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Recruiting NCT07620990

Mindfulness Meditation in Hemodialysis Patients

No phase Interventional Hemodialysis Stress Sleep Quality Symptom

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness Meditation Program, Routine Care.
Who it may be relevant to
Registry conditions: Hemodialysis, Stress, Sleep Quality, Symptom. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Cyprus
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Mindfulness Meditation on Sleep, Stress, and Symptoms in Hemodialysis Patients: A Randomized Controlled Trial

Overview

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.

Detailed description

This study is designed as a randomized controlled experimental trial conducted in hemodialysis units in Northern Cyprus. Hemodialysis patients will be randomly assigned to intervention and control groups.The intervention group will participane in a structured 4 week mindfulness meditation program delivered through guided sessions, while the control group will continue receiving routine care. The study aims to determine the effectiveness of mindfulness meditation on sleep quality, stress levels and symptoms management in hemodialysis patients. Data will be collected before and after the intervention using validated assessment scales.

Interventions

  • Behavioral Mindfulness Meditation Program
    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.
  • Other Routine Care
    Participants in the control group will receive routine care provided in the hemodialysis unit without mindfulness meditation intervention.

Primary outcome measures

  • Pittsburgh Sleep Quality İndex (PSQİ) Score [Time frame: Baseline and 4 weeks after intervention]
  • Perceived Stress Scale (PSS) Score [Time frame: Baseline and 4 week after intervention.]
  • Dialysis Symptom İndex (DSİ) [Time frame: Baseline and 4 weeks after intervention.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Cyprus · 4 centers
  • Famagusta State Hospital — Famagusta
  • Dr. Akçiçek State Hospital — Kyrenia
  • Cengiz Topel State Hospital — Lefka
  • Dr. Burhan Nalbantoğlu State Hospital — Nicosia

Identifiers

NCT: NCT07620990 · CAU-HD-MIND-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗