HemodialysisMIND-HDNCT07620990
Mindfulness Meditation in Hemodialysis Patients
A study testing Mindfulness Meditation Program and Routine Care in people with Hemodialysis and Stress, run by Cyprus Aydin University at 4 sites in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemodialysis, Stress, Sleep Quality
- What is being tested?
- Mindfulness Meditation Program and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesCyprus
- Study dates
- 15 Apr 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus4 sites, 4 recruiting
- Recruiting
Famagusta State Hospital
Famagusta
Sevda Sahin, RN, PhD Candidate, +905488488005, sevda0584@hotmail.com
- Recruiting
Dr. Akçiçek State Hospital
Kyrenia
Sevda Sahin, RN, PhD Candidate, +905488488005, sevda0584@hotmail.com
- Recruiting
Cengiz Topel State Hospital
Lefka
Sevda sahin, RN, PhD Candidate, +905488488005, sevda0584@hotmail.com
- Recruiting
Dr. Burhan Nalbantoğlu State Hospital
Nicosia
Sevda Sahin, RN, PhD Candidate, +905488488005, sevda0584@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemodialysis, Stress, Sleep Quality, Symptom
- Being tested
- Mindfulness Meditation Program, Routine Care
- Keywords
- Mindfulness Meditation, Hemodialysis, Sleep Quality, Stress, Symptom
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation ProgramBehavioural
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.
Routine CareOther
Participants in the control group will receive routine care provided in the hemodialysis unit without mindfulness meditation intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation Group | Experimental | Participants in this group will receive a 4 week meditation program in addition to routine hemodialysis care. Receives: Behavioral: Mindfulness Meditation Program |
| Control Group | Other | Participants in this group will receive rouyine hemodialysis care without mindfulness meditation intervention. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Apr 2026
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyprus Aydin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Şahin, Cyprus Aydin University
- Investigators
- Sevda Sahin, RN, PhD Candidate, Principal investigator, Cyprus Aydin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620990
- Sponsor's protocol ID
- CAU-HD-MIND-2026
- Acronym
- MIND-HD
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing has not yet been determined.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Meditation on Sleep, Stress, and Symptoms in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07620990
- Acronym / sponsor ID
- MIND-HD / CAU-HD-MIND-2026
- Conditions
- Hemodialysis, Stress, Sleep Quality, Symptom
- Keywords
- Mindfulness Meditation, Hemodialysis, Sleep Quality, Stress, Symptom
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cyprus Aydin UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation Group | Experimental | Behavioral: Mindfulness Meditation ProgramParticipants in this group will receive a 4 week meditation program in addition to routine hemodialysis care. |
| Control Group | Other | Other: Routine CareParticipants in this group will receive rouyine hemodialysis care without mindfulness meditation intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation ProgramParticipants 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. | Behavioural | Mindfulness Meditation Group |
| Routine CareParticipants in the control group will receive routine care provided in the hemodialysis unit without mindfulness meditation intervention. | Other | Control Group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing has not yet been determined.
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sevda Sahin, RN, PhD Candidate principal investigator
Cyprus Aydin University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation Program and Routine Care in people with Hemodialysis and Stress, run by Cyprus Aydin University at 4 sites in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevda Sahin, RN, PhD Candidate (+905488488005, sevda0584@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality İndex (PSQİ) Score (time frame: Baseline and 4 weeks after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.