HemodialysisMindfulnessNCT07471828
The Effect of Mindfulness-Based Nursing Interventions Applied to Hemodialysis Patients on Psychological Well-Being and Treatment Adherence
A study testing The intervention group received mindfulness-based nursing interventions for six weeks in people with Hemodialysis and Chronic Kidney Disease, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Chronic kidney disease (CKD) and its treatment with hemodialysis pose significant challenges to patients' psychological well-being and adherence to complex treatment regimens. This randomized controlled trial investigated the effects of nurse-led, mindfulness-based interventions on psychological well-being and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Chronic Kidney Disease
- What is being tested?
- The intervention group received mindfulness-based nursing interventions for six weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2025to 26 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agreed to participate in the study
- Receiving hemodialysis treatment for more than six months
- Literate
- 18 years of age or older
Who cannot join
- Diagnosed severe psychiatric disorder according to DSM-5 criteria
- Auditory, visual, or cognitive impairments that could hinder participation in the educational process
- Withdrawal Criteria:
- Deterioration in general health status
- Participant's request to discontinue participation
Trial locations and contacts
1 site in 1 country.
About this study
Chronic kidney disease (CKD) and its treatment with hemodialysis pose significant challenges to patients' psychological well-being and adherence to complex treatment regimens. This randomized controlled trial investigated the effects of nurse-led, mindfulness-based interventions on psychological well-being and treatment adherence in patients undergoing hemodialysis. Eighty patients from a single dialysis center in Türkiye were randomly assigned to either an intervention group (n = 40) receiving six weekly mindfulness sessions or a control group (n = 40) receiving routine care. Data were collected using the Mindful Attention Awareness Scale (MAAS), the Psychological Well-Being Scale (PWB), and the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ) at baseline and post-intervention. Mixed-design analyses revealed significant improvements in mindfulness, psychological well-being, and all subscales of treatment adherence-including hemodialysis attendance, medication adherence, fluid management, and dietary compliance-in the intervention group compared to the control group (p < 0.001). Moderate to large effect sizes (Cohen's d = 0.36-1.70) indicate clinically meaningful changes. Pearson correlation analysis demonstrated a positive association between psychological well-being and treatment adherence (r = 0.302, p < 0.01). These findings suggest that structured, nurse-delivered mindfulness programs can simultaneously enhance psychosocial outcomes and adherence behaviors in hemodialysis patients. Integrating mindfulness-based interventions into routine nursing care may provide dual benefits by promoting emotional well-being and supporting self-regulated adherence to treatment regimens. Future research should explore long-term effects, broader patient populations, and the interplay between mindfulness, self-efficacy, and other psychosocial variables to further inform patient-centered hemodialysis care.
- Conditions
- Hemodialysis, Chronic Kidney Disease
- Being tested
- The intervention group received mindfulness-based nursing interventions for six weeks
- Keywords
- Mindfulness, Hemodialysis, Psychological Well-Being, Treatment Adherence
- Medical subject headings
- Renal Insufficiency, Chronic, Psychological Well-Being, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention group received mindfulness-based nursing interventions for six weeksOther
Also called mindfulness
The intervention group will receive mindfulness-based nursing interventions for 6 weeks, with one session per week averaging 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| The Effect of Mindfulness-Based Nursing Interventions on Psychological Well-Being and Treatment Adhe | Experimental | Behavioral intervention, Six weekly sessions of mindfulness-based nursing interventions delivered to hemodialysis patients to improve psychological well-being and treatment adherence. Receives: Other: The intervention group received mindfulness-based nursing interventions for six weeks |
| The control group | No intervention | The control group continued to receive routine dialysis treatment and did not receive any additional education during the study period. Data collection instruments were administered at baseline and at the end of the study. After completion of the research, the educational content was shared with control group participants upon request. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful Attention Awareness Scale (MAAS)
15-item scale scored on a 6-point Likert scale. Scores range from 15 to 90; higher scores indicate higher mindfulness.
Measured: 6 weeks from baseline
Psychological Well-Being Scale (PWBS)
8-item scale scored on a 7-point Likert scale. Total scores range from 8 to 56; higher scores indicate higher psychological well-being.
Measured: 6 weeks from baseline
End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)
9-item questionnaire assessing hemodialysis participation, medication adherence, fluid adherence, and diet adherence. Total scores range from 0 to 1200; higher scores indicate better adherence.
Measured: 6 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start11 Dec 2025
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prior to the study, participants were informed in detail about the research, and both written and verbal informed consent were obtained. The principal investigator completed the relevant certification program before implementing the intervention. The intervention group received mindfulness-based nursing interventions for six weeks, consisting of one session per week, each lasting approximately one hour. One week after the completion of the intervention, post-test data were collected through face-to-face interviews using the data collection forms. The control group continued to receive routine dialysis treatment and did not receive any additional education during the study period. Data collection instruments were administered at baseline and at the end of the study. After completion of the research, the educational content was shared with control group participants upon request.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Özdemir Eler, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471828
- Sponsor's protocol ID
- KA25/443
- Acronym
- Mindfulness
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared in order to protect participant privacy and data security. Although the data obtained within the scope of the study has been anonymized, it contains sensitive health information and will therefore only be used by the research team.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Nursing Interventions Applied to Hemodialysis Patients on Psychological Well-Being and Treatment Adherence
- ClinicalTrials.gov ID
- NCT07471828
- Acronym / sponsor ID
- Mindfulness / KA25/443
- Conditions
- Hemodialysis, Chronic Kidney Disease
- Keywords
- Mindfulness, Hemodialysis, Psychological Well-Being, Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 13 Mar 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.
Chronic kidney disease (CKD) and its treatment with hemodialysis pose significant challenges to patients' psychological well-being and adherence to complex treatment regimens. This randomized controlled trial investigated the effects of nurse-led, mindfulness-based interventions on psychological well-being and treatment adherence in patients undergoing hemodialysis. Eighty patients from a single dialysis center in Türkiye were randomly assigned to either an intervention group (n = 40) receiving six weekly mindfulness sessions or a control group (n = 40) receiving routine care. Data were collected using the Mindful Attention Awareness Scale (MAAS), the Psychological Well-Being Scale (PWB), and the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ) at baseline and post-intervention. Mixed-design analyses revealed significant improvements in mindfulness, psychological well-being, and all subscales of treatment adherence-including hemodialysis attendance, medication adherence, fluid management, and dietary compliance-in the intervention group compared to the control group (p < 0.001). Moderate to large effect sizes (Cohen's d = 0.36-1.70) indicate clinically meaningful changes. Pearson correlation analysis demonstrated a positive association between psychological well-being and treatment adherence (r = 0.302, p < 0.01). These findings suggest that structured, nurse-delivered mindfulness programs can simultaneously enhance psychosocial outcomes and adherence behaviors in hemodialysis patients. Integrating mindfulness-based interventions into routine nursing care may provide dual benefits by promoting emotional well-being and supporting self-regulated adherence to treatment regimens. Future research should explore long-term effects, broader patient populations, and the interplay between mindfulness, self-efficacy, and other psychosocial variables to further inform patient-centered hemodialysis care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prior to the study, participants were informed in detail about the research, and both written and verbal informed consent were obtained. The principal investigator completed the relevant certification program before implementing the intervention. The intervention group received mindfulness-based nursing interventions for six weeks, consisting of one session per week, each lasting approximately one hour. One week after the completion of the intervention, post-test data were collected through face-to-face interviews using the data collection forms. The control group continued to receive routine dialysis treatment and did not receive any additional education during the study period. Data collection instruments were administered at baseline and at the end of the study. After completion of the research, the educational content was shared with control group participants upon request.
| Arm | Type | Receives |
|---|---|---|
| The Effect of Mindfulness-Based Nursing Interventions on Psychological Well-Being and Treatment Adhe | Experimental | Other: The intervention group received mindfulness-based nursing interventions for six weeksBehavioral intervention, Six weekly sessions of mindfulness-based nursing interventions delivered to hemodialysis patients to improve psychological well-being and treatment adherence. |
| The control group | No intervention | –The control group continued to receive routine dialysis treatment and did not receive any additional education during the study period. Data collection instruments were administered at baseline and at the end of the study. After completion of the research, the educational content was shared with control group participants upon request. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily agreed to participate in the study
- Receiving hemodialysis treatment for more than six months
- Literate
- 18 years of age or older
Key exclusion criteria (5 listed)
- Diagnosed severe psychiatric disorder according to DSM-5 criteria
- Auditory, visual, or cognitive impairments that could hinder participation in the educational process
- Deterioration in general health status
- Participant's request to discontinue participation
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 |
|---|---|---|
| The intervention group received mindfulness-based nursing interventions for six weeksAlso: mindfulnessThe intervention group will receive mindfulness-based nursing interventions for 6 weeks, with one session per week averaging 1 hour. | Other | The Effect of Mindfulness-Based Nursing Interventions on Psychological Well-Being and Treatment Adhe |
Primary outcome
Mindful Attention Awareness Scale (MAAS)
Time frame: 6 weeks from baseline
15-item scale scored on a 6-point Likert scale. Scores range from 15 to 90; higher scores indicate higher mindfulness.
Psychological Well-Being Scale (PWBS)
Time frame: 6 weeks from baseline
8-item scale scored on a 7-point Likert scale. Total scores range from 8 to 56; higher scores indicate higher psychological well-being.
End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ)
Time frame: 6 weeks from baseline
9-item questionnaire assessing hemodialysis participation, medication adherence, fluid adherence, and diet adherence. Total scores range from 0 to 1200; higher scores indicate better adherence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Individual patient data will not be shared in order to protect participant privacy and data security. Although the data obtained within the scope of the study has been anonymized, it contains sensitive health information and will therefore only be used by the research team.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention group received mindfulness-based nursing interventions for six weeks in people with Hemodialysis and Chronic Kidney Disease, run by Baskent University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindful Attention Awareness Scale (MAAS) (time frame: 6 weeks from baseline). 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 13 Mar 2026.