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AzTrials

Chronic Kidney Disease (Stage 3-4)MPSANCT07837206

Impact of Mindfulness on Pain In SA

A study testing Mindfulness-Based Intervention in people with Chronic Kidney Disease (Stage 3-4), run by Jordan University of Science and Technology at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease (Stage 3-4)
What is being tested?
Mindfulness-Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSaudi Arabia
Study dates
7 Jan 2025to 1 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Dr. Sulima Fakeeh Hospital

    Jeddah, Mecca Region, 23717

Other trials in Saudi Arabia

About this study

Official 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

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.

Being tested
Mindfulness-Based Intervention
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based InterventionBehavioural

    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)

Study groups in NCT07837206
Study groupRoleWhat they receive
Patients on Hemodialysis receiving Mindfulness-based InterventionExperimentalPatients 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)
Receives: Behavioral: Mindfulness-Based Intervention
Control GroupNo interventionThe control group was treated with the conventional hemodialysis nursing care without any mindfulness-related audio materials and content.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Catastrophizing Scale (PCS)

    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)

    Measured: From enrollment to the end of intervention at 5 weeks

  2. Numeric Rating Scale (NRS)

    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).

    Measured: From enrollment to the end of intervention at 5 weeks

  3. Kidney Disease Quality of Life- Short Form

    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).

    Measured: From enrollment to the end of intervention at 5 weeks

  4. Mindful Attention Awareness Scale

    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).

    Measured: From enrollment to the end of intervention at 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2026
  2. Study start7 Jan 2025
  3. Primary completion30 Nov 2025
  4. Study completion1 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07837206
Sponsor's protocol ID
FIRB-25-0060
Acronym
MPSA
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhu M, Wong SY, Zhong CC, Zeng Y, Xie L, Lee EK, Chung VC, Sit RW. Which type and dosage of mindfulness-based interventions are most effective for chronic pain? A systematic review and network meta-analysis. J Psychosom Res. 2025 Apr;191:112061. doi: 10.1016/j.jpsychores.2025.112061. Epub 2025 Feb 10.

    PubMed 40010103

  • Zhang Q, Ma Y, Dai Z, Wang Q, Yin W, Liu S, Li J. Pain Catastrophizing: Mechanisms and Clinical Implications. J Pain Res. 2026 May 18;19:592713. doi: 10.2147/JPR.S592713. eCollection 2026.

    PubMed 42183039

  • Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28.

    PubMed 26818413

  • Terkawi AS, Sullivan M, Abolkhair A, Al-Zhahrani T, Terkawi RS, Alasfar EM, Khait SSA, Elkabbani A, Kabbani N, Altirkawi KA, Tsang S. Development and validation of Arabic version of the pain catastrophizing scale. Saudi J Anaesth. 2017 May;11(Suppl 1):S63-S70. doi: 10.4103/sja.SJA_130_17.

    PubMed 28616005

  • Tawhari M, Alhamadh M, Alhabeeb A, Ureeg A, Alghnam S, Alhejaili F, Alnasser LA, Sayyari A. Establishing the Kidney dIsease in the National guarD (KIND) registry: an opportunity for epidemiological and clinical research in Saudi Arabia. BMC Nephrol. 2024 Feb 19;25(1):59. doi: 10.1186/s12882-024-03479-0.

    PubMed 38374104

  • Shen X, Li H, Sun F, Gu M, Zhang H, Zhu F. A Mobile-Based Mindfulness Intervention for Reducing Demoralization in Patients on Maintenance Hemodialysis: Randomized Controlled Trial. J Med Internet Res. 2026 Aug 7;28:e90324. doi: 10.2196/90324.

    PubMed 42566776

  • Razzera BN, Adamoli AN, Ranheiri MF, Oliveira MDS, Feoli AMP. Impacts of mindfulness-based interventions in people undergoing hemodialysis: a systematic review. J Bras Nefrol. 2022 Jan-Mar;44(1):84-96. doi: 10.1590/2175-8239-JBN-2021-0116.

    PubMed 34643641

  • Rayan A, Ahmad M. The psychometric properties of the mindful attention awareness scale among Arab parents of children with autism spectrum disorder. Arch Psychiatr Nurs. 2018 Jun;32(3):444-448. doi: 10.1016/j.apnu.2018.01.001. Epub 2018 Jan 3.

    PubMed 29784228

  • Ploesser M, Martin D. Mechanism of Action of Mindfulness-Based Interventions for Pain Relief-A Systematic Review. J Integr Complement Med. 2024 Dec;30(12):1162-1178. doi: 10.1089/jicm.2023.0328. Epub 2024 Jul 23.

    PubMed 39042592

  • Murwani, W. G., Fahrun Nur Rosyid, & Dian Hudiyawati. (2026). Effect of intradialytic mindfulness-based meditation on spiritual well-being and anxiety in hemodialysis patients: a randomized controlled trial. MEDISAINS: Jurnal Ilmiah Ilmu-Ilmu Kesehatan, 24(1), 48-52. https://doi.org/10.30595/medisains.v24i1.28905

  • Haugmark T, Hagen KB, Smedslund G, Zangi HA. Mindfulness- and acceptance-based interventions for patients with fibromyalgia - A systematic review and meta-analyses. PLoS One. 2019 Sep 3;14(9):e0221897. doi: 10.1371/journal.pone.0221897. eCollection 2019.

    PubMed 31479478

  • Grunberg VA, Mace RA, Bannon SM, Greenberg J, Bakhshaie J, Vranceanu AM. Mechanisms of change in depression and anxiety within a mind-body activity intervention for chronic pain. J Affect Disord. 2021 Sep 1;292:534-541. doi: 10.1016/j.jad.2021.05.069. Epub 2021 Jun 5.

    PubMed 34147965

  • Fan C, Wu M, Liu H, Chen X, Gao Z, Zhao X, Zhou J, Jiang Z. Effects of meditation on neural responses to pain: A systematic review and meta-analysis of fMRI studies. Neurosci Biobehav Rev. 2024 Jul;162:105735. doi: 10.1016/j.neubiorev.2024.105735. Epub 2024 May 29.

    PubMed 38821153

  • Elamin S, E Elbasher AH, E Ali SE, Abu-Aisha H. Arabic translation, adaptation, and validation of the kidney disease quality of life short-form 36. Saudi J Kidney Dis Transpl. 2019 Nov-Dec;30(6):1322-1332. doi: 10.4103/1319-2442.275476.

    PubMed 31929279

  • 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.

    PubMed 12703651

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Intervention in people with Chronic Kidney Disease (Stage 3-4), run by Jordan University of Science and Technology at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Catastrophizing Scale (PCS) (time frame: From enrollment to the end of intervention at 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07837206, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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