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临床试验/NCT06064994
NCT06064994已完成不适用

The Impact Of Mindfulness Meditation On Pain, Quality Of Sleep, Self-Esteem In Patients With End-Stage Renal Disease Undergoing Hemodialysis In Jordan

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Pain perception

研究概览

简要总结

Background: Hemodialysis affects patients' lives and is associated with social, occupational, psychological, and societal problems. Mind-body interventions (MBIs), like mindfulness meditation, have been gaining popularity in the health sector. Pain, sleep quality, and self-esteem have all been positively impacted by MBIs in patients with end-stage renal disease (ESRD). Health care providers may be able to provide more thorough care if they are aware of these interventions.

Purpose: To assess the impact of mindfulness meditation on pain, quality of sleep, and self-esteem, and self-management in patients with ESRD undergoing hemodialysis in Jordan.

Methods: An experimental repeated measure, randomized, parallel control design was conducted on 60 patients with ESRD undergoing hemodialysis between March and June 2023 in the dialysis center at Alkarak governmental hospital, Jordan. Participants were randomly assigned to the experimental (N =30) and control groups (N =30) using a simple random assignment method. The experimental group practiced mindfulness meditation for 30 minutes three times per week for five weeks during their hemodialysis treatments. The control group's patients continued to receive hemodialysis treatment as usual, with three hemodialysis sessions for five weeks without any additional intervention. The study variables for both groups were measured at baseline (T0), two weeks after intervention (T1), and at the end of intervention (T2). Variables were measured by the Numeric Pain Rating Scale (NPRS), the Pittsburgh Sleep Quality Index (PSQI), and the Rosenberg Self-Esteem Scale (RSES-M) questionnaire. Descriptive statistics like frequency, mean, and standard deviation were used to describe participants. The repeated measures ANOVA (within-subject) tests were used to examine the study hypotheses.

详细描述

Problem Statement

Despite the improvements in nursing management and the creation of new facilities, the gold standard treatments for patients with ESRD have not been firmly established (Wen et al., 2021). A significant number of stressors that hemodialysis patients suffer go unsolved during their dialysis treatments (Shinde & Mane, 2014). These stressors, both physical and mental, have a negative impact on physical and psychological health (Jeong & Park, 2012). For this population, how to cope with stressors matters because it can lead to increased morbidity or even earlier death.

Pain and poor sleep quality are highly prevalent among ESRD patients receiving hemodialysis. It has been found that approximately 94.6% and 89.23% of them had poor sleep quality and pain, respectively (Darvishi et al., 2019). Poor Sleep quality and pain among these patients impair not only quality of life, but also immune function. Further, they are even considered risk factors for many other chronic illnesses, significantly increasing morbidity and mortality (Alradaydeh & Khalil, 2019) . Low self-esteem is a major problem in ESRD patients receiving hemodialysis. Low self-esteem has been found to decreases adherence to treatment and self-care behaviors, worsening sleep quality and pain among these patients (Poorgholami et al., 2016).

Mind-body interventions have been employed in other chronic disorders like cancer, irritable bowel syndrome, and coronary heart disease much more than in renal disease (Bennett et al., 2017). Recently, studies that address mind-body interventions, such as relaxation therapy, might exist, but there have been limited studies to investigate the impact of mindfulness meditation. For example, there were studies addressing the effects of the Benson relaxation technique on pain and quality of life in patients on hemodialysis (Rambod et al., 2014). So, those researchers recommended that more research is needed to identify the impacts of mindfulness meditation on pain, quality of sleep, and self-esteem. So, the purpose of this study is to assess the impacts of mindfulness meditation on the mentioned variables among patients undergoing hemodialysis in Jordan.

Significance of the study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

A research assistant, who was not involved in any other aspects of the study and was blinded to the randomized allocation, measured the study variables at three points of time

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ESRD patient receiving hemodialysis three times per week,
  • being at least 18 years old,
  • being able to read and write Arabic.

排除标准

  • Patients with cognitive dysfunction or mental retardation,
  • those who regularly used psychopharmacological, pain or sleeping pills,
  • or received psychotherapy

结局指标

主要结局

Pain perception

时间窗: 6 weeks

The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain severity in adults (Child et al.,2005).The NPRS is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses a number (0-10 integers) that best describes the degree of pain (Rodriguez, 2001). Both literate and illiterate rheumatoid arthritis patients have shown high test-retest reliability (r = 0.96 and 0.95, respectively). For evaluating pain levels in Arabic countries, the Arabic Numeric Pain Rating Scale was a valid and reliable tool.The Arabic Numerical Pain Rating Scale had a high correlation coefficient (r140.93-0.94) with the VAS and VRS, indicating strong consistency in pain level measures among the three pain scales (Alghadir, Anwer, \& Iqbal, 2016).

Self-esteem

时间窗: 6 weeks

self-esteem was measured by the Rosenberg self-esteem scale (Rosenberg, 1989). Total score range from 10-40, highest score reveals better self-esteem (Rosenberg, 1979). The Arabic version of the RSES is valid, reliable, and beneficial to use among the Arab community, according to two studies conducted among the Arab population in Jordan and Lebanon (Bezri et al., 2022).

Quality of sleep

时间窗: 6 weeks

quality of sleep was measured by The Pittsburgh Sleep Quality Index (PSQI) (Buysse, Reynolds, Monk, Berman, and Kupfer, 1989). The PSQI was created to assess the clinical population's sleep quality. Subjective sleep quality (1 item), sleep latency (2 items), sleep duration (1 item), habitual sleep efficiency (3 items), sleep disturbances (9 items), use of sleeping medication (1 item), and daytime dysfunction (2) are the seven dimensions of sleep characteristics included in the PSQI. The scoring of PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Najjem Alhawatmeh

Associate professor

Jordan University of Science and Technology

研究点 (2)

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