Меню
Набор скоро начнётся NCT06622200

The Effect of Mindfulness on Emotional Regulations Skills and Quality of Life Among Patients on Hemodialysis

Без фазы С лечением End-Stage Kidney 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.
Кому может быть актуально
Состояния в реестре: End-Stage Kidney 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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).

Patients on hemodialysis who experience a decline in QOL may experience effects on many aspects of their lives, including a diminished capacity to do daily tasks (Madadkar \& Baser, 2018). Furthermore, poor QOL contributes to dependency, sadness, social isolation, a reduction in daily activities, and a rise in the financial burden (Dehghan et al., 2020). The work, familial, and social status of individuals with ESRD also altered because of changes in their quality of life (Adamopoulou et al., 2019; Nguyen et al., 2022) Hence, effectively managing diminished QOL and addressing its underlying symptomatic causes are crucial for enhancing clinical outcomes in individuals undergoing hemodialysis. Both pharmacological and non-pharmacological approaches are employed to address these issues. However, a significant number of patients continue to experience psychosomatic symptoms even with the utilization of medications. Presently, there is a growing focus on integrating non-pharmacological and complementary therapies within healthcare systems for improved outcomes (Madadkar \& Basiri, 2018). Methods in complementary medicine typically carry minimal side effects and risks, making them suitable for standalone use or in conjunction with other approaches (Kaplan Serin et al., 2020). These therapies, known for their holistic nature, are employed to enhance both the physical and mental well-being of patients (Nguyen et al., 2022).

Mindfulness-based intervention (MBI) is a common and effective complementary therapy that has widespread use in a variety of contexts, groups, and applications (Howarth et al., 2019). MBI teaches people how to cultivate a non-judgmental awareness that is oriented toward the present moment. This intervention has shown potential for treating a number of mental health conditions, including anxiety and depression, as well as persistent physical illnesses (Rigas et al., 2022). In hemodialysis settings, MBI has been found to be effective in improving multiple psychosomatic symptoms such as perceived stress, emotion regulation, sleep disturbances, stress, depression, and anxiety in patients with ESRD worldwide (Razzera et al., 2021). Also, there is initial evidence in the literature supporting the beneficial effect of MBI on quality of life in such patients (Alhawatmeh et al., 2022).

There have been several studies supporting the potential positive effects of MBI on psychophysical health and overall QOL among patients undergoing hemodialysis. However, the mechanisms underlying the beneficial effects of MBI on health among such patients have been rarely studied. In recent years, there has been an increasing interest in identifying the underlying mechanisms of MBI because of growing evidence of its benefits on mental disorders and physical well-being (Gu \& Zhu, 2022; Zhang et al., 2021). Several theoretical approaches have been suggested to identify how MBI affects quality of life.

The mechanisms of MBIs have been hypothesized to involve improvements in trait mindfulness, which then facilitate gains in emotion regulation skills, thereby culminating in improved quality of life outcomes (Niazi \& Adil, 2017; Shapero et al., 2018; Teper \& Inzlicht, 2013; Zhang et al., 2021). T. Indeed, this view is supported by evidence from several studies (Niazi \& Adil, 2017; Shapero et al., 2018; Teper \& Inzlicht, 2013; Zhang et al., 2021). In the context of the above-outlined framework, the major two strategies for emotion regulation that are mostly studied include cognitive reappraisal and behavioral suppression. Research showed that MBIs enhance cognitive reappraisal, described as reinterpretation of stressful situations in a positive way to lower emotional distress. Evidence on the effectiveness of MBI in behavioral suppression, understood as the suppression of emotional expressions, remains scant and ambiguous. Though findings might be mixed, some studies do indicate a possible positive influence of MBI on cognitive reappraisal, but when it comes to behavior suppression, their effect is negligible or non-significant. This may be related to the fact that the basic mechanism of MBI tends to improve trait mindfulness through present-moment awareness and acceptance rather than suppression of emotions.

Despite these advances, evidence is still developing, and more research needs to be done in order to understand how MBI relate to disparate strategies for regulating emotions. Importantly, such processes have not as yet been investigated empirically in hemodialysis patients-a population experiencing emotional burdens and low quality of life. To the best of our knowledge, no study has yet systematically investigated how MBI would affect emotion regulation processes, namely cognitive reappraisal and expressive suppression, in this patient population. Furthermore, the wider effects of MBI on trait mindfulness and quality of life among hemodialysis patients remain largely unaddressed. The present study therefore tried to fill these gaps in knowledge by assessing the impacts that MBI have on trait mindfulness, cognitive reappraisal, and expressive suppression in hemodialysis patients. It further aimed to explore the impact of MBI on quality of life, thereby offering insight into possible therapeutic benefits that may be gained from the practice of MBI in this highly specific clinical setting.

Methodology

Design An experimental study with a pretest-posttest, randomized, parallel control group design was employed. Participants who were selected using a convenience sampling method were randomly assigned into the intervention group who received MBI, and the control group who received the similar intervention after the study. The intervention involved 30-minute MBI introduced three sessions per week during hemodialysis sessions over a five-week period. The study data were collected at baseline and the end of the intervention.

Setting and Sample This study was conducted at a military hospital Military in the dialysis department, which contains 58 dialysis machines. In this department, there are three sessions per day throughout the week, with three dialysis sessions for each patient per week. The dialyis department receives approximately 174 patients daily, divided into three sessions throughout the day. This dialysis department is considered as the largest dialysis unit in the Middle East, with a monthly capacity of between 2,200 and 2,240 patients (Shqeirat et al., 2021).

Determination of Sample Size G\*power 3.1.9.4 was used to calculate the sample size. Given an independent t-test, a medium effect size of 0.5, an alpha of 0.05, and a power of 0.8, the calculated sample size was 102. Taking in consideration an attrition rate of 15 % (Alhawatmeh et al., 2022), the required sample size is 117 participants. To be more conservative, 3 participants were added, resulting in a final required sample size of 120 participants. Of the 170 assessed for eligibility, 120 participants were deemed eligible and agreed to participate. Of these, 104 completed the study and their data were analyzed. The remaining 16 participants chose to withdraw from the study before baseline data collection due to health issues (See Figure 1).

Intervention In the present research, the standardized, theory based MBI was introduced to the experimental group (Smith, 2005). Th

Вмешательства

  • Поведенческое Mindfulness-based Intervention
    In the present research, the standardized, theory based MBI was introduced to the experimental group (Smith, 2005). This 30-minute protocol involves a series of activities, including paying attention to and being aware of breath, body sensations, thoughts, and sounds without judgment. This protocol is a widely recognized and utilized method due to its simplicity and accessibility, making it an ideal choice for this study. Participants in the experimental group completed three weekly sessions of

Первичные конечные точки

  • kidney Disease- related Quality of Life questionnaire [Срок оценки: From enrollment to the end of treatment at 6 weeks]
Вторичные конечные точки (2)
  • Emotional Regulation Questionnaire [Срок оценки: From enrollment to the end of treatment at 6 weeks]
  • Mindful Attention Awareness Scale [Срок оценки: From enrollment to the end of treatment at 6 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

  • Adamoli, A. N., Razzera, B. N., Ranheiri, M. F., Colferai, R. N., Russell, T. A., Noto, A. R., & da Silva de Oliveira, M. (2021). Mindfulness-Based Intervention Performed During Hemodialysis: An Experience Report. Trends in Psychology, 29(2), 320-340. https://doi.org/10.1007/s43076-020-00058-8.
  • Adamopoulou F, Alikari V, Zyga S, Tsironi M, Tzavella F, Giannakopoulou N, Theofilou P. The Effect of Fatigue and Pain Self- Efficacy on Health-Related Quality of Life Among Patients with Multiple Sclerosis. Mater Sociomed. 2019 Mar;31(1):40-44. doi: 10.5455/msm.2019.31.40-44. PMID 31213954
  • 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
  • Alhawatmeh HN, Rababa M, Alfaqih M, Albataineh R, Hweidi I, Abu Awwad A. The Benefits of Mindfulness Meditation on Trait Mindfulness, Perceived Stress, Cortisol, and C-Reactive Protein in Nursing Students: A Randomized Controlled Trial. Adv Med Educ Pract. 2022 Jan 13;13:47-58. doi: 10.2147/AMEP.S348062. eCollection 2022. PMID 35046747
  • Alhawatmeh H, Najadat IA, Hweidi IM. Mindfulness-based intervention as a symptom management strategy in patients with end-stage renal disease: A controlled clinical trial. Int J Nurs Pract. 2024 Dec;30(6):e13282. doi: 10.1111/ijn.13282. Epub 2024 Jun 16. PMID 38880954
  • Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822. PMID 12703651
  • Dehghan M, Namjoo Z, Bahrami A, Tajedini H, Shamsaddini-Lori Z, Zarei A, Dehghani M, Ranjbar MS, Rafiee Sarbijan Nasab F. The use of complementary and alternative medicines, and quality of life in patients under hemodialysis: A survey in southeast Iran. Complement Ther Med. 2020 Jun;51:102431. doi: 10.1016/j.ctim.2020.102431. Epub 2020 May 21. PMID 32507442
  • Desrosiers A, Vine V, Klemanski DH, Nolen-Hoeksema S. Mindfulness and emotion regulation in depression and anxiety: common and distinct mechanisms of action. Depress Anxiety. 2013 Jul;30(7):654-61. doi: 10.1002/da.22124. Epub 2013 Apr 16. PMID 23592556

Идентификаторы

NCT: NCT06622200 · 136-2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗