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Completed

NCT Number: NCT07837206

Impact of Mindfulness on Pain In SA

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being 18 years or older
  • Receiving maintenance hemodialysis for at least six months
  • being able to communicate in Arabic
  • Having smart phone

Exclusion criteria

  • Having severe cognitive impairment or clinically significant psychiatric illness
  • concurrent enrollment in another structured psychological program

Treatment and study plan

Mindfulness-based Intervention

Behavioral

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)

Primary outcomes

  1. Pain Catastrophizing Scale (PCS)

    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)

  2. Numeric Rating Scale (NRS)

    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).

  3. Kidney Disease Quality of Life- Short Form

    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).

  4. Mindful Attention Awareness Scale

    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).

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Collaborators

  • Fakeeh College for Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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