- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471828
The Effect of Mindfulness-Based Nursing Interventions Applied to Hemodialysis Patients on Psychological Well-Being and Treatment Adherence (Mindfulness)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey (Türkiye)
- Baskent University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Voluntarily agreed to participate in the study
Receiving hemodialysis treatment for more than six months
Literate
18 years of age or older
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The Effect of Mindfulness-Based Nursing Interventions on Psychological Well-Being and Treatment Adhe
Behavioral intervention, Six weekly sessions of mindfulness-based nursing interventions delivered to hemodialysis patients to improve psychological well-being and treatment adherence.
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The intervention group will receive mindfulness-based nursing interventions for 6 weeks, with one session per week averaging 1 hour.
Other Names:
|
|
No Intervention: The control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks from baseline
|
|
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.
|
6 weeks from baseline
|
|
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.
|
6 weeks from baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Behavior
- Health Behavior
- Personal Satisfaction
- Renal Insufficiency, Chronic
- Psychological Well-Being
- Treatment Adherence and Compliance
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Cognitive Behavioral Therapy
- Mindfulness
Other Study ID Numbers
- KA25/443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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