The Effects of Progressive Muscle Relaxation on Pain Intensity, Pain Catastrophizing, and Quality of Life in Patients With End Stage Renal Disease: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The Arabic Pain Catastrophizing Scale
研究概览
简要总结
Background: Patients with chronic end-stage renal disease (ESRD) commonly experience chronic pain, which significantly impair their quality of life. This pain is often exacerbated by maladaptive cognitive appraisals, in particular pain catastrophizing. This study investigated the effectiveness of progressive muscle relaxation (PMR) on pain intensity, pain catastrophizing, and health-related quality of life on patients undergoing with ESRD.
Methods: This randomized controlled parallel study was conducted in a governmental hospital in Jordan in 2024. Participants (N= 104) were randomly assigned to an experimental group offered five sessions of 30 minutes of PMR per week over a total period of five weeks and a control group, which receives standard treatment. The outcomes were measured by Arabic validated scales such as the Pain Catastrophizing Scale, Numerical Pain Rating Scale and the Renal Disease Quality of Life questionnaire at baseline and the end of the intervention.
详细描述
Patients with chronic end-stage renal disease (ESRD) commonly experience chronic pain, which significantly impair their quality of life. This pain is often exacerbated by maladaptive cognitive appraisals, in particular pain catastrophizing. This study investigated the effectiveness of progressive muscle relaxation (PMR) on pain intensity, pain catastrophizing, and health-related quality of life on patients undergoing with ESRD.
This study using a pretest-post-test randomized controlled parallel design was conducted in a Dialysis facility in a Government Military Hospitals. This facility is the biggest in the middle east that includes 58 dialysis machines and treats 2,200-2,240 patients monthly. The participants were chosen by a convenience sampling method and then randomly allocated into experimental and control groups. Research assistant who did not participate in any phase of the study (e.g. recruitment or measurement) performed the participants' allocation using a cluster random assignment method explained below.
The sample size was calculated using G*power 3.1.9.4. The estimated sample size was 102 given an independent t-test, a medium effect size of 0.5, an alpha of 0.05, and a power of 0.8. Considering a 15% attrition rate, 117 participants are needed for the sample. The final necessary sample size was 120 individuals after 3 persons were added to be more cautious. Out of the 170 individuals that had their eligibility evaluated, 120 were found to be eligible and consented to take part. 104 of them finished the study, and their data was analysed. Due to health concerns, the remaining 16 participants decided to leave the study prior to the collection of baseline data.
After getting the approval of the Institutional Research Board (IRB), the research investigator approached hospital management requesting them to allow the study to be carried out at their hospital. Upon consent, the researcher interviewed the subjects individually on their study objectives and processes. The informed consent statement was forwarded to all the participants who had agreed to participate in the research. The participants were then randomly assigned to the experimental group and the control group using a cluster random assignment to avoid contamination. To implement this assignment approach, a list of participants who met the criteria for the research was made, along with their shifts (A, B, and C). Participants received hemodialysis three times a week on either Sunday, Tuesday, and Thursday (STT) or Monday, Wednesday, and Saturday (MWS). The above arrangement resulted in six clusters: two shifts per week (STT or MWS) × three shifts per day (A, B, and C). The clusters (STT Shift A, 2) STT Shift B, 3) STT Shift C, 4) MWS Shift A, 5) MWS Shift B, and 6) MMWS Shift C were defined by a mixture of hemodialysis days and shifts. Listing all six clusters-each with twenty subjects according to the sample size calculation-was an initial procedure. Following that, these clusters were randomly assigned to the control or experimental groups. Randomizing participants was carried out using a random number generation technique to ensure an unbiased assignment. This random assignment method was used by an investigator who had no involvement in recruiting participants and was blind to the participant list.
After randomization, baseline assessments of the study sociodemographics and dependent variables were conducted in the hemodialysis unit before the intervention started. At the end of the intervention, which occurred five weeks following the actual MBI training, the study dependent variables were assessed again. A qualified research assistant collected the data without taking part in other study components. A qualified research assistant collected the data without taking part in other study components. This research assistant has a strong background in nephrology and is a registered nurse. Every measurement in the hemodialysis unit was conducted in private, with similar settings (e.g., temperature) and conditions (e.g., sitting position). There was nobody there when they finished the questionnaire.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with ESRD who had a smartphone
- •aged eighteen years or above
- •and received hemodialysis at least thrice a week
排除标准
- •The patients with ESRD patients who received psychotherapy
- •or took regular psychopharmacological and analgesic treatment
研究组 & 干预措施
Progressive Muscle Relaxation
This group received five weekly 30-minute sessions of Progressive Muscle Relaxation (PMR) based on the ABC relaxation theory. The PMR protocol developed by Smith (2005) involve tense-and-release exercises for 11 different muscle groups, including hands, arms, sides, back, shoulders, face, neck, stomach, chest, legs, and feet. For five to ten seconds, each muscle group is contracted, and for twenty to thirty seconds, it is relaxed. The sensations of stress and relaxation were the participants' main concern. To release any residual tension, they looked at each muscle group after the workout. With the exception of the time needed for measurements and instructions, the entire operation took roughly thirty minutes.
干预措施: Progressive Muscle Relaxation (Behavioral)
Waitlist Control Group
The control group received no intervention from the researcher during the study. However, following the intervention, the control group participants were given the audio recordings of the intervention protocol along with an explanation of them.
干预措施: Control Group (Other)
结局指标
主要结局
The Arabic Pain Catastrophizing Scale
时间窗: From enrollment to the end of treatment at 6 weeks
The Arabic Pain Catastrophizing Scale (PCS) was used to measure pain catastrophizing in the study. It consists of 13 items that evaluate an individual's thoughts and emotions connected to pain. Three aspects of pain catastrophizing are measured by PCS: helplessness (6 items) magnification (3 items) and rumination (4 items). Patients rate how often they experience the above thoughts and sensations when they are in pain. They use a 5-point Likert-type scale, ranging from 0 (not at all) 1 to 4 (all the time). By adding together, the scores for each question, one may get the subscale scores. These scores are between 0 to 52, with higher scores are indicative of a greater pain catastrophizing. A reliable and valid method for assessing catastrophizing in chronic pain patients who speak Arabic is the Arabic version of the Pain Catastrophizing Scale (PCS). The scale demonstrated strong internal consistency, with a Cronbach's α of 0.94.
Visual Analog Scale (VAS)
时间窗: From enrollment to the end of intervention at 6 weeks
The scale asks respondents to select the value (between 0 and 10) which most closely represents their level of pain. High test-retest reliability has been demonstrated by both literate and illiterate rheumatoid arthritis patients (r = 0.96 and 0.95, respectively). With correlation ranging from 0.86 to 0.95, the NPRS was found to have a strong association with the VAS for construct validity among individuals with chronic pain disorders (pain that lasts a minimum of six months). The scale has been found to be a valid and reliable tool for assessing pain severity in Arabic-speaking nations.
Arabic version of the kidney disease-related Quality of Life questionnaire
时间窗: From enrollment to the end of intervention at 6 weeks
Quality of life was assessed using the Arabic version of the kidney disease-related Quality of Life questionnaire (KDQOL-36). It comprises four subscales: generic core \[Physical Component Summary (PCS, 12 items) and mental component summary (MCS, 12 items); symptoms and issues (12 items); burden of renal disease (4 items); and impacts of kidney disease (8 items) (Elamin et al., 2019). The raw, pre-coded numerical values of each item are linearly transformed into a scale ranging from 0 to 100, where higher numbers denote a higher quality of life. Positive psychometric characteristics were found in Arabic patients with chronic renal insufficiency using the scale's Arabic version. With a Cronbach's alpha of 0.81, the KDQOL-36 translation demonstrated high internal reliability.
The Arabic Pain Catastrophizing Scale
时间窗: From enrollment to the end of treatment at 6 weeks
The Arabic Pain Catastrophizing Scale (PCS) was used to measure pain catastrophizing in the study. It consists of 13 items that evaluate an individual's thoughts and emotions connected to pain. Three aspects of pain catastrophizing are measured by PCS: helplessness (6 items) magnification (3 items) and rumination (4 items). Patients rate how often they experience the above thoughts and sensations when they are in pain. They use a 5-point Likert-type scale, ranging from 0 (not at all) 1 to 4 (all the time). By adding together, the scores for each question, one may get the subscale scores. These scores are between 0 to 52, with higher scores are indicative of a greater pain catastrophizing. A reliable and valid method for assessing catastrophizing in chronic pain patients who speak Arabic is the Arabic version of the Pain Catastrophizing Scale (PCS). The scale demonstrated strong internal consistency, with a Cronbach's α of 0.94.
Visual Analog Scale (VAS)
时间窗: From enrollment to the end of intervention at 6 weeks
The scale asks respondents to select the value (between 0 and 10) which most closely represents their level of pain. High test-retest reliability has been demonstrated by both literate and illiterate rheumatoid arthritis patients (r = 0.96 and 0.95, respectively). With correlation ranging from 0.86 to 0.95, the NPRS was found to have a strong association with the VAS for construct validity among individuals with chronic pain disorders (pain that lasts a minimum of six months). The scale has been found to be a valid and reliable tool for assessing pain severity in Arabic-speaking nations.
Arabic version of the kidney disease-related Quality of Life questionnaire
时间窗: From enrollment to the end of intervention at 6 weeks
Quality of life was assessed using the Arabic version of the kidney disease-related Quality of Life questionnaire (KDQOL-36). It comprises four subscales: generic core \[Physical Component Summary (PCS, 12 items) and mental component summary (MCS, 12 items); symptoms and issues (12 items); burden of renal disease (4 items); and impacts of kidney disease (8 items) (Elamin et al., 2019). The raw, pre-coded numerical values of each item are linearly transformed into a scale ranging from 0 to 100, where higher numbers denote a higher quality of life. Positive psychometric characteristics were found in Arabic patients with chronic renal insufficiency using the scale's Arabic version. With a Cronbach's alpha of 0.81, the KDQOL-36 translation demonstrated high internal reliability.
次要结局
未报告次要终点
研究者
Hossam Najjem Alhawatmeh
Associate Peofessor
Jordan University of Science and Technology