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NCT Number: NCT07522944

AI-Guided Personalized Relaxation for Hemodialysis Patients

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 12-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.

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Key information

Conditions

Renal Insufficiency, Chronic Anxiety Anxiety Disorders Behavior Behavioral Symptoms Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Maintenance Hemodialysis Male Urogenital Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Relaxation Therapy Renal Insufficiency Stress, Psychological Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing, Alexandria University, Alexandria, Alexandria Governorate, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 years or older. Diagnosed with end-stage renal disease (ESRD). Receiving maintenance hemodialysis for at least 3 months. Able to communicate and complete study questionnaires. Possession of, or access to, a smartphone capable of running the study application.

Willing and able to provide written informed consent. Exclusion Criteria Severe cognitive impairment or inability to complete study assessments. Severe psychiatric illness requiring acute treatment or hospitalization. Significant visual, hearing, or communication impairment preventing participation in the intervention.

Participation in another psychosocial, behavioral, or relaxation intervention study during the study period.

Inability or unwillingness to use the smartphone-based intervention. Withdrawal of consent at any stage of the study.

Treatment and study plan

AI-Guided Relaxation Platform

Device

Participants received a 12-week AI-guided personalized relaxation program delivered through a smartphone application. The intervention included individualized breathing exercises, mindfulness-based relaxation, guided imagery, progressive muscle relaxation, calming audio sessions, and positive coping reinforcement messages. An AI-based personalization system adapted relaxation recommendations according to participant characteristics, emotional responses, engagement patterns, and user feedback. Participants completed three 20-30 minute sessions per week in addition to routine hemodialysis care.

Standard Hemodialysis Nursing Care

Other

Participants in the control group will receive the routine standard of care provided during maintenance hemodialysis sessions at the study site. This includes standard medical and nursing protocols, monitoring of vital signs, and routine patient education. No AI-guided relaxation interventions will be administered to this group. Data collection (anxiety, depression, and coping assessments) will be conducted at the same time intervals as the intervention group to provide a baseline for comparison.

Primary outcomes

  1. Health-Related Quality of Life (HRQOL)

    Time frame: Baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3).

    Health-related quality of life was assessed using the Kidney Disease Quality of Life-36™ (KDQOL-36™), a validated disease-specific instrument for patients undergoing hemodialysis. The questionnaire generates scores for the Physical Component Summary (PCS), Mental Component Summary (MCS), Burden of Kidney Disease, Symptoms/Problems of Kidney Disease, and Effects of Kidney Disease domains. Scores range from 0 to 100, with higher scores indicating better quality of life.

Secondary outcomes

  1. Anxiety Symptoms (GAD-7)

    Time frame: Baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3).

    Anxiety symptoms were assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.

  2. Change in Coping Strategies as Measured by the Brief Coping Orientation to Problems Experienced Inventory

    Time frame: Baseline (T0), immediately post-intervention (T1), 1-month follow-up (T2), and 3-month follow-up (T3).

    Assessed using the Brief Coping Orientation to Problems Experienced (Brief COPE) Inventory (Carver, 1997). The inventory consists of 28 items covering 14 subscales including active coping, planning, positive reframing, acceptance, emotional support, and behavioral disengagement, among others. Each item is scored on a 4-point Likert scale ranging from 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot"). Scores for each subscale range from a minimum of 2 to a maximum of 8. Higher scores on adaptive coping subscales indicate greater reliance on constructive coping strategies. Change will be calculated as the difference between baseline scores and post-intervention scores.

  3. Technology Acceptance of the AI-Guided Relaxation Program

    Time frame: post-intervention (T1; 12 weeks).

    Technology acceptance was assessed using an adapted Technology Acceptance Model questionnaire measuring perceived usefulness, perceived ease of use, user satisfaction, and behavioral intention toward continued use of the AI-guided relaxation program. Higher scores indicate greater acceptance.

  4. Qualitative Exploration of Participant Experiences

    Time frame: Time Frame: post-intervention (T1; 12 weeks).

    Semi-structured interviews will be conducted with participants in the intervention group upon completion of the intervention period to explore their personal experiences, levels of engagement, perceived ease of use of the AI system, and overall satisfaction with the AI-guided relaxation sessions. The interviews will gather detailed insights into how the technology influenced participants' ability to cope with the dialysis procedure and manage treatment-related anxiety. Each interview will last approximately 20-30 minutes and will be audio-recorded with participants' prior informed consent. Data will be analyzed using thematic analysis following the six-phase framework described by Braun and Clarke (2006).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Artificial Intelligence-Guided Personalized Relaxation Intervention for Improving Quality of Life, Reducing Anxiety, and Enhancing Coping Strategies in Patients Undergoing Hemodialysis: A Mixed-Methods Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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