Mindfulness Meditation in Hemodialysis Patients (MIND-HD)

June 1, 2026 updated by: Sevda Şahin, Cyprus Aydin University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Cyprus
      • Famagusta, Cyprus
        • Recruiting
        • Famagusta State Hospital
        • Contact:
      • Kyrenia, Cyprus
        • Recruiting
        • Dr. Akçiçek State Hospital
        • Contact:
      • Lefka, Cyprus
        • Recruiting
        • Cengiz Topel State Hospital
        • Contact:
      • Nicosia, Cyprus
        • Recruiting
        • Dr. Burhan Nalbantoğlu State Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Meditation Group
Participants in this group will receive a 4 week meditation program in addition to routine hemodialysis care.
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: Control Group
Participants in this group will receive rouyine hemodialysis care without mindfulness meditation intervention.
Other: Routine Care
Participants in the control group will receive routine care provided in the hemodialysis unit without mindfulness meditation intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality İndex (PSQİ) Score
Time Frame: Baseline and 4 weeks after intervention
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
Time Frame: Baseline and 4 week after intervention.
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)
Time Frame: Baseline and 4 weeks after intervention.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyprus Aydin University

Investigators

  • Principal Investigator: Sevda Sahin, RN, PhD Candidate, Cyprus Aydin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAU-HD-MIND-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data sharing has not yet been determined.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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