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临床试验/NCT06622200
NCT06622200尚未招募不适用

The Effects of Mindfulness-based Intervention on Trait Mindfulness, Cognitive Reappraisal, Behavioral Suppression, and Quality of Life Among Patients Undergoing Hemodialysis.

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
2
主要终点
kidney Disease- related Quality of Life questionnaire

研究概览

简要总结

The study aims to investigate how mindfulness-based intervention (MBI) impacts trait mindfulness, cognitive reappraisal, expressive suppression and quality of life in patients with end-stage renal disease (ESRD) undergoing hemodialysis.

A Randomized controlled trial will be conducted with patients diagnosed with ESRD and undergoing hemodialysis treatment. Participants selected using a convenience sampling method will be randomly assigned into the intervention group (n=52) who received MBI, and the control group (n=52) who received a similar intervention after the study. The intervention involves a 30-minute MBI introduced three sessions per week during hemodialysis sessions over five weeks. Outcome measures included the Mindful Attention Awareness Scale (MAAS) to assess trait mindfulness, the Emotion Regulation Questionnaire (ERQ) for cognitive reappraisal and behavioral suppression, and the Kidney Disease-related Quality of Life Questionnaire for quality of life. Data were collected at baseline and post-intervention.

详细描述

Chronic kidney disease (CKD) is a comprehensive term encompassing various stages of diminishing kidney function. Kidney damage or sustained estimated glomerular filtration rate (eGFR) of less than 60 ml/min per 1.73 square meters sustained for three months or more are hallmarks of chronic kidney disease (CKD). Individuals affected by CKD commonly encounter symptoms such as fatigue, headaches, weakness, nausea, vomiting swelling in the legs and feet occurs frequently. Challenges in concentration also manifest. If left untreated, CKD can lead to serious complications such as fluid retention high blood pressure, anemia bone disease. Effective management of CKD, such as regular monitoring, lifestyle changes, medication, and other medical interventions remains pivotal in mitigating its progression and associated complications. Left unaddressed, CKD has the potential to advance to end-stage renal disease (ESRD). This necessitates life-saving interventions like dialysis or kidney transplantation (Khusainova et al., 2023; Vaidya & Aeddula, 2023).

ESRD has emerged as a leading global cause of death, standing out as one of the few non-communicable diseases with a rising mortality rate over the past two decades. Over 800 million people worldwide suffer from ESRD, a degenerative illness that affects more than 10% of the population (Kovesdy, 2022). In the United States, ESRD exhibits an incidence rate of 390.2 cases per million and a prevalence rate of 242 cases per million. Black and Hispanic patients had rates of ESRD that were 3.4 and 1.5 times higher, respectively, then those of the general population. Individuals aged 65 and older are at the highest risk of developing ESRD, accounting for about three-quarters of all cases (Johansen et al., 2021).

The prevalence of chronic kidney disease (CKD) is highest in low- and middle-income nations, where controlling its effects is difficult (Kovesdy, 2022). In Jordan, the Jordanian Ministry of Health (MOH) (2020) states that the total number of patients who were registered and treated in the Jordanian Renal Registry will be 7747 by the end of 2020, of which 7290 are Jordanians (94. 1%) and 457 are non-Jordanians (5.9%). The number of Jordanian patients enrolled and hospitalized for ESRD in 2020 was 7290, while the number of new ESRD cases in 2020 was 975, with 898 (92.1%) Jordanians and 77 (7. 9%) non-Jordanians (Jordanian Ministry of Health, 2020).

Renal replacement therapies become necessary when kidneys can no longer perform essential functions ensuring that waste products and excess fluid are removed from the body adequately (Vaidya & Aeddula, 2023). Among renal replacement therapies, hemodialysis is a key therapy that extends life by excreting or removing harmful waste products of metabolism from the circulatory system of humans. Of patients with ESRD, hemodialysis accounts for 70.7% of treatment, with kidney transplantation accounting for 29.3% of cases in the United States (Johansen et al., 2021). In Jordan, the total number of dialysis machines (944) in all units was distributed as follows: 441 (47%) machines in Ministry of Health units, 86 (9%) machines in Royal Medical Service (RMS) units, 32 (3%) machines in university hospitals, and 385 (41%) machines in private sector hospitals. Of the 7290 patients with prevalent ESRD, 3318 patients (45.5%) were treated in dialysis units of the Ministry of Health, 1424 patients (19.5%) in RMS dialysis units, 191 patients (2.6%) in dialysis unit of the University Hospital, and 2,357 patients (32.3%) were treated in private dialysis units.

Despite its role in extending the lives of patients with ESRD, research indicates that individuals undergoing hemodialysis experience a lower quality of life (QOL) compared to those with other chronic illnesses (Dehghan et al., 2020). QOL is a widely recognized concept that reflects an individual's perception of their physical health, psychological well-being, independence, social relationships, beliefs, and personal values (Madadkar & Basiri, 2018). Patients with ESRD undergoing hemodialysis face numerous physical symptoms that limit their daily functioning and threaten their overall physical health. Also, the treatment itself is physically and mentally demanding, as patients typically receive hemodialysis 2 to 3 times per week for 4 to 5 hours per session, which significantly impacts their psychosocial well-being. The combined effects of the illness and the treatment create a substantial burden, jeopardizing the overall QOL for those undergoing hemodialysis (Lim & Lee, 2022).

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 (Investigator)

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

  • Patients with ESRD undergoing hemodialysis at least three sessions a week
  • Being at least 18 years old
  • Having a smartphone
  • Being capable of reading and writing in Arabic

排除标准

  • Patients under psychotherapy or taking regular psychopharmacological and analgesic treatment

结局指标

主要结局

kidney Disease- related Quality of Life questionnaire

时间窗: From enrollment to the end of treatment at 6 weeks

The Arabic version of the kidney disease- related Quality of Life questionnaire (KDQOL-36) was used to evaluate quality of life. It has four subscales: symptoms and problems (12 items); burden of kidney disease (4 items); effects of kidney disease (8 items); and generic core \[Physical Component Summary (PCS, 12 items) and mental component summary (MCS, 12 items) (Elamin et al., 2019). Each item\'s raw, pre-coded numerical values are converted linearly to a scale from 0 to 100, where higher numbers indicate better quality of life (Kalantar-Zadeh \& Unruh, 2005). The Arabic version of the scale revealed favorable psychometric attributes in Arabic patients with chronic renal insufficiency and The KDQOL-36 translation showed a Cronbach\'s alpha of 0.81, demonstrating strong internal reliability (Alhawatmeh et al., 2022; Elamin et al., 2019).

次要结局

  • Emotional Regulation Questionnaire(From enrollment to the end of treatment at 6 weeks)
  • Mindful Attention Awareness Scale(From enrollment to the end of treatment at 6 weeks)

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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