The Effect Of Warm Salt Water and Warm Water Bath Applied to Hands and Feet of Patients With Rheumatoid Arthritis on Pain, Fatigue, Sleep Quality and Functional Capacity,
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Pain Visual Analog Scale
研究概览
简要总结
This pretest-posttest randomized controlled study aimed to determine the effect of warm salt water and warm water bath applied to the hands and feet on pain, fatigue, sleep quality, and functional capacity in patients with rheumatoid arthritis.
The study consisted of three groups. These groups consisted of two intervention groups and one control group. As a result of the power analysis, it was determined that 54 people should be reached. Visual Analog Scale, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, Pittsburgh Sleep Quality Index, and Health Assessment Questionnaire were used in the study. Patients in intervention groups applied a 41°C warm salt and warm water bath three times a week for six weeks in line with the training given. The patients in the control group did not undergo any intervention other than routine treatment and care.
详细描述
The study was conducted at Gulhane Training and Research Hospital Rheumatology Polyclinic, in Turkey. The sample of the study consisted of 54 patients. Eighteen patients in the warm saltwater group were trained using the video demonstration method to make the intervention. Eighteen patients in the lukewarm water group were trained using the video demonstration method to make the intervention. Eighteen patients in the control group were not given any training other than their routine treatment and care. Each patient's pain, fatigue, sleep quality, and functional capacities were measured 24 hours before the intervention. The study lasted six weeks for each patient. The patients in the intervention group performed their interventions three times a week, every other day. The patients were checked by calling every week by phone. Pain, fatigue, sleep quality, and functional capacity of each patient were measured within one week at the latest, after the end of the practices.
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
- Single (Outcomes Assessor)
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
- •18 years or older,
- •Followed up with a diagnosis of RA for at least 1 year,
- •VAS pain score of 5 and above,
- •Volunteer to participate in the research,
- •Disease activity score is low-moderate (DAS28 < 5.1),
- •Patients receiving active treatment (corticosteroid, non-steroidal anti-inflammatory, disease-modifying antirheumatic drugs) for the last 3 months were included in the study.
排除标准
- •- Comorbidity (active malignancy, heart failure or symptomatic ischemic heart disease, severe lung disease, neurologic disease that impairs mobility, uncontrolled thyroid disease, diabetes mellitus)
- •Recent injury or major surgery (within 6 months prior to enrollment)
- •E-joint replacement surgery is planned,
- •Acute infection, fever or vascular disease in the lower and upper extremities,
- •The integrity of the skin on the hands and feet is impaired,
- •Participating in a regular physical therapy or exercise program,
- •pregnant,
- •Diagnosed with sleep apnea
- •VAS pain score below 5,
- •Disease activity score ≥ 5.1,
- •Patients who did not agree to participate in the study were not included in the study.
结局指标
主要结局
Pain Visual Analog Scale
时间窗: It was applied just before the interventions and six weeks after interventions. Change from baseline pain scores at the end of sixth week.
Pain is among the main reasons for rheumatoid arthritis patients to apply to the hospital and seek medical care.
Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire
时间窗: It was applied just before the interventions and six weeks after the interventions. Change from baseline fatigue scores at the end of sixth week.
Fatigue is one of the most common symptoms experienced by rheumatoid arthritis patients and this symptom affects most patients.
次要结局
- Pittsburgh Sleep Quality Index(It was applied just before the interventions and six weeks after interventions. Change from baseline sleep quality scores at the end of sixth week.)
- Health Assessment Questionnaire(It was applied just before the interventions and six weeks after interventions. Change from baseline health assessment scores at the end of sixth week.)
研究者
OKŞAN AKTAŞ
Principal Investigator
Hacettepe University