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临床试验/NCT07837206
NCT07837206已完成不适用

Effects of a Mindfulness-Based Intervention on Pain Severity, Pain Catastrophizing, Quality of Life, and Trait Mindfulness in Patients Undergoing Hemodialysis in Saudi Arabia

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Pain Catastrophizing Scale (PCS)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Control Group

No Intervention

The control group was treated with the conventional hemodialysis nursing care without any mindfulness-related audio materials and content.

Patients on Hemodialysis receiving Mindfulness-based Intervention

Experimental

Patients on hemodialysis received mindfulness-based intervention which 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 (smith, 2005)

干预措施: Mindfulness-Based Intervention (Behavioral)

结局指标

主要结局

Pain Catastrophizing Scale (PCS)

时间窗: 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)

Numeric Rating Scale (NRS)

时间窗: 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).

Kidney Disease Quality of Life- Short Form

时间窗: 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).

Mindful Attention Awareness Scale

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Najjem Alhawatmeh

Associate professor

Jordan University of Science and Technology

研究点 (1)

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