The Effect of the Massage on Cramp Frequency, Cramp Severity, and Sleep Quality of Hemodialysis Patients With Complaint of Cramp
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Patient follow-up forms.
研究概览
简要总结
The aim of this randomized controlled experimental study was to determine the effect of the massage applied to hemodialysis patients with complaint of cramp on the cramp frequency, cramp severity, and sleep quality.
详细描述
The study was conducted with patients receiving treatment in a total of four hemodialysis units. The sample of the study comprised a total of 36 patients (18 patients in the intervention group and 18 patients in the control group) with complaint of cramp. In the study, intradialytic massage for lower extremity was applied to the intervention group in three sessions a week and a total of six sessions for two weeks. No intervention other than routine care was applied to the control group patients.
In the study, the data were collected using a patient information form, cramp assessment short survey, the "Visual Analog Scale (VAS)", "Pittsburgh Sleep Quality Index" (PUKİ), and patient follow-up forms.
In order to conduct the study, the necessary Ethics Committee approval and institutional permission were obtained. The individuals included in the study informed about the purpose of the research, their verbal consent obtained and the participant's informed consent form signed.
After the intervention and control groups were assigned according to the research criteria, the days and sessions of the groups were determined and recorded in the digital randomization environment.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years,
- •One or more lower work cramp attacks during/after dialysis
- •Have a constant dryness in the last 1 month (few changes weighing more than 2 kg)
- •Receiving at least 6 hemodialysis treatments
- •Receiving hemodialysis treatment 3 times a week
- •Those who have not received sub-massage therapy before
排除标准
- •Having one of the diagnoses of chronic obstructive pulmonary disease, cancer, psychiatric disease
- •Presence of any soft tissue, nerve and vascular disease in the lower extremities
- •Presence of infection, open wound, suspected fracture, dermatitis, burn and edema in the lower extremities
- •Having had a lower extremity operation in the past six weeks
- •Receiving hemodialysis treatment for less than 6 months (new patients are excluded because the first few months of dialysis treatment are periods of hemodynamic instability)
- •Having a fluctuating dry weight (excluded from the study as it may cause cramping)
- •Having been diagnosed with neuropathy in the lower extremities
结局指标
主要结局
Patient follow-up forms.
时间窗: during 2 weeks (15 days)
Intradialytic systolic and diastolic blood pressure and ultrafiltration were noted by the investigator, during the HD session
Visual Analog Scala (VAS)
时间窗: during 2 weeks (15 days)
This scale; There is a number value of "0 (no pain)" at the beginning and "10 (the most unbearable pain)" at the end. Participants marked the scale each time they experience a muscle cramp severity. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
Muscle cramp assessment short survey (duration and frequency of muscle cramps)
时间窗: during 2 weeks (15 days)
Participants noted the duration and number of muscle cramps they experienced. Baseline measurements; muscle cramp experienced at home and, during the dialysis session.
次要结局
- Pittsburgh Sleep Quality Index(PUKİ),(At the first and last meeting in 2 weeks (15 days))
研究者
Ayse Gul Parlak
Lecturer
Kafkas University