Investigation of the Effectiveness of Reflexologic Magnetic Insoles on Dysmenorrhea Symptoms in Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Menstruation Symptom Questionnaire
研究概览
简要总结
In the study, easy-to-access and easy-to-use reflexologic magnetic insoles were used in women with primary dysmenorrhea who did not want to receive medical treatment; In addition to reducing symptoms such as pain, nausea, dizziness, fainting, vomiting, weakness, constipation/acute gastroenteritis, it is aimed to increase individuals' participation in daily life activities and increase their quality of life by increasing their emotional state.
详细描述
60 women diagnosed with primary dysmenorrhea through examination by a gynecologist will be included in the study. 60 women will be randomly divided into 2 groups. These groups; Reflexologic Magnetic Insoles Sham Group: They will use orthopedic insoles.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with primary dysmenorrhea
- •Visual Analogue Scale (VAS) value is 3 and above
- •The patient has cooperation
- •Having regular menstruation
排除标准
- •Getting pregnant during treatment
- •Using analgesic medication
- •Visual Analogue Scale (VAS) value should be between 0-3
- •Having pain in another part of the body
研究组 & 干预措施
Reflexologic Magnetic Insoles Group
Participants will place the insoles inside their shoes and use them for at least 7 hours a day, every day, for 12 weeks.
干预措施: Reflexologic Magnetic Insole Group (Device)
Orthopedic Insoles Group
Participants will place the insoles inside their shoes and use them for at least 7 hours a day, every day, for 12 weeks.
干预措施: Orthopedic Insole Group (Device)
结局指标
主要结局
Menstruation Symptom Questionnaire
时间窗: 12 weeks
It contains 24 items. It is a 5-point Likert type scale. Participants are asked to evaluate the symptoms that occur during menstruation as a-never (1), b-rarely (2), c-sometimes (3), d-often (4) and e-always (5). The overall score of the scale is calculated by taking the average of the total score obtained from the scale items. A higher score indicates that the symptoms are experienced more clearly.
Menstruation Attitude Questionnaire
时间窗: 12 weeks
Valuated subdimensions include menstruation as a deliberating event, menstruating as a bothersome event, menstruation as a natural event, anticipation and prediction of the onset of menstruation, and denial of any effects of menstruation. The scale is evaluated with a 5-point Likert-type." A high mean score indicates a "positive" attitude toward menstruation.
Visual Analogue Scale (VAS)
时间窗: 12 weeks
The Visual Analogue Scale (VAS) is used to convert non-numerical values to digital. The value 0 means I have no pain, 10 means I have unbearable pain. The person marks his pain on this ruler. It measures the intensity of the pain.
McGill Pain Questionnaire-Short Form:
时间窗: 12 weeks
It evaluates the sensory dimension of pain and the affective dimension of pain. Affective and sensory dimension scores of pain are measured with a Likert-type scale (0-No pain, 3-Severe Pain). The total pain dimension subparametric is the sum of the sensory dimension and the affective dimension of the pain. Total pain intensity is measured with a 6-point Likert-type scale (0-No pain, 5-Unbearable Pain). A high score indicates a high level of pain.
次要结局
未报告次要终点
研究者
gizem boztas
Assistant Professor
Istanbul Medipol University Hospital