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Набор скоро начнётся NCT06625125

PMR vs MM for Patients on Hemodialysis

Без фазы С лечением End Stage Renal Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mindfulness-based intervention, Progressive muscle relaxation.
Кому может быть актуально
Состояния в реестре: End Stage Renal Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Иордания
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

There have been studies supporting the potential positive effects of MBI and PMR on perceived stress among patients undergoing hemodialysis. However, the mechanisms of the beneficial effects of both therapies such as MBI and PMR on perceived stress among such patients have been rarely studied. In recent years, there has been an increasing interest in identifying the underlying mechanisms of mind body therapies because of growing evidence of its benefits on mental disorders and physical well-being. A number of theoretical approaches have been suggested to identify how MBI or PMR affects perceived stress. It has been proposed that the mechanisms of open monitoring practice such as MBI potentially involve changes in emotion regulation strategies such as stress reappraisal. However, focused attention practice such as PMR can affect health through increased expression suppression as an emotional regulation strategy.

Reappraisal is an emotional regulation strategy that reduces emotional responses through a change of the meaning of a certain stressful situation. Thus, it has a long-term effect on perceived stress. Expressive suppression, However, is an emotional regulation strategy that inhibits behaviors related to emotional responses (e.g., facial expressions) and decrease the emotions' expression, not their experience. Notably, reappraisal has been emphasized as one of the mechanisms through which MBI works. However, expression may be one of the mechanisms through which PMR works. Expressive suppression opposes important aspect of mindfulness, described as the awareness and acceptance of emotions, but matches with the avoidance coping, which has lower effect on perceived stress and its effects on stress are short-lived. Accordingly, mindfulness has been reported to be positively related to cognitive reappraisal and negatively with expressive suppression.

It is explained that psychosomatic health problems such as perceived stress result from the conditioned automatic cycle of association formed from distressing thoughts and associated feelings and sensations that is initiated when attention is not consciously or intentionally directed. For example, when one experiences a certain threat (alarming thought), emotion (e.g. fair) is evoked that is accompanied by physical sensations (e. g. muscle tension). Our habitual reactions to feelings or sensations are to pursue those that are evaluated as pleasant and to avoid those that are evaluated unpleasant. These habitual reactions are expressed as mental events or thoughts that rapidly follow the initial alarming thought, feeling and sensation. The mental events or thoughts that follow the initial thought, feeling, and sensation also have associated feelings and sensations. This associational cycle is maintained as long as attention remains preoccupied with or embedded in these components in an unconscious way that, in turn, leads to chronically elevated psychosomatic stress responses. In OM meditation, practitioner who intentionally pays attention to sensations, emotions, and thoughts moment- to- moment will become aware of that these experiences are transitory that arise and pass away and do not constitute lasing entity and there is no need take steps to avoid them. The effect of this state of nonreactive awareness on stress responses is mediated by the emotional regulation strategy of cognitive reappraisal. Cognitive reappraisal is defined as re-evaluating the meaning of a distressed stimulus to change the negative emotional responses. In short, being aware of that the emotions, sensations and thoughts are transitory, and not-lasting objects that arise and pass away cultivate the belief that these experiences are passing events that does not endanger health if people do not habitually avoid or be over-engaged with them (cognitive reappraisal).

FA practice such as PMR can lead to positive outcomes related to psychosomatic health, however, it works through mechanisms that are different from the mechanisms employed in OM meditation. The effect of FA meditation on stress responses is mediated by the emotion regulation strategy of thought suppression, not cognitive reappraisal as Lutz et al. explained. Expressive suppression is defined as intentionally removing a distress thought or behavior from conscious awareness. Attentional resources are limited, which means that attention can be paid to only one object at a time. Thus, if attention is sufficiently sustained on an object such as sensations of breath or muscular tension and relaxation, this prevents practitioner to remain preoccupied with or aware of other objects in that moment such as distressed thoughts and in turn decrease stress responses. FA meditation does not lead to cognitive reappraisal. In FA meditation, practitioner tries to not evaluate or be judgmental about the distractor (stimulus) and in turn creates a temporary state of "non-appraisal", not reappraisal. This state of non-appraisal resulting from the inhibition thought, or behaviors is temporary that ends when attention lapses from the meditation object (e.g. muscle tension and relaxation), unlike the cognitive reappraisal evoked by OM meditation, which have long-lasting effect on perceived stress.

To the best of our knowledge, however, these theoretical approaches that explain the differential mechanism and effect of open monitoring practice (e.g. MBI) and focused attention practice (e.g. PMR) on perceived stress have been rarely empirically supported., especially in patients with ESRD. Thus, the purpose of this study is to compare the differential effects of MBI and PMR on cognitive reappraisal, expressive suppression, and perceived stress in patients with ESRD undergoing hemodialysis.

Methods

Design and Setting

An experimental study with a randomized, repeated-measures, parallel control design will be conducted in hemodialysis units in two Jordanian hospitals- King Abdullah University Hospital and the Prince Rashid Military Hospital.

Participants

The G\*Power (3.1 software's) analysis suggested that a sample size of 159 participants will be adequate to study as per an analysis of variance (ANOVA), given a Cronbach's alpha (α) level of significance of .05, a power level of 0.8, and a moderate effect size of 0.25.

Interventions

The MBI and PMR groups will receive MBI and PMR respectively according to Smith's (2005) protocols. It is standardized theory-based interventions found to be effective in improving physical and psychological health outcomes. The subjects in both groups will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks (e.g. PMR group will receive PMR protocol, but MBI will receive MBI protocol). This approach has been used and found to be feasible and effective for patients receiving hemodialysis. Subjects in both groups will receive audio recording of their assigned intervention developed by the principal investigator (PI) according to the Smith's MBI protocol that will provide intervention instructions. The assigned audio recording will be sent to the subjects via WhatsApp (iOS and Android) to be used during the intervention sessions, to warrant the consistent delivery of the intervention. To ensure that they can practice effectively, they will be supervised by a study researcher during the intervention sessions. During the eight weeks and at bedtime at night, the subjects will be optionally encouraged to practice the intervention at home.

Before the beginning of the self-administered intervention sessions, face-to face foundation Course (2 hours) will be conducted by the certified study researcher who educated and trained the subjects on their assigned interventions in separate rooms about the basics and protocol of their intervention. The certified study researcher who had an advanced degree in nursing and 12 years of nursing experience received an extensive training workshop on "Mind-Body Practice". A checklist will be developed and maintained by the PI including all steps of the intervention (each step and the length of time to spend on each step) to achieve high degrees of adherence. The subjects were requested not to take any psychotherapies or psychopharmacological medications if they are necessarily needed, and to notify the PI of such treatments were taken during the intervention. Patients' medical records were checked regularly during the intervention to warrant they did not receive any psychological and analgesic medication. Any potential interruption (e.g., the dialysis machine alarm) was handled instantly by the attending nurses.

MBI

The mindful mediators are asked to act as neutral observers who quietly attend to, notice, and let go of internal and external stimuli (present experiences) such as thoughts, feelings, physical sensations, and sounds without reactions, evaluation, and judgments. They are asked not to make any attempts to think about or push away these stimuli. They ea

Вмешательства

  • Поведенческое Mindfulness-based intervention
    The mindful mediators are asked to act as neutral observers who quietly attend to, notice, and let go of internal and external stimuli (present experiences) such as thoughts, feelings, physical sensations, and sounds without reactions, evaluation, and judgments. (Smith, 2005). The subjects in the mindfulness-based intervention (MBI) group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks (Al
  • Поведенческое Progressive muscle relaxation
    he progressive muscle relaxation (PMR) group will receive the ABC version of PMR (Smith, 2005). This abbreviated version of PMR involves a tense-let go exercise of 11 muscle groups including hand, arm, arm and sides, back, shoulder, face, front of neck, stomach, chest, leg, and foot. As the MBI group, the subjects in the PMR group will receive 30 minutes individually administered, guided, chairside interventions during their hemodialysis sessions, three times a week over eight weeks. Subjects i

Первичные конечные точки

  • Perceived Stress Scale (PSS) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
  • Emotion Regulation Questionnaire (ERQ) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
Вторичные конечные точки (1)
  • The Mindful Attention Awareness Scale (MAAS) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Patients under psychotherapy or taking regular psychopharmacological and analgesic treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Иордания · 1 центр
  • Prince Rashid Military Hospital — Irbid

Публикации

  • Alhawatmeh H, Alshammari S, Rababah JA. Effects of mindfulness meditation on trait mindfulness, perceived stress, emotion regulation, and quality of life in hemodialysis patients: A randomized controlled trial. Int J Nurs Sci. 2022 Mar 8;9(2):139-146. doi: 10.1016/j.ijnss.2022.03.004. eCollection 2022 Apr. PMID 35509694
  • Almadi T, Cathers I, Hamdan Mansour AM, Chow CM. An Arabic version of the perceived stress scale: translation and validation study. Int J Nurs Stud. 2012 Jan;49(1):84-9. doi: 10.1016/j.ijnurstu.2011.07.012. Epub 2011 Aug 17. PMID 21851941
  • Beevers, C. G., Wenzlaff, R. M., Hayes, A. M., & Scott, W. D. (1999). Depression and the ironic effects of thought suppression: Therapeutic strategies for improving mental control. Clinical Psychology: Science and Practice, 6,133-148
  • Bennett PN, Ngo T, Kalife C, Schiller B. Improving wellbeing in patients undergoing dialysis: Can meditation help? Semin Dial. 2018 Jan;31(1):59-64. doi: 10.1111/sdi.12656. Epub 2017 Nov 2. PMID 29098724
  • Carmody, J. (2009). Evolving conceptions of mindfulness in clinical settings. Journal of Cognitive Psychotherapy, 23, 270-280.
  • Chambers R, Gullone E, Allen NB. Mindful emotion regulation: An integrative review. Clin Psychol Rev. 2009 Aug;29(6):560-72. doi: 10.1016/j.cpr.2009.06.005. Epub 2009 Jun 23. PMID 19632752
  • Chu SWF, Yeam CT, Low LL, Tay WY, Foo WYM, Seng JJB. The role of mind-body interventions in pre-dialysis chronic kidney disease and dialysis patients - A systematic review of literature. Complement Ther Med. 2021 Mar;57:102652. doi: 10.1016/j.ctim.2020.102652. Epub 2020 Dec 26. PMID 33373760
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. PMID 6668417

Идентификаторы

NCT: NCT06625125 · 2024/369

Первоисточники (государственные реестры)

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