Response Of Arteriovenous Fistula Puncture-related Pain To Cryotherapy Application In Haemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Visual analogue scale (VAS):
研究概览
简要总结
Kidney disease occurs when kidney reduces its normal function, less than 30% of normal activity is related to a long-term condition. Therefore, people need to participate in a haemodialysis (HD) programme. In HD, blood is filtered by an external machine, done about three times a week and the access is gained through intermittent vascular cannulation.
The patients experience considerable pain due to the frequent insertion of AVF catheters.
Hemodialysis patients experience anxiety before needle insertion due to repeated punctures, and over 90% of patients experience acute pain during the process.
Puncture-related pain during arteriovenous fistula (AVF) cannulation in particular is a crucial influential factor in quality of life.
Cryotherapy is one of the interventions used in several studies to alleviate the arteriovenous fistula puncture-related pain. It can be conduct by using ice packs and the results of the previous studies have also shown its positive effects on the relief of the fistula puncture-related pain in these patients.
详细描述
Ninety male and female patients with end stage renal disease randomly assigned into three equal groups (n=30) their ages ranged between 30-50:
- Group A (30 patients) receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis.
- Group B (30 patients) receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis.
- Group C (30 patients) it is a control group this group not received ice pack.
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
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study includes patients with ages from 30 to 50 years.
- •Patients able to report pain adequately.
- •Patients with end-stage kidney failure undergoing regular hemodialysis who have been treated for more than 3 months, at least twice per week, with arteriovenous fistula in use for more than 1 month are included in the study.
排除标准
- •Patients with conditions such as
- •advanced age,
- •advanced diabetes,
- •cardiovascular insufficiency,
- •cold allergy,
- •Reynaud's phenomenon,
- •nerve and tissue damage,
- •fractures,
- •heart failure,
- •uncooperative patients,
- •cognitive impairment preventing a proper assessment of pain.
结局指标
主要结局
Visual analogue scale (VAS):
时间窗: Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions
Scale to measure the intensity of pain The minimum value is 0 which means no pain and the maximum value is 10 which means the maximum pain
次要结局
- Hospital Anxiety and Depression Scale (HADS):(Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.)
- The Arm Motor Ability Test (AMAT)(The Arm Motor Ability Test (AMAT): it is measured at baseline, and it will be measured again immediately after 20 sessions.)
研究者
Sara Fathy Mohamed Elsaid
Physical therapist
Cairo University