TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION VERSUS DISTRACTIVE TECHNIQUES ON ARTERIOVENOUS FISTULA PUNCTURE PAIN IN HEMODIALYSIS PATIENTS
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The KDQOL-36, Numerical Rating Scale for pain measurement
研究概览
简要总结
Statement of the problem:
This study will be conducted to answer the following question:
Is there a difference in the efficacy of TENS and distractive techniques when combined with cryotherapy in managing pain due to arteriovenous fistula puncture and improving quality of life in hemodialysis patients ?
Null Hypotheses:
- TENS has no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
- Distractive techniques have no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
- There is no statistically significant difference between TENS and distractive techniques in managing pain and improving quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
详细描述
Subjects' Selection:
The patients will be randomly assigned to 3 groups;
- Group (1) will receive (TENS , cryotherapy and conventional physical therapy program).
- Group (2) will receive (distractive techniques , cryotherapy and conventional physical therapy program).
- Group (3) will receive (cryotherapy and conventional physical therapy program). Patients will be assessed for quality of life before and after treatment and will receive 3 sessions per week consisted of TENS, distractive techniques , Cryotherapy and conventional physical therapy program during AVF Puncture during dialysis for 4 weeks.
1-Inclusion criteria:
- Patient age will range from 20 - 60 years who have chronic renal failure from males and females.
- At least one year passed from the installation of AVF and hemodialysis.
- Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours.
- Having no traces of skin abnormalities or analgesia in vessels access point.
2-Exclusion Criteria:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-Inclusion criteria:
- •Patient age will range from 20 - 60 years who have chronic renal failure from males and females.
- •At least one year passed from the installation of AVF and hemodialysis.
- •Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours.
- •Having no traces of skin abnormalities or analgesia in vessels access point.
排除标准
- •2-Exclusion Criteria:
- •The following were considered exclusion criteria:
- •Unwillingness to continue with the study.
- •Unsuccessful AVF cannulation at the first try.
- •Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation.
- •Presence of infection and obstruction of fistula based on the nurse's inspection.
- •The presence of auditory and visual disturbances.
- •history of verbal disturbances; no addiction or drug dependence to pain medications; no history of mental health diseases; being conscious, having not taken painkillers, narcotics or sedatives at least six hours before hemodialysis.
- •Having traces of severe pain in other parts.
- •Having pacemakers
结局指标
主要结局
The KDQOL-36, Numerical Rating Scale for pain measurement
时间窗: one hour for each participant
1. Numerical Rating Scale of Pain Severity is numbered between 0 and 10 indicating positive and negative pain statements, respectively. Accordingly, the rating of this scale was 0 (lack of pain), 1-3 (low pain), 4-6 (moderate pain), 7-9 (severe pain), and 10 (very severe pain). The Cronbach's alpha coefficient for this tool was reported as 0.95 and its reliability score using the intra-class correlation coefficient was 0.92 (Mirtajadini et al., 2016). 2. The KDQOL-36: It is a 36-item health-related quality of life instrument adapted from the original 134-item KDQOL, an instrument principally developed to measure quality of life of dialysis patients \[25\].
次要结局
未报告次要终点
研究者
Gamal Abdelmohsen Abdelhakim Hassan
physical therapist
Cairo University