Effect of Progressive Muscle Relaxation Exercise on RLS Severity, Quality of Life and Sleep Quality in Menopausal Women With Restless Legs Syndrome (RLS): A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Restless Legs Syndrome Severity
研究概览
简要总结
Restless legs syndrome is a symptom that can be seen in all stages of a woman's life, but its frequency and severity increases with menopause. Restless legs syndrome is a neurological problem that occurs usually at night with an irresistible urge to move the legs. It is a progressive muscle relaxation exercise. Progressive muscle relaxation exercise is a systematic practice aimed at providing deep relaxation by exercising large muscle groups in the body along with breathing techniques. This study aims to evaluate the effect of progressive muscle relaxation exercise on the severity of restless legs syndrome, quality of life and sleep quality related to restless legs syndrome in menopausal women with restless legs syndrome.
详细描述
Menopause, which is a natural part of women's life; It is a condition that occurs between the ages of 45-52 on average and is characterized by hormonal changes and cessation of the menstrual cycle. Many symptoms are observed during menopause, such as hot flashes, sleep problems, mood disorders, sexual dysfunction, weight gain, and decline in cognitive functioning. Restless legs syndrome is another symptom that can be seen in all periods of a woman's life, but its frequency and severity increases with menopause. Restless legs syndrome is a neurological problem that occurs usually at night with an irresistible urge to move the legs. There are studies reporting that sleep problems, which are a common problem during the menopausal period, worsen with the addition of restless legs syndrome. Restless legs syndrome and sleep problems are two important factors that negatively affect the quality of life of women in the menopausal period. Alternative and complementary therapies are frequently used among the methods used to cope with menopausal symptoms and symptoms triggered by menopause. These methods include hypnosis, body-mind techniques, cognitive behavioral therapies, aromatherapies, and herbal supplements. It is stated that these techniques reduce the stress of women in the menopausal period and are effective in improving their quality of life. One of these methods is progressive muscle relaxation exercise. Progressive muscle relaxation exercise is a systematic practice that aims to provide deep relaxation by exercising large muscle groups in the body along with breathing techniques. There are studies reporting that PCGE is used effectively in coping with menopausal symptoms. This study aims to evaluate the effect of progressive muscle relaxation exercise on the severity of restless legs syndrome, quality of life and sleep quality related to restless legs syndrome in menopausal women with restless legs syndrome.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having entered natural menopause
- •At least 1 year has passed since the last menstrual period
- •Not having any psychiatric disease
- •Not having any communication problems (mental, auditory, visual, etc.)
排除标准
- •Women not performing post-test applications
- •Not doing progressive muscle relaxation exercises twice in a row.
- •Wants to quit the research.
- •The woman is hospitalized
- •Inability to reach women during follow-ups
结局指标
主要结局
Restless Legs Syndrome Severity
时间窗: Change from Baseline RLS Severity at 8 weeks
Measurements will be made using the RLS Severity Rating Scale. A total score is obtained, with the entire score range varying between 0 and 40; A score between 1-10 indicates mild disease, a score between 11-20 indicates moderate disease, a score between 21-30 indicates severe disease, and a score between 31-40 indicates very severe disease.
Quality of life associated with restless legs syndrome
时间窗: Change from Baseline Quality of Life at 8 weeks
Measurements will be made using the Johns Hopkins Restless Leg Syndrome Quality of Life Scale. The lowest score from the scale is 0 and the highest score is 100. As the score obtained from the scale decreases, it indicates that the quality of life associated with restless legs syndrome is poor.
Quality of sleep associated with restless legs syndrome
时间窗: Change from Baseline Quality of Life at 8 weeks
Measurements will be made using the Pittsburg Sleep Quality Index.A high total score indicates poor sleep quality. Total score is between 0-21. The index does not indicate the presence or frequency of sleep disturbances. However, a PSQI total score of 5 or above indicates poor sleep quality. The cut-off score indicating poor sleep quality is accepted as 5.
次要结局
未报告次要终点
研究者
Pinar Akbas
assistant professor doctor
Gazi University