Effectiveness of Benson Relaxation Technique on Perceived Stress and Pain Among Hemodialysis Patients in an Urban Community Amman, Jordan: a Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- The change of Perceived Stress Level at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention.
研究概览
简要总结
This study aims to evaluate the effectiveness of Benson relaxation technique on perceived stress and pain among hemodialysis patients at governmental hospitals in Amman, Jordan. Half of the participants the intervention group will receive the intervention of Benson relaxation technique, while the other half the control group will receive a nutrition package session.
详细描述
This study aims to evaluate the effectiveness of Benson relaxation technique on perceived stress and pain among hemodialysis patients at governmental hospitals in Amman, Jordan at baseline, post-test, one and two months' follow-up assessment.
Two large governmental hospitals in Amman, Jordan will be randomly assigned in to experimental hospital (n=1) and control hospital (n=1). One hundred hemodialysis patients will be randomly assigned to experimental group (n = 50) and control group (n = 50). Intervention group will receive the Benson relaxation technique and the control group will receive a nutrition session. Measures of Perceived stress and pain using the Perceived stress scale (PSS) and the Short-Form McGill Pain Questionnaire (SF-MPQ) will be administered at pre-test, post-test, one and 2-months follow-up assessment. Data collection will be performed by two research assistance who are blind to treatment conditions.
Sample size:
The sample size for this study will be calculated to achieve a power of 0.80 with an alpha significance of 0.05 (2-tailed). The sample size for hemodialysis patients is based on a previous intervention study.
The following is sample size calculation formula:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blinding will be used in this study, by not telling the participants, interventionist, and research assistants what the researcher is looking for to study, what the research outcomes are, and by making them not aware who is receiving the intervention or in which group they are in control or intervention group. So, the participants, interventionist, and research assistants who are in the study will be less likely to inadvertently bias the result.
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
- •Hemodialysis patients who agree to participate in the study (by consent form).
- •Hemodialysis patients begin alert, conscious, and oriented.
- •Hemodialysis patients able to read and write in Arabic.
- •Haemodialysis patients aged 18 years and above, participants of this age and above are adults and able to understand the items in the questionnaires in order to be able to answer them.
- •Haemodialysis patients being on haemodialysis for at least six months and currently receiving haemodialysis at a minimum of two times per week. By 6 months, the routine for the hemodialysis procedure is established, and two times per week is the minimum number for dialysis sessions.
排除标准
- •Hemodialysis patients with physical disability and physical limitation for learning and performing the Benson relaxation technique.
- •Peritoneal dialysis or a kidney transplant patients.
- •Patients who are taking antidepressants medication.
- •Haemodialysis patients with cognitive impairment or mental health issues.
- •Hemodialysis patients that face crisis intervention including changes in disease progress or loss of consciousness.
- •Hemodialysis patients with emotional upheaval, such as death of a relative or a family member and divorce in their family, and those with any problems which had a negative impact on their mood during the previous month were excluded, The reason for these exclusions was that these complications might affect the concentration which is important in the relaxation technique and these patients might have difficulty in performing this procedure.
- •No co-morbidity with other chronic disease like cancer, heart disease, etc. Diabetes and hypertension are included, because usually these co-morbidities are a part of renal failure; excluding them leads to limitation in generalization.
结局指标
主要结局
The change of Perceived Stress Level at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention.
时间窗: at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention.
Perceived stress refers to an undesired state of feeling frustrated, anger and nervous of anxious, which is experienced by hemodialysis patients. The level of stress for the hemodialysis patients will be assessed using the Perceived Stress Scale. The perceived stress scale (PSS-10) has 10 items on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Four positively stated items (item 4, 5, 7, and 8) are reversely scored (0 = very often, 1 = fairy often, 2 = sometimes, 3 = almost never, 4 = never). The sum of the 10 items represents the total score, with higher scores representing higher levels of perceived stress. Individual scores on the Perceived stress score (PSS-10) can range from 0 to 40 with higher scores indicating higher perceived stress.
The change of Pain level at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention.
时间窗: at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention.
Pain is the feeling of unpleasant sensory and discomfort which is experienced by hemodialysis patients. Pain will be measured by scores on the short form McGill Pain Questionnaire (SF-MPQ). The short form McGill Pain Questionnaire (SF-MPQ) consists of three parts: * The first part: consists of 15 descriptive adjectives, 11 sensory and four affective, which are rated on a four point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), yielding three scores. * The second part: Visual Analogue Scale (VAS), which is a 10-centimeter horizontal line from 0 to 10 ranging from "no pain" to the "worst possible pain". * The third part: Present Pain Intensity (PPI), which is a six-point verbal rating scale on rating scale from 0 to 5, the words are: no pain (0), mild pain (1), discomforting (2), distressing (3), horrible (4), and excruciating (5).
次要结局
未报告次要终点
研究者
Haya Ibrahim Abu Maloh
PhD Nursing Student
Universiti Putra Malaysia