginning on the first day of pain experienced between the 1st and 2nd menstrual cycles.

Treatment:

Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)