About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients under psychotherapy or taking regular psychopharmacological and analgesic treatment
Trial design
Parallel
Treatments tested in this trial
Mindfulness-based Intervention
BehavioralIn 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 MBI for five weeks during their hemodialysis treatments (Alhawatmeh et al., 2022). Participants were provided with audio recordings of the MBI protocol, which they could practice during hemodialysis sessions. These recordings were delivered via email and WhatsApp, depending on their preference. This audio recording was developed based on the Smith's protocol by a certified study researcher who had a higher degree in nursing and extensive experience in practicing and delivering MBIs.
Treatment groups
Trial outcomes
Primary outcomes
kidney Disease- related Quality of Life questionnaire
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).
Secondary outcomes
Emotional Regulation Questionnaire
The Arabic version of the Emotion Regulation Questionnaire (ERQ) developed by Keshky (2018) was used to assess cognitive reappraisal and expressive suppression. The scale consists of 10 items, each rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). The scale consists of two subscales measuring two emotion regulation abilities: expressive suppression (4 items) and cognitive reappraisal (6 items). The higher scores indicate greater emotion regulation abilities (Gross \& John, 2003). The Arabic version showed valid and reliable results among Arabic Gulf population and patients undergoing hemodialysis with the Cronbach alpha of the study instrument is 0.83 (Alhawatmeh et al., 2022; Keshky, 2018).
Mindful Attention Awareness Scale
The Mindful Attention Awareness Scale (MAAS) is a widely used self-report measure designed to assess an individual\'s trait mindfulness-their general capacity to be present and attentive to ongoing experiences in daily life. The MAAS typically consists of 15 items. Patients rate how frequently they experience various characteristics of mindfulness in day-to-day activities. Participants rate each item on a Likert-type scale. This scale indicates frequency of experiences from \"1: almost always\" to \"5: almost never\" (Brown \& Ryan, 2003). Score ranges from 15 to 75. Higher scores reflect a greater tendency to be mindful and present in daily life. Strong convergent validity and internal consistency are demonstrated by Arabic MAAS among Arab hemodialysis patients (Alhawatmeh et al., 2022).
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