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临床试验/NCT06625125
NCT06625125尚未招募不适用

The Differential Effects of Mindfulness-Based Intervention and Progressive Muscle Relaxation on Expression Suppression, Cognitive Reappraisal, and Perceived Stress in Patients With End-Stage Renal Disease: A Randomized Trial

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 159 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
159
试验地点
2
主要终点
Perceived Stress Scale (PSS)

研究概览

简要总结

Background: Hemodialysis is considered as an effective therapy to remove harmful waste from the body and to improve the quality of life in patients suffering from end-stage renal disease (ESRD). However, patients who receive hemodialysis perceive various stressors that are harmful to their physical and psychological well-being. Therefore, it is necessary to implement effective and practical therapeutic strategies to enhance the quality of life in this population. Mindfulness-based intervention (MBI) and progressive muscle relaxation (PMR) are effective mind-body connection programs that are inadequately used in patients undergoing hemodialysis.

Objectives: This study will examine the differential effects of mindfulness-based intervention (MBI) and progressive muscle relaxation (PMR) on expression suppression, cognitive reappraisal, and perceived Stress in Patients with End-Stage Renal Disease undergoing hemodialysis in Jordan.

Methods: An experimental parallel control, randomized design will be implemented among 159 PwESRD undergoing hemodialysis in a big referral Hospital in Jordan. Simple random assignation will be used to create three equal groups including PMR, MBI, and control groups (N= each). Both groups will practice their assigned intervention over five weeks (with three half-hour sessions per week) during hemodialysis sessions. The study variables will be measured for the three groups at the outset and eight weeks after initiation. Variables will be measured by the self-reporting questionnaire including sociodemographic characteristic sheet, the Mindfulness attention awareness scale (MAAS) the Perceived Stress Scale (PSS), and the Emotion Regulation Questionnaire (ERQ). Repeated measures analysis of variance (RM ANOVA) will be used to analyze the main study data.

详细描述

Background

End-stage renal disease (ESRD) is a serious health issue that affects 10-14% of the adult population worldwide. ESRD, which has become one of the top causes of death on a global scale, is characterized by the kidneys only operating at 10 to 15% of their normal capacity. In Jordan, according to its registry of renal patients, the Ministry of Health (MoH) reported 7747 of such patients by the beginning of 2021, comprising 7290 Jordanian nationals (94.1%), and 457 (5.9%) non-Jordanians.

Hemodialysis (HD) is a vitally important treatment for patients with ESRD (PwESRD), that extends life by excreting the body's toxic metabolic waste. However, the difficulties that patients on HD confront are various and significant, putting such patients under sever level of perceived stress. HD is one of the most stressful treatments because it has so many stressors, including the requirement to visit medical facilities, to stay a significant amount of time there, to take prescribed medications, to manage diet and fluid intake, and to seriously alter lifestyle choices and possibilities. Although acute stress works to maintain bodily hemostasis, repeated exposures to stress over time can negatively affect patients' physical, psychological and social health, jeopardizing their quality of life.

Globally, the use of complementary and alternative medicine (CAM) has grown over the past 20 years. Mind-body interventions are a core part of CAM. Mind body interventions is described by the National Center for Complementary and Integrative Health as a collection of practices or techniques that primarily concentrate on the relationships between the mind, body, and behavior and how those relationships affect one's stress and quality of life. It includes practices like music therapy, yoga, hypnosis, meditation including mindfulness, and relaxation. Mindfulness-based intervention (MBI) and progressive muscle relaxation (PMR) are the most well-established and widely used complementary therapies.

MBI is defined as moment-by-moment awareness of daily experiences with the attitudes of acceptance and non-judgment. PMR is defined as the act of regular and systematic tensing and relaxing different muscle groups with focused attention on relaxation and tension of these muscles. These Mind-body therapies, recently increasing their popularity in Jordan, are easily accessible, easy to learn and inexpensive. Mind-body interventions were classified as focused attention practice and open monitoring practice, which have differential treatment mechanisms and effects. Focused attention practices involve sustaining attention to a single stimulus such as tension and relaxation of muscles. However, open monitoring practices involve a receptive awareness or monitoring of all stimuli that arise moment-to-moment. Accordingly, MBI can be classified as an open monitoring (OM) practice while PMR classified as a focused attention (FA) practice.

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

The outcome assessor will be blinded to the participants' random assignment to either the experimental or control group.

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

Perceived Stress Scale (PSS)

时间窗: From enrollment to the end of treatment at 8 weeks

An Arabic version of the Perceived Stress Scale (PSS) was used to measure the degree to which situations in one's life are appraised as stressful (unpredictable, uncontrollable, and overloaded) (Almadi, et al., 2012). It includes 10 items measured on a 5-point Likert scale (0=never, 4= very often), which are relatively free of content specific to any subpopulation group. The scores range from 0 to 40 with higher score indicating higher levels of perceived stress (stressful appraisal) (Cohen, et al., 1983). PSS has been validated for use with college students. Internal consistency coefficients for the PSS ranged from .84 to 36, and test- retest reliability is .85 (Cohen et al., 1983). The Arabic Perceived Stress Scale showed adequate reliability and validity and considered a suitable instrument to assess perceived stress in Arabic people (Almadi et al., 2012).

Emotion Regulation Questionnaire (ERQ)

时间窗: From enrollment to the end of treatment at 8 weeks

An Arabic version of ERQ will be used to measure emotion regulation abilities including cognitive reappraisal and expression suppression. The questionnaire is a 7-point Likert-type scale, with two subscales including cognitive reappraisal (6 items) and expressive suppression (4 items). The scale items are rated on a scale from 1 (strongly disagree) to 7 (strongly agree). The higher scores indicate greater emotion regulation abilities such as cognitive reappraisal and expressive suppression (Gross \& John, 2003). Arabic version showed valid and reliable results among Arabic Gulf population and Jordanian patients with ESRD (Alhawatmeh et al. 2022; Keshky, 2018).

次要结局

  • The Mindful Attention Awareness Scale (MAAS)(From enrollment to the end of treatment at 8 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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