Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Assessment of pelvic floor muscle tone.
研究概览
简要总结
This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus.
详细描述
Vaginismus is a common sexual problem with a prevalence of 20% in Egyptian women, that has a significant impact on a person's life, affecting their physical, emotional, and psychological well-being, as well as their relationships and overall quality of life.
There were previous studies that studied the effect of pelvic floor rehabilitation on vaginismus and found that there was a highly significant decrease in pain and pelvic floor muscle spasms, as well as a highly significant increase in sexual function. Also, only one previous protocol explored the effect of interferential current on treating vaginismus. But, till now, there is no prior study that investigated the impact of adding interferential current to pelvic floor muscle training on treating vaginismus. this trial has two groups; one will receive interferential current, and the other group will receive interferential current + pelvic floor muscle training
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women suffer from primary vaginismus with a duration of marriage ranging from 1 to 12 months. They are diagnosed and referred by the gynecologist.
- •Their pain level is ≥ 4 on the visual analogue scale.
- •They have a sedentary lifestyle.
排除标准
- •Vaginismus requiring surgical treatment.
- •Any gynecological diseases such as pelvic organ prolapse, vulvar vestibulitis, vulvar pain, clitorodynia, vulvar dysesthesia, or any pelvic inflammatory diseases.
- •Lower urinary tract infection.
- •Husband with sexual dysfunction that prevents penetration.
- •Diseases involving nerves and muscles, such as myasthenia gravis.
- •Severe psychiatric disorder or cognitive relegation.
结局指标
主要结局
Assessment of pelvic floor muscle tone.
时间窗: Eight weeks
It will be assessed by biofeedback perineometer.
Assessment of pain intensity.
时间窗: Eight weeks
The visual analogue scale (VAS): will be used to measure pain intensity for each woman in both groups. Each woman will be asked to mark the point on the scale that represents her pain level.
Quantification of pressure pain threshold in the perineum.
时间窗: Eight weeks
The pressure pain threshold in the perineum region will be evaluated with a pressure algometer.
次要结局
- Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus.(Eight weeks)
研究者
Rana
Principal Investigator
Cairo University