NCT07471828

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 3, 2026

Last Update Submit

March 12, 2026

Conditions

Keywords

MindfulnessHemodialysisPsychological Well-BeingTreatment Adherence

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 weeks from baseline

Study Arms (2)

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.

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.

Interventions

The intervention group will receive mindfulness-based nursing interventions for 6 weeks, with one session per week averaging 1 hour.

Also known as: mindfulness
The Effect of Mindfulness-Based Nursing Interventions on Psychological Well-Being and Treatment Adhe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily agreed to participate in the study
  • Receiving hemodialysis treatment for more than six months
  • Literate
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicPsychological Well-BeingTreatment Adherence and Compliance

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
yok
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 13, 2026

Study Start

December 11, 2025

Primary Completion

January 26, 2026

Study Completion

January 26, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations