The Role of Using Elastic Compression Stockings in the Prevention of Muscles Cramps Episode in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Cramp Questionnaire Chart
研究概览
简要总结
the Objectives of this clinical trial is :
- examine the effect of using elastic compression stockings in the prevention of muscle cramps among hemodialysis patients.
- Find out the difference between the effect of compression stockings in the prevention of muscle cramps with patients' sociodemographic and clinical data.
详细描述
Intradialytic muscles cramps are frequent complication, and common cause of early hemodialysis (HD) termination. These cramps are thought to be precipitated by intradialytic venous stasis and reduced tissue perfusion. Elastic compression stockings (ECS), compress the calf and thigh to counteract venous pooling, and increase venous return.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who are at least eighteen years old.
- •Both genders (male & female).
- •Patients who are conscious and cooperative.
- •Patients experiencing muscle cramps during previous hemodialysis session.
- •Patients who would like to participate in part in the study .
- •Patients with verbally communicated skills.
排除标准
- •Irregular hemodialysis treatment
- •Presence of femoral catheters
- •Any lower limb pathology or musculoskeletal impairments
- •Patients undergoing emergency or first-time hemodialysis
- •Pilot study participants.
- •Patients decline to take part in the trial.
- •Patients who are unable to tolerate the exercises and compression stockings .
研究组 & 干预措施
control group
Patients in the control group received their usual medical care during hemodialysis without any additional interventions.
compression stockings group
Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the hemodialysis session. This was performed once per day for a single hemodialysis session.
干预措施: compression stockings (Device)
结局指标
主要结局
Cramp Questionnaire Chart
时间窗: Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
The instrument was developed by Morris (2014), and permission was obtained from the author. It was used in the study to assess patients' muscle cramps. This scale is composed of five features of muscle cramps: frequency, duration, pain level, leg temperature, and discomfort. These features are comprehensively scored as a level of muscle cramps ranging from 0 to 13.
Visual analogue scale (VAS) for pain
时间窗: Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session
The Visual Analogue Scale (VAS) is a validated, subjective scale for acute and chronic pain. It was initially introduced by Hayes and Patterson in 1921. Scoring involved self-reported symptom scales that are scored with a single handwritten mark placed at a single point along a 10 cm line representing continuity between the two ends of the scale - "no pain" at the left end (0 cm) of the scale and "worst pain" at the right end of the scale (10 cm).
Cramp Questionnaire Chart
时间窗: The intensity of muscular cramps was recorded before the hemodialysis session began and immediately at the end of the hemodialysis session.
The instrument was developed by Morris (2014) to assess muscle cramps level. permission was obtained from the author It was translated into Arabic version by an two English-Arabic language specialist. It was used in the study to assess patients' muscle cramps level pre and post exercises and compression stockings application. This scale is composed of five features of muscle cramps: frequency, duration, pain level, leg temperature and discomfort. which was comprehensively scored as a level of muscle cramps ranging from (0-13).
Visual analogue scale (VAS) for pain
时间窗: The Visual analogue scale (VAS) for pain was recorded before the hemodialysis session began and immediately at the end of the hemodialysis session.
The Visual Analogue Scale (VAS) is a validated, subjective scale for acute and chronic pain. It was initially introduced by Hayes and Patterson in 1921. Scoring involved self-reported symptom scales that are scored with a single handwritten mark placed at a single point along a 10 cm line representing continuity between the two ends of the scale - "no pain" at the left end (0 cm) of the scale and "worst pain" at the right end of the scale (10 cm).
次要结局
未报告次要终点
研究者
Zahraa Adel Kareem
Master's graduate student
Karbala University