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AzTrials

HemodialysisMSHPNCT07816354

Mindfulness for Saudi Hemodialysis Patients

A study testing Mindfulness-Based Intervention in people with Hemodialysis and End Stage Chronic Renal Failure, 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

This study aims to evaluate whether an MBI improves sleep quality, emotional symptoms (depression, anxiety, stress), emotion regulation, and trait mindfulness among adults with ESRD on HD. A randomized two-arm pre-post design was conducted with N = 38 patients at Dr. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemodialysis, End Stage Chronic Renal Failure
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
1 Jan 2025to 30 Aug 2025
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 aged 18 or above
  • having a history of maintenance dialysis for three months
  • having the capacity to self-report

Who cannot join

  • Having acute psychiatric illness or substantial cognitive dysfunction
  • Involving in frequent meditation or yoga practice.

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: The Effect of Mindfulness_Based Intervention on Sleep Quality, Emotional Symptoms, and Emotion Regulation Among Saudi Patients Receiving Hemodialysis

This study aims to evaluate whether an MBI improves sleep quality, emotional symptoms (depression, anxiety, stress), emotion regulation, and trait mindfulness among adults with ESRD on HD. A randomized two-arm pre-post design was conducted with N = 38 patients at Dr. Soliman Fakeeh Hospital (DSFH), Saudi Arabia (n = 19 intervention; n = 19 control). The intervention comprised 30-minute guided sessions, 3 times a week for 5 weeks during HD sessions. The control group received the study intervention after the study. Outcomes were assessed at baseline and post-intervention using the Pittsburgh Sleep Quality Index (PSQI), Depression Anxiety Stress Scale-21 (DASS-21), Emotion Regulation Questionnaire (ERQ), and Mindful Attention Awareness Scale (MAAS).

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 was a structured audio-based MBI program over a five-week period during regular hemodialysis procedure. The program, delivered using validated audio recordings, drew on the principles of mindfulness-based stress reduction (MBSR) and was tailored to the needs of hemodialysis patients . The intervention group participated in daily 30-minute sessions of guided MBI three times a week for five weeks. These sessions took place during the dialysis sessions to improve the feasibility and avoid placing further burdens on participants. The mindfulness intervention involved a number of key elements, such as focusing on the breathing, body scanning, awareness of the present moment and nonreactive monitoring of thoughts and feelings. Participants were advised to become mindful of their thoughts, feelings, and sensations, without trying to change them. The program also taught acceptance-based approaches and cognitive diffusion from negative thought

Study groups in NCT07816354
Study groupRoleWhat they receive
Mindfulness-based InterventionExperimentalThe intervention was a structured audio-based MBI program over a five-week period during regular hemodialysis procedure. The program, delivered using validated audio recordings, drew on the principles of mindfulness-based stress reduction (MBSR) and was tailored to the needs of hemodialysis patients. The intervention group participated in daily 30-minute sessions of guided MBI three times a week for five weeks. These sessions took place during the dialysis sessions to improve the feasibility and avoid placing further burdens on participants. The mindfulness intervention involved a number of key elements, such as focusing on the breathing, body scanning, awareness of the present moment and nonreactive monitoring of thoughts and feelings. Participants were advised to become mindful of their thoughts, feelings, and sensations, without trying to change them. The program also taught acceptance-based approaches and cognitive diffusion from negative thoughts.
Receives: Behavioral: Mindfulness-Based Intervention
Control GroupNo interventionThe control arm participants received no additional psychological or behavioural intervention during the trial

What is being measured

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

  1. Pittsburgh Sleep Quality Index

    It is used to gain a broad understanding of sleep architecture over the previous 30 days. This 19-item self-report questionnaire assesses seven components of sleep: sleep quality; sleep latency (time to fall asleep); sleep duration; sleep efficiency (time asleep, relative to total time in bed); sleep disturbances; use of sleeping medication; and daytime dysfunction (Buysse et al., 1989). The score for each component ranges from 0 to 3. Added together, the scores of the seven components produce a Global Sleep Quality Score, ranging from 0 to 21.

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

  2. Depression, Anxiety, and Stress Scale (DASS-21)

    The DASS-21 was used to assess the psychological distress of having end-stage renal disease. This scale includes three 7-item subscales that distinguish between the key elements of depression (e.g., dysphoria, hopelessness), anxiety (e.g., autonomic arousal, skeletal muscle effects) and stress (e.g., irritability, impatience). Respondents are asked to respond on a 4-point Likert scale according to how they have felt in the last week. As a shortened form of the original 42-item DASS, the scores of each of the three DASS-21 subscales are doubled to reflect ratings for the standard severity levels (from "Normal" to "Extremely Severe")

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

Secondary outcomes (2)

  1. The Emotion Regulation Questionnaire (ERQ)

    The ERQ assesses how participants regulate their emotions in response to the stressful situation of living with chronic illness. This 10-item questionnaire assesses two distinct strategies of emotion regulation, including cognitive reappraisal (6 items) and expressive suppression ( 4 items). Cognitive Reappraisal is an antecedent-focused strategy that involves changing the way one thinks about a stressful situation in order to modify its emotional effect (e.g., "When I am feeling down, I change the way I think about the situation to improve the way I feel"). Expressive Suppression is a response-focused strategy by which individuals control their emotions by suppressing their expression (e.g., "I keep my emotions to myself"). Responses are scored from 1 to 7 (1 = I strongly disagree, 7 = I strongly agree). Generally, higher reappraisal scores are associated with better mental health, and higher suppression scores with greater mental distress.

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

  2. Mindful Attention Awareness Scale (MAAS)

    The MAAS is used to measure "trait mindfulness" - the tendency to be aware of present-moment experiences in a nonjudgmental, nonreactive way. It This 15-item questionnaire measures the trait-like presence or absence of attention to current moment experiences rather than religious or meditative practices. Respondents rate items (e.g., "I find myself doing things without paying attention") on a 6-point scale (1 = almost always to 6 = almost never). A higher mean score indicates higher trait mindfulness.

    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 posted11 Sep 2026
  2. Study start1 Jan 2025
  3. Primary completion1 Aug 2025
  4. Study completion30 Aug 2025

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
NCT07816354
Sponsor's protocol ID
25-0055
Acronym
MSHP
Status last verified
Sep 2026
First submitted
7 Sep 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Smith, J. C. 2005. Relaxation, Meditation, & Mindfulness: A Mental Health Practitioner's Guide to New and Traditional Approaches. Springer Publishing Company

  • Rusch HL, Rosario M, Levison LM, Olivera A, Livingston WS, Wu T, Gill JM. The effect of mindfulness meditation on sleep quality: a systematic review and meta-analysis of randomized controlled trials. Ann N Y Acad Sci. 2019 Jun;1445(1):5-16. doi: 10.1111/nyas.13996. Epub 2018 Dec 21.

    PubMed 30575050

  • Rigas, G., Kallergis, E. M., & Manios, E. (2022). Mindfulness-based interventions and psychological outcomes in chronic illness: A meta-analysis. Health Psychology Review, 16(3), 456-472. https://doi.org/10.1080/17437199.2021.1872375

  • 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

  • Nassim M, Park H, Dikaios E, Potes A, Elbaz S, Mc Veigh C, Lipman M, Novak M, Trinh E, Alam A, Suri RS, Thomas Z, Torres-Platas S, Vasudev A, Sasi N, Gautier M, Mucsi I, Noble H, Rej S. Brief Mindfulness Intervention vs. Health Enhancement Program for Patients Undergoing Dialysis: A Randomized Controlled Trial. Healthcare (Basel). 2021 Jun 1;9(6):659. doi: 10.3390/healthcare9060659.

    PubMed 34205915

  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PubMed 7726811

  • Keshky, M. E. E. (2018). Factor Structure, Reliability and Validity of the Arabic version of the Emotion Regulation Questionnaire (ERQ) in a sample of Saudi children and adolescents. International Journal of Psychology and Behavioral Sciences, 8(2), 22-30.

  • Igarashi NS, Karam CH, Afonso RF, Carneiro FD, Lacerda SS, Santos BF, Kozasa EH, Rangel EB. The effects of a short-term meditation-based mindfulness protocol in patients receiving hemodialysis. Psychol Health Med. 2022 Jul;27(6):1286-1295. doi: 10.1080/13548506.2021.1871769. Epub 2021 Jan 15.

    PubMed 33449820

  • Handayani, W., Yetti, K., Masfuri, M., & Yona, S. (2025). Application of mind-body therapies on anxiety and quality of life in patients undergoing hemodialysis: A systematic review. Malahayati International Journal of Nursing and Health Science, 8(1), 1-13.

  • Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

    PubMed 12916575

  • Gross JJ. Antecedent- and response-focused emotion regulation: divergent consequences for experience, expression, and physiology. J Pers Soc Psychol. 1998 Jan;74(1):224-37. doi: 10.1037//0022-3514.74.1.224.

    PubMed 9457784

  • Garland EL, Hanley AW, Goldin PR, Gross JJ. Testing the mindfulness-to-meaning theory: Evidence for mindful positive emotion regulation from a reanalysis of longitudinal data. PLoS One. 2017 Dec 6;12(12):e0187727. doi: 10.1371/journal.pone.0187727. eCollection 2017.

    PubMed 29211754

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • 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 Hemodialysis and End Stage Chronic Renal Failure, 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 3 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 11 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?

Pittsburgh Sleep Quality Index (time frame: From enrollment to the end of intervention at 5 weeks). The study lists 2 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 NCT07816354, which also lists 20 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 11 Sep 2026.

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