Mindfulness Meditation in Hemodialysis Patients

NCT07620990 | Recruiting

• 1 other identifier: CAU-HD-MIND-2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

This randomised controlled study aims to evaluate the effects of mindfulness meditation on sleep quality, perceived stress and symptoms levels ion hemodialysis patients. Participants in the intervention group will receive a 4 week mindfulness meditation program in addition to routine care. Outcomes will be assessed before and after the intervention using validated measurement tools.

Conditions

Hemodialysis; Stress; Sleep Quality; Symptom

Keywords

Mindfulness Meditation; Hemodialysis; Sleep Quality; Stress; Symptom

Outcome Measures

Primary Outcomes (3)

• Pittsburgh Sleep Quality İndex (PSQİ) Score

  Pittsburgh Sleep Quality İndex (PSQİ) will be used to assess sleep quality in hemodialysis patients receiving mindfulness meditation intervention. The total PSQİ score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

  Baseline and 4 weeks after intervention

• Perceived Stress Scale (PSS) Score

  The Perceived Stress Scale (PSS) will be used to assess stress levels in hemodialysis patients receiving mindfulness meditation intervention. Scores range from 0 to 40, with higher scores indicating higher perceived stress.

  Baseline and 4 week after intervention.

• Dialysis Symptom İndex (DSİ)

  TheDialysis Symptom İndex (DSİ) will be used to assess symptom burden in hemodialysis patients receiving mindfulness meditation intervention. The total score ranges from 0 to 150, with higher scores indicating greater symptom burden.

  Baseline and 4 weeks after intervention.

Study Arms (2)

Mindfulness Meditation Group

EXPERIMENTAL

Participants in this group will receive a 4 week meditation program in addition to routine hemodialysis care.

Behavioral: Mindfulness Meditation Program

Control Group

OTHER

Participants in this group will receive rouyine hemodialysis care without mindfulness meditation intervention.

Other: Routine Care

Interventions

Mindfulness Meditation Program BEHAVIORAL

Participants in the intervention group will receive a 4 week mindfulness meditation program consisting of weekly guided mindfulness sessions and home practices. The program is designed to improve sleep quality, reduce stress levels, and manage symptoms in hemodialysis patients.

Mindfulness Meditation Group

Routine Care OTHER

Participants in the control group will receive routine care provided in the hemodialysis unit without mindfulness meditation intervention.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 75 years
• Patients receiving hemodialysis treatment for at least 3 months
• Patients with cognitive functions suitable for the intervention (dementia score ≥21)
• Patient without hearing, vision or communication problems
• Patients without a psychiatric diagnosis
• Patients able to use a smartphone or tablet
• Patients not participating in another study
• Patients not using sleep medication or antipsychotic drugs

You may not qualify if:

• Patients younger than 18 years or older than 75 years
• Patients receiving hemodialysis treatment for less than 3 months
• Patients with cognitive impairment unsuitable for the intervention (dementia score ≤21)
• Patient with hearing, vision or communication disabilities
• Patients diagnosed with psychiatric disorders
• Patients unable to use a smartphone or tablet
• Patients participating in another study
• Patients using sleep medication or antipsychotic drugs

Sponsors & Collaborators

• Cyprus Aydin University: lead

Study Sites (4)

Famagusta State Hospital

Famagusta, Cyprus

RECRUITING

Dr. Akçiçek State Hospital

Kyrenia, Cyprus

RECRUITING

Cengiz Topel State Hospital

Lefka, Cyprus

RECRUITING

Dr. Burhan Nalbantoğlu State Hospital

Nicosia, Cyprus

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Sevda Sahin, RN, PhD Candidate

  Cyprus Aydin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevda Sahin, RN, PhD Candidate

CONTACT

+905488488005; sevda0584@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD Candidate

Model Details: Participants will be assigned to either the mindfulness meditation intervention group or the control group in parallel. The intervention group will receive a 4 week mindfulness meditation program, while the control group will receive routine care.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-06

Locations

CY (4)