Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain Pressure Threshold
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Throughout the study, participants and researchers involved in assessments and interventions will remain blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Pain Pressure Threshold
时间窗: 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
时间窗: 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.
次要结局
- 6-Minute Walk Test (6MWT)(Immediately after the intervention)
- Hamilton Anxiety Scale (HAM-A)(Immediately after the intervention)
- Functional and Emotional Measure of Dysmenorrhea (FEMD)(Immediately after the intervention)
- Menstrual Symptom Scale (MSS)(Immediately after the intervention)
- Positive and Negative Affect Schedule (PANAS)(Immediately after the intervention)
研究者
Zeynep Yıldız Kızkın
Lecturer
Artvin Coruh University