Effects of Mindfulness Meditation on Hemodialysis Patients

NCT06936293 | Completed

• 1 other identifier: UJordan IRB Number 234/2024
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study aimed to examine the effects of mindfulness meditation on the quality of sleep, perceived stress, serum cortisol, and C-reactive protein in end-stage renal disease patients undergoing hemodialysis. Methods: An experimental study with a repeated measures design was conducted among 56 patients with end-stage renal disease undergoing hemodialysis at Jahra Hospital, Kuwait, between September 2024 and February 2025. The patients were randomly assigned to the experimental (n = 28) and control groups (n = 28). The experimental group participated in 30-minute mindfulness meditation sessions (three sessions a week for eight weeks) held during their hemodialysis sessions; the participants in the control group were instructed to sit with their eyes closed and relax for 30 min three times a week for eight weeks during hemodialysis sessions. The dependent variables of both groups were measured at baseline (T0), middle of intervention (T1), and end of intervention (T2) using the Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), and Biomedical markers (Access Cortisol Assay and CRP reagent).

Conditions

End-Stage Renal Disease; Hemodialysis Complication

Keywords

Chronic Kidney Failure; Meditation; Mindfulness; Psychological Stress; Quality of Sleep; Cortisol; C-Reactive Protein; Renal Dialysis; Kidney Diseases

Outcome Measures

Primary Outcomes (4)

• Quality of Sleep

  An Arabic version of the Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality. The PSQI includes seven dimensions of sleep characteristics: subjective sleep quality (1 item), sleep latency (2 items), sleep duration (1 item), habitual sleep efficiency (3 items), sleep disturbances (9 items), use of sleeping medication (1 item), and daytime dysfunction (2 items). When the PSQI is scored, seven different scores are calculated for each component, ranging from 0 (no problems) to 3 (severe problems) (Buysse DJ, 1989). The PSQI shows internal consistency and a reliability coefficient (Cronbach's alpha) of 0.83 for its seven components (Buysse DJ, 1989). The Arabic PSQI had a Cronbach's alpha coefficient of 0.77, indicating satisfactory reliability (Al Maqbali et al., 2020). The Arabic version provided accurate and dependable outcomes within Arabic cancer communities (Al Maqbali et al., 2020). In our study, Chronbach's α coefficient for the PSQI was 0.77.

  8 weeks

• Perceived stress

  The Arabic version of the Perceived Stress Scale (PSS) was used to measure the degree to which situations in one's life are appraised as stressful (unpredictable, uncontrollable, or overloaded). It consists of 10 elements assessed using a 5-point Likert scale (0=never, 4=very often) that are mostly not specific to any particular subgroup. Scores range from 0 to 40, with higher scores indicating greater perceived stress levels (Cohen, Kamarck, Mermelstein, \& behavior, 1983). The PSS showed internal consistency coefficients varying from 0.84 to 0.36 and a test-retest reliability of 0.85 (Cohen et al., 1983). The Arabic PSS had a Cronbach's alpha coefficient of 0.80 and an intra-correlation coefficient of 0.90 for test-retest reliability, indicating satisfactory reliability levels (Almadi, Cathers, Mansour, \& Chow, 2012). Almadi et al. (2012) confirmed the suitability of PSS for Arabic individuals. In our study, the Chronbach's α coefficient for the PSS was 0.76.

  8 weeks

• Cortisol

  Serum Cortisol: This biomarker was analyzed using the Access Cortisol Assay-33600 protocol.

  8 weeks

• C-reactive protein

  Serum CRP: This biomarker was analyzed using the CRP Reagent-447280 protocol

  8 weeks

Study Arms (2)

Patients with ESRD undergoing hemodialysis receiving mindfulness meditation intervention

EXPERIMENTAL

The participants in this group were received 30-minute mindfulness meditation sessions 3 times a week for 8 weeks (720 minutes). Patients with ESRD undergoing hemodialysis who received mindfulness meditation intervention: underwent hemodialysis thrice weekly for a minimum of one year, were at least 18 years old, had at least 65% of urea reduction rate or 1.2 of Kt/V in the past month, were capable of Arabic literacy skills, and agreed to participate. patients with cognitive dysfunction or mental retardation, suffering from rheumatoid arthritis, using a hearing aid, regularly consuming psychopharmacological drugs to reduce stress and improve sleep, participating in other psychological therapies at the time, or had prior formal training in mindfulness methods or a current meditation practice were excluded from the research.

Behavioral: Mindfulness Meditation

Control group

NO INTERVENTION

The control group including patients with ESRD undergoing hemodialysis with the inclusion criteria similar to the experimental group. The participants in this group were instructed to sit with their eyes closed and relaxed for 30 minutes 3 times a week for 8 weeks during hemodialysis sessions to control for the nonspecific effects of social interaction and environment. The timings of the control group sessions were similar to those of the experimental group, whereby if a given experimental group intervention lasted for 30 minutes, the control group participants would be asked to sit with their eyes closed and relax for 30 minutes also. However, upon completion of the study, audio recordings of the intervention protocol were provided and explained to participants in the control group.

Interventions

Mindfulness Meditation BEHAVIORAL

The experimental group received 30 minutes of mindfulness meditation according to Smith's (2005) protocol, which is a standardized theory-based intervention. Smith's (2005) protocol comprises six components: 1. Being mindful of the breath (5 minutes). 2. Being mindful of the body (5 minutes). 3. Being mindful of the thought (5 minutes) 4. Being mindful of the sound (5 minutes) 5. Being mindful during walking (5 minutes) 6. Full meditation (5 minutes). An additional two-hour educational workshop about the rationale and procedures of intervention was provided before the actual training sessions. To ensure the consistent delivery of the intervention, the researcher recorded the intervention instructions in Arabic based on the intervention protocol and sent the audio-recorded instructions to the participants via WhatsApp or email to be accessed by their cell phones and headsets. The audio-recorded intervention contents were validated by two psychologists and experts in meditation.

Patients with ESRD undergoing hemodialysis receiving mindfulness meditation intervention

Eligibility Criteria

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

You may qualify if:

• Patients with ESRD who underwent hemodialysis thrice weekly for a minimum of one year.
• Were at least 18 years old.
• Having a urea reduction rate greater than 65% or Kt/V greater than 1.2 in the past month.
• Possessing Arabic literacy skills.
• Agreed to participate.

You may not qualify if:

• Patients with cognitive dysfunction or mental retardation.
• Suffering from rheumatoid arthritis.
• Using a hearing aid.
• Regularly consuming psychopharmacological drugs to reduce stress and improve sleep.
• Participating in other psychological therapies at the time, or had prior formal training in mindfulness methods or a current meditation practice.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Dialysis center at Jahra Governmental Hospital

Al Jahra, Kuwait, 00020, Kuwait

Location

Related Publications (20)

• 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

• Kabat-Zinn J. Mindfulness-based interventions in context: past, present, and future. 2003.

  BACKGROUND

• AlSahow A, AlHelal B, Alyousef A, AlQallaf A, Marzouq A, Nawar H, Fanous G, Abdelaty M, Bahbahani Y, AlRajab H, AlTerkait A, Ali H. Renal Data from the Arab World Dialysis in Kuwait: 2013-2019. Saudi J Kidney Dis Transpl. 2020 Jul-Aug;31(4):826-830. doi: 10.4103/1319-2442.292317.

  PMID: 32801244 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

• Al-Dwaikat TN, Rababah JA, Al-Hammouri MM, Chlebowy DO. Social Support, Self-Efficacy, and Psychological Wellbeing of Adults with Type 2 Diabetes. West J Nurs Res. 2021 Apr;43(4):288-297. doi: 10.1177/0193945920921101. Epub 2020 May 16.

  PMID: 32419665 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

• AlHadi AN, AlAteeq DA, Al-Sharif E, Bawazeer HM, Alanazi H, AlShomrani AT, Shuqdar RM, AlOwaybil R. An arabic translation, reliability, and validation of Patient Health Questionnaire in a Saudi sample. Ann Gen Psychiatry. 2017 Sep 6;16:32. doi: 10.1186/s12991-017-0155-1. eCollection 2017.

  PMID: 28878812 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.

  PMID: 11914441 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

• Alhawatmeh H, Alshammari S, Rababah JA. Effects of mindfulness meditation on trait mindfulness, perceived stress, emotion regulation, and quality of life in hemodialysis patients: A randomized controlled trial. Int J Nurs Sci. 2022 Mar 8;9(2):139-146. doi: 10.1016/j.ijnss.2022.03.004. eCollection 2022 Apr.

  PMID: 35509694 BACKGROUND

• Smith, J. (2005). Relaxation, meditation, & mindfulness: A mental health practitioner's guide to new and traditional approaches. https://books.google.com/books?hl=en&lr=&id=RCLr6ap7vRgC&oi=fnd&pg=PP11&dq=Smith,+J.+C.+(2005).+Relaxation,+meditation,+and+mindfulness:+A+mental+health+practitioner's+guide+to+new+and+traditional+approaches.+New+York,+NY,+Springer+Publishing+Co.&ots=vN4OeJpowy&sig=CZBq7fwjjxGVWb3139NndQtQ-xw

  BACKGROUND

• Moosavi Nejad M, Shahgholian N, Samouei R. The effect of mindfulness program on general health of patients undergoing hemodialysis. J Educ Health Promot. 2018 Jun 12;7:74. doi: 10.4103/jehp.jehp_132_17. eCollection 2018.

  PMID: 29963567 BACKGROUND

• Aliche JC, Onyishi IE. Mindfulness and wellbeing in older adults' survivors of herdsmen attack. The mediating effect of positive reappraisal. Aging Ment Health. 2020 Jul;24(7):1132-1140. doi: 10.1080/13607863.2019.1602592. Epub 2019 Apr 24.

  PMID: 31016997 BACKGROUND

• Chu SWF, Yeam CT, Low LL, Tay WY, Foo WYM, Seng JJB. The role of mind-body interventions in pre-dialysis chronic kidney disease and dialysis patients - A systematic review of literature. Complement Ther Med. 2021 Mar;57:102652. doi: 10.1016/j.ctim.2020.102652. Epub 2020 Dec 26.

  PMID: 33373760 BACKGROUND

• Abdel-Messeih PL, Alkady MM, Nosseir NM, Tawfik MS. Inflammatory markers in end-stage renal disease patients on haemodialysis. J Med Biochem. 2020 Oct 2;39(4):481-487. doi: 10.5937/jomb0-25120.

  PMID: 33312065 BACKGROUND

• Maydych V. The Interplay Between Stress, Inflammation, and Emotional Attention: Relevance for Depression. Front Neurosci. 2019 Apr 24;13:384. doi: 10.3389/fnins.2019.00384. eCollection 2019.

  PMID: 31068783 BACKGROUND

• Vasilopoulou C, Bourtsi E, Giaple S, Koutelekos I, Theofilou P, Polikandrioti M. The Impact of Anxiety and Depression on the Quality of Life of Hemodialysis Patients. Glob J Health Sci. 2015 May 17;8(1):45-55. doi: 10.5539/gjhs.v8n1p45.

  PMID: 26234986 BACKGROUND

• Hackett ML, Jardine MJ. We Need to Talk about Depression and Dialysis: but What Questions Should We Ask, and Does Anyone Know the Answers? Clin J Am Soc Nephrol. 2017 Feb 7;12(2):222-224. doi: 10.2215/CJN.13031216. Epub 2017 Jan 26. No abstract available.

  PMID: 28126705 BACKGROUND

• Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.

  PMID: 26799456 BACKGROUND

• Finnegan-John J, Thomas VJ. The psychosocial experience of patients with end-stage renal disease and its impact on quality of life: findings from a needs assessment to shape a service. ISRN Nephrol. 2012 Oct 21;2013:308986. doi: 10.5402/2013/308986. eCollection 2013.

  PMID: 24959536 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Stress, Psychological; Sleep Initiation and Maintenance Disorders; Kidney Diseases

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; 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; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Abeer Mohammad Shaheen, PhD

  Professor at the University of Jordan, School of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data were collected by three research assistants with at least 10 years nursing experiences who were not involved in any other parts of the study. Also, the participants were randomly assigned equally to the study groups using a computerized random numbers procedure carried out by a research assistant who was not involved in any other parts of the study. A research assistant who did not participate in the other study phases collected the data, including blood sampling.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD scientist

Model Details: A repeated-measure, two-group, randomized controlled design

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 20, 2025
• Study Start: September 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: February 15, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)