Effects of Interferential Current and Kinesio Taping Added to Pelvic Floor Muscle Exercises in Women With Primary Dysmenorrhea: A Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Short-Form McGill Pain Questionnaire
研究概览
简要总结
Primary dysmenorrhea can adversely affect pain, sleep, and health-related quality of life in young women. This study will investigate and compare the effects of interferential current (IFC) and Kinesio taping (KT) added to pelvic floor muscle exercise (PFME) in women with primary dysmenorrhea. The study will be designed as a three-arm randomized controlled trial. A total of 60 women aged 18-30 years will be recruited and randomly allocated to one of three groups: PFME+IFC, PFME+IFC+KT, or PFME alone. Pain will be assessed using the Short-Form McGill Pain Questionnaire and a pain body diagram, sleep quality will be evaluated using the subjective sleep quality component of the Pittsburgh Sleep Quality Index, and health-related quality of life will be assessed using the SF-36.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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
- •The inclusion criteria were being 18-30 years of age, having regular menstrual cycles, having a diagnosis of primary dysmenorrhea, reporting menstrual pain greater than 4/10 on the Visual Analog Scale (VAS) during the previous 6 months
排除标准
- •conditions associated with secondary dysmenorrhea, such as endometriosis, adenomyosis, uterine fibroids, or endometrial polyps; a history of pelvic infection; use of an intrauterine device or oral contraceptives; previous pregnancy or childbirth; presence of a cardiac pacemaker; pelvic floor dysfunction related to a neurological disorder; and inability to provide informed consent
研究组 & 干预措施
PFMT and ınterferential current and kinesiotaping
干预措施: pelvic floor muscle training (Other)
PFMT and ınterferential current and kinesiotaping
干预措施: Interferential current (Other)
PFMT and ınterferential current and kinesiotaping
干预措施: Kinesio taping (Other)
PFMT
干预措施: pelvic floor muscle training (Other)
PFMT and ınterferential current
干预措施: pelvic floor muscle training (Other)
PFMT and ınterferential current
干预措施: Interferential current (Other)
结局指标
主要结局
Short-Form McGill Pain Questionnaire
时间窗: First day of the first menstrual cycle, first day of the second menstrual cycle, and first day of the third menstrual cycle
Pain characteristics were assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The questionnaire consists of 15 pain descriptors, including 11 sensory and 4 affective items. Each descriptor is scored from 0 (none) to 3 (severe), with higher total scores indicating greater pain severity. The validity and reliability of the Turkish version have been established
pain body diagram
时间窗: First day of the first menstrual cycle, first day of the second menstrual cycle, and first day of the third menstrual cycle
The distribution of pain was assessed using a standardized body diagram on which participants marked the anatomical regions in which they experienced pain. For the present study, the total pain body diagram score was calculated as the total number of regions marked as painful.
Pittsburgh Sleep Quality Index
时间窗: First day of the first menstrual cycle, first day of the second menstrual cycle, and first day of the third menstrual cycle
Subjective sleep quality was assessed using the subjective sleep quality component of the Pittsburgh Sleep Quality Index (PSQI). The PSQI comprises seven components assessing different aspects of sleep, with higher scores indicating poorer sleep quality. The validity and reliability of the Turkish version have previously been established (Ağargün et al., 1996). In the present study, only the subjective sleep quality component was included in the analysis.
SF-36
时间窗: First day of the first menstrual cycle, first day of the second menstrual cycle, and first day of the third menstrual cycle
Health-related quality of life was assessed using the SF-36 Health Survey. The instrument assesses eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, and general health. The health change item was also evaluated. Domain scores range from 0 to 100, with higher scores indicating better perceived health status. The validity and reliability of the Turkish version have been established
次要结局
未报告次要终点
研究者
mehtap kilicoz
PhD
Istanbul Medipol University Hospital