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AI-Guided Personalized Relaxation for Hemodialysis Patients

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fields
  2. Notable Primary endpoint(s) modified Show 9 more changesShow less
    • Trial completed
    • Final enrollment: 125 participants (planned 60)
    • Primary completion date changed from estimate of May 20, 2026 to Jul 15, 2026
    • Study completion date changed from estimate of May 30, 2026 to Aug 30, 2026
    • Eligibility criteria shortened, about 59 words
    • Secondary endpoints revised (4)
    • Study description shortened, about 111 words
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 1 word
  3. Minor Primary completion pushed from Apr 20, 2026 to May 20, 2026
    • Study completion pushed from Apr 30, 2026 to May 30, 2026
    v3
  4. Notable Recruitment openedv2 Show 5 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Apr 7, 2026 to Mar 29, 2026
    • Secondary endpoints revised (4)
    • Study description expanded, about 111 words
    • Eligibility criteria expanded, about 4 words
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients undergoing maintenance hemodialysis frequently experience impaired health-related quality of life, anxiety, and difficulties in coping with the long-term demands of treatment. Artificial intelligence (AI)-guided interventions may provide personalized psychological support and promote adaptive coping through tailored relaxation strategies. This randomized controlled mixed-methods trial evaluates the effectiveness of an AI-guided personalized relaxation intervention delivered through a smartphone application among adults receiving maintenance hemodialysis. Participants are randomly assigned to either an intervention group receiving AI-guided personalized relaxation in addition to routine hemodialysis care or a control group receiving routine care alone. The 6-week intervention includes individualized breathing exercises, mindfulness practices, guided imagery, progressive muscle relaxation, and adaptive feedback generated according to participant characteristics, emotional responses, and engagement patterns. The primary outcome is health-related quality of life measured using the Kidney Disease Quality of Life-36 (KDQOL-36™). Secondary outcomes include anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7), coping strategies measured by the Brief COPE Inventory, and user acceptance of the AI-guided intervention. Qualitative interviews are conducted with intervention participants to explore their experiences, perceived benefits, feasibility, and acceptability of the intervention. The study aims to determine whether AI-guided personalized relaxation can improve quality of life, reduce anxiety, and enhance coping among patients undergoing maintenance hemodialysis while providing insight into the acceptability and feasibility of integrating AI-supported psychosocial interventions into routine dialysis care.
Trial Details
NCT Number NCT07522944
Lead Sponsor Alexandria University
Conditions
(from sponsor)
Renal Insufficiency, Chronic, Anxiety, Relaxation Therapy, Maintenance Hemodialysis, Stress, Psychological, Quality of Life
Related terms Anxiety Disorders, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Stress, Psychological
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov