Mindfulness for Saudi Hemodialysis Patients

NCT07816354 | Completed

• 1 other identifier: 25-0055
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Hemodialysis; End Stage Chronic Renal Failure

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of intervention at 5 weeks

• 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")

  From enrollment to the end of intervention at 5 weeks

Secondary Outcomes (2)

• The Emotion Regulation Questionnaire (ERQ)

  From enrollment to the end of intervention at 5 weeks

• Mindful Attention Awareness Scale (MAAS)

  From enrollment to the end of intervention at 5 weeks

Study Arms (2)

Mindfulness-based Intervention

EXPERIMENTAL

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 thoughts.

Behavioral: Mindfulness-Based Intervention

Control Group

NO INTERVENTION

The control arm participants received no additional psychological or behavioural intervention during the trial

Interventions

Mindfulness-Based Intervention BEHAVIORAL

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

Mindfulness-based Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being aged 18 or above
• having a history of maintenance dialysis for three months
• having the capacity to self-report

You may not qualify if:

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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead
• Fakeeh College for Medical Sciences: collaborator

Study Sites (1)

Dr. Sulima Fakeeh Hospital

Jeddah, Mecca Region, 23717, Saudi Arabia

Location

Related Publications (20)

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

  BACKGROUND

• 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.

  PMID: 30575050 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34643641 BACKGROUND

• 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.

  PMID: 29784228 BACKGROUND

• 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.

  PMID: 34205915 BACKGROUND

• 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.

  PMID: 7726811 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33449820 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12916575 BACKGROUND

• 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.

  PMID: 9457784 BACKGROUND

• 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.

  PMID: 29211754 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 12703651 BACKGROUND

• Alshammari, S. M., Shaheen, A. M., Alshammari, A. Z., & Hamdan-Mansour, A. M. (2025). Mindfulness meditation effects on sleep, stress, and physiological biomarkers in hemodialysis patients: A randomized controlled trial. Health Psychology Research. 13(3), e81240021. https://doi.org/10.14440/hpr.0186https://doi.org/10.14440/hpr.0186

  BACKGROUND

• Almutary, H., Bonner, A., & Douglas, C. (2021). Symptom burden in chronic kidney disease: A systematic review. Journal of Renal Care, 47(1), 3-15. https://doi.org/10.1111/jorc.12334

  BACKGROUND

• Almutary, H., Alghamdi, S., Mezan, A., Farsi, H., Alsayegh, A., Alqurashi, A., & Alharazi, R. (2025). Sleep quality and fatigue among hemodialysis patients. International Journal of Noncommunicable Diseases, 10(1), 33-40. https://doi.org/10.4103/jncd.jncd_114_24

  BACKGROUND

• Alhawatmeh H, Najadat I, Hweidi I, Abuhammad S. The impact of mindfulness meditation on pro-inflammatory biomarkers in patients with end-stage renal disease: A randomized trial. SAGE Open Med. 2024 Dec 18;12:20503121241308995. doi: 10.1177/20503121241308995. eCollection 2024.

  PMID: 39713266 BACKGROUND

• Alhawatmeh H, Najadat IA, Hweidi IM. Mindfulness-based intervention as a symptom management strategy in patients with end-stage renal disease: A controlled clinical trial. Int J Nurs Pract. 2024 Dec;30(6):e13282. doi: 10.1111/ijn.13282. Epub 2024 Jun 16.

  PMID: 38880954 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: January 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 30, 2025
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

SA (1)