Erciyes University Faculty of Health Sciences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- RLS Severity Rating Scale
研究概览
简要总结
Sleep disorders are important to place among the symptoms frequently seen in hemodialysis patients. Among sleep disorders, restless legs syndrome is the most common. Restless legs syndrome, seen in patients receiving hemodialysis treatment, causes excessive daytime sleepiness and negatively affects the sleep quality of individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double-blind study design
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who are 18 years or older,
- •Not pregnant and not planning a pregnancy,
- •Having been diagnosed with restless leg syndrome according to the restless leg syndrome diagnostic scale and by a physician,
- •Having at least mild restless leg syndrome according to the restless leg syndrome severity rating scale,
- •Scoring 11 or above on the Epworth sleepiness scale,
- •PSQI score an average of 5 and above,
- •Receiving hemodialysis treatment in hemodialysis units for at least 3 months and 3 sessions per week,
- •Continuing dialysis treatment in the same institution,
- •Able to walk independently,
- •No changes in the treatment program before the massage and throughout the research process,
- •Not having any allergies to the oils to be used,
- •Individuals who can understand and communicate with Turkish will be included in the research
排除标准
- •Those who are sensitive and/or have any allergies to the lavender oil to be used,
- •Those who have lower leg problems that would prevent them from applying massage to the lower leg area,
- •Have a history of mental or physical disability, including peripheral neuropathy, vascular problems in the legs,
- •Epilepsy, Alzheimer's, Parkinson's, Multiple Sclerosis, etc. Those with a diagnosed neurological disease such as
- •Pre-implemented,
- •Those with respiratory system disorders,
- •Patients who used other complementary and integrative therapies methods during the study period will be excluded from the study
结局指标
主要结局
RLS Severity Rating Scale
时间窗: Change compared to the initial score 1 month after aromatherapy massage application
The RLS Severity Rating Scale was developed in 2003. The scale was applied in the selection of patients and in the weekly evaluation of RLS severity. The scale comprised ten questions; each question was scored between 0 and 4. Questions 1, 2, 4, 6, 7, and 8 were related to RLS symptoms, questions 5, 9, and 10 were related to the effect of the disease on the mental state and daily social activities of patients with RLS, and question 3 was about the diagnostic criteria of RLS. The overall score indicated the RLS severity. A minimum score of 0 and a maximum score of 40 could be obtained. A score between 1 and 10 corresponded to "mild," 11-20 "moderate," 21-30 "severe," and 31-40 "very severe" RLS.
Epworth Sleepiness Scale
时间窗: Change compared to the initial score 1 month after aromatherapy massage application
Daytime sleepiness is determined with the scale developed in 1991. The scale consists of 8 questions in total and a high score from the scale indicates an increased level of daytime sleepiness. With this four-point Likert type scale, each question is rated between 0-3. In the evaluation of the scale; 0-5 points: normal, 6-10 points: normal but increased daytime sleepiness, 11-12 points: increased moderate daytime sleepiness, 13-15 points: increased moderate daytime sleepiness, 16-24 points: increased severe daytime sleepiness It is considered as sleepiness. The minimum score is 0, the maximum score is 24, and a total score of 11 or above indicates excessive daytime sleepiness of individuals.
次要结局
- Pittsburg Sleep Quality Index (PSQI)(Change compared to the initial score 1 month after aromatherapy massage application)
研究者
Ayser DÖNER
Research assistant (Principal Investigator)
TC Erciyes University