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

Not Applicable

Completed

• Conditions: Dysmenorrhea Primary; Pain
• Interventions: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

• Registration Number: NCT06146569
• Lead Sponsor: Artvin Coruh University

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-13
• Study Start: 2023-11-15
• Study First Submitted QC: 2023-11-22
• Study First Posted: 2023-11-24
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous Auricular Vagus Nerve Stimulation	Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)	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.
Sham Transcutaneous Auricular Vagus Nerve Stimulation	Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)	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.

Primary Outcome Measures

Name	Time	Method
Pain Pressure Threshold	Immediately after the intervention	To measure the pressure pain threshold, it will be used a Push-Pull Force Gauge® (1200-304) will be used by Fabrication Enterprises, Inc. This handheld algometer allows linear force application ranging between 0 and 10 kg (22 lb × ¼ lb and 10 kg × 100 g). Initially, two exercises will be performed on the extensor muscles of the dominant forearm so that patients can become familiar with the equipment. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point will be evaluated three times, and the average value will be recorded. The measurement will be performed on five reference points in the abdomen and one reference point in the lumbar spine, as in a previous study where pain was evaluated in PD.
Pain Intensity	On the 3rd day of menstruation when the intervention occurred	Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.

Secondary Outcome Measures

Name	Time	Method
6-Minute Walk Test (6MWT)	Immediately after the intervention	The 6-Minute Walk Test (6MWT) will evaluate submaximal functional capacity. 6MWT measures the maximum distance participants can walk as quickly as possible for 6 minutes.
Hamilton Anxiety Scale (HAM-A)	Immediately after the intervention	Patients with chronic pain often experience mood disorders, such as depression and anxiety. The Hamilton Anxiety Scale (HAM-A) will be used to assess the intensity of anxiety symptoms. The scale measures both mental and physical anxiety with 14 symptom-defined items. Each item is scored from 0 (not present) to 4 (severe). The total score range is 0-56. On the anxiety scale, scores of 17 or below indicate mild anxiety, while scores of 18-24 indicate moderate anxiety, and scores of 25-30 indicate severe anxiety.
Functional and Emotional Measure of Dysmenorrhea (FEMD)	Immediately after the intervention	Functional and Emotional Measure of Dysmenorrhea (FEMD), consisting of 14 items, evaluates dysmenorrhea functionally and emotionally with a 5-point Likert-type item. The reliability and validity study of the scale developed in 2012 was conducted in Turkey in 2015. As the scores obtained from the scale with a minimum score of 14 and a maximum score of 70 increase, the functional and emotional impact of dysmenorrhea also increases.
Menstrual Symptom Scale (MSS)	Immediately after the intervention	The scale consists of 22 items and uses a 5-point Likert-type format. Participants are asked to rate the severity of their menstrual symptoms on a scale of 1 (never) to 5 (always). The scale contains three subscales: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The maximum score on the scale is 110, and the minimum score is 22. MSS score is calculated by taking the average score of all items in the scale. High scores are associated with increased menstrual symptoms.
Positive and Negative Affect Schedule (PANAS)	Immediately after the intervention	For taVNS administration, the positive and negative affect will be assessed before and after treatment using the Positive and Negative Affect Schedule (PANAS). This 5-point Likert-type scale was developed in 1988 and includes 20 items: 10 positive and 10 negative. A score range of 10-50 assesses both positive and negative effects.

Trial Locations

Locations (1)

Zeynep Yıldız Kızkın; 🇹🇷 Artvin, Turkey