Dr. Sulima Fakeeh Hospital
Jeddah, Mecca Region, 23717, Saudi Arabia
NCT Number: NCT07837206
Background: Patients with end-stage renal disease (ESRD) undergoing hemodialysis often experience chronic pain, maladaptive pain cognitions, and diminished quality of life, yet evidence on mindfulness-based interventions (MBIs) in Middle Eastern dialysis populations remains limited. Objective: This trial evaluated the effectiveness of a five-week mindfulness meditation program on pain severity, pain catastrophizing, quality of life, and trait mindfulness in hemodialysis patients.
Methods: A randomized controlled trial with a pre-post design was conducted with 38 adults on maintenance hemodialysis at Dr. Soliman Fakeeh Hospital, Jeddah (19 intervention, 19 control). The intervention group received 30-minute mindfulness meditation sessions three times weekly during dialysis for five weeks; the control group received standard care. Outcomes were assessed at baseline and post-intervention using the Numeric Rating Scale (NRS), the Pain Catastrophizing Scale (PCS), the Kidney Disease Quality of Life Short Form (KDQOL-36), and the Mindful Attention Awareness Scale (MAAS). A 2×2 mixed-design analysis of variance (ANOVA) compared change over time within and between groups.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Jeddah, Mecca Region, 23717, Saudi Arabia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention consisted of a five-week, self-administered, audio-guided mindfulness meditation program delivered via a pre-recorded audio file uploaded onto each participant's personal mobile phone. Participants in the intervention group were asked to listen to the recording for 30 minutes, three times weekly, for five weeks (15 sessions total), timed to coincide with their scheduled hemodialysis sessions so that listening took place while the participant was already seated and connected to the dialysis equipment. The recording followed a standardized sequence: (a) a brief orientation to the session's focus, (b) guided focused-attention breathing, (c) a body-scan exercise adapted to the seated, immobile positioning required during dialysis, and (d) a period of open, non-judgmental awareness of present-moment thoughts, sensations, and emotions. The audio recording was developed by a certified mindfulness practitioner and based on the mindfulness-based protocol (Smith, 2005)
Time frame: From enrollment to the end of intervention at 5 weeks
Pain catastrophizing was measured using the 13-item Pain Catastrophizing Scale (PCS; Sullivan et al., 1995), administered in its Arabic-validated form (Terkawi et al., 2017). Each item is rated on a 5-point scale (0 = not at all to 4 = all the time) and summed to produce a total score ranging from 0 to 52, together with three subscale scores reflecting rumination, magnification, and helplessness. Higher scores indicate a greater tendency to catastrophize about pain-that is, more rumination, exaggerated appraisal of pain-related threat, and feelings of helplessness-while lower scores indicate a more adaptive, less distressed cognitive response to pain; a total score of 30 or above is commonly used in the pain literature as an indicator of clinically significant catastrophizing. The original PCS demonstrated strong internal consistency (α = .87) and good construct and criterion validity against measures of pain-related distress and disability (Sullivan et al., 1995)
Time frame: From enrollment to the end of intervention at 5 weeks
Pain severity was measured using the Numeric Rating Scale (NRS), an 11-point self-report scale on which participants indicate the number, from 0 to 10, that best reflects their pain intensity at the time of assessment (Jensen et al., 1986; Scott & Huskisson, 1976). A score of 0 represents "no pain" and a score of 10 represents "the worst pain imaginable"; scores are conventionally grouped into mild (1-3), moderate (4-6), and severe (7-10) pain. The NRS has demonstrated strong concurrent validity with the Visual Analogue Scale and good test-retest reliability across chronic and acute pain populations, and its simple response format makes it well suited to patients with fatigue or reduced dexterity during dialysis (Jensen et al., 1986).
Time frame: From enrollment to the end of intervention at 5 weeks
Quality of life was measured using the Kidney Disease Quality of Life Short Form (KDQOL-36), a 36-item, kidney-disease-specific instrument that combines the generic SF-12 physical and mental health composite scores with three kidney-specific subscales: symptoms/problems of kidney disease, effects of kidney disease on daily life, and burden of kidney disease. Each subscale and composite is transformed to a 0-100 metric, with higher scores indicating better perceived quality of life and a lower symptom or disease burden, and lower scores indicating poorer functioning and greater burden. The instrument has well-established reliability and validity in hemodialysis populations internationally, with subscale Cronbach's alpha values generally exceeding .70, and the Arabic version used in this study has demonstrated comparable internal consistency (α = .72-.92) and construct validity in Arabic-speaking dialysis samples (Elamin et al., 2019; Alhawatmeh et al., 2022).
Time frame: From enrollment to the end of intervention at 5 weeks
Trait, or dispositional, mindfulness was measured using the 15-item Mindful Attention Awareness Scale (Brown & Ryan, 2003), which asks respondents to rate the frequency of everyday experiences of inattention and reduced present-moment awareness on a 6-point scale (1 = almost always to 6 = almost never). Scores are summed across the 15 items, yielding a total ranging from 15 to 90, with higher scores indicating a greater disposition toward sustained, present-moment attention and awareness in daily life, and lower scores indicating more frequent mind-wandering, automatic behavior, and inattentiveness. The original MAAS demonstrated strong internal consistency (α = .82) and good convergent and discriminant validity against measures of well-being and emotional distress (Brown & Ryan, 2003), and the Arabic version used with Arabic samples, including dialysis populations, has shown similarly acceptable to strong reliability and validity (Alhawatmeh et al., 2022).
Jordan University of Science and Technology
Other
Effects of a Mindfulness-Based Intervention on Pain Severity, Pain Catastrophizing, Quality of Life, and Trait Mindfulness in Patients Undergoing Hemodialysis in Saudi Arabia
Acronym: MPSA
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