AI-Guided Personalized Relaxation for Hemodialysis Patients

NCT07522944 | Completed

• 1 other identifier: AI-IRB00013620HD
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Maintenance Hemodialysis; Stress, Psychological; Renal Insufficiency, Chronic; Anxiety; Relaxation Therapy; Quality of Life

Keywords

Hemodialysis, Hospital; Renal Dialysis; End-Stage Renal Disease (ESRD); Psychological Distress; Anxiety; Artificial Intelligence; Digital Health; Relaxation Therapy; Mindfulness-Based Interventions; Coping Skills; AI-Guided Intervention; Virtual Reality (VR); Immersive Technology; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life (HRQOL)

  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.

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

Secondary Outcomes (4)

• Anxiety Symptoms (GAD-7)

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

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

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

• Technology Acceptance of the AI-Guided Relaxation Program

  post-intervention (T1; 12 weeks).

• Qualitative Exploration of Participant Experiences

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

Study Arms (2)

Experimental: AI-Guided Relaxation Group

EXPERIMENTAL

Description: Participants received a 12-week AI-guided personalized relaxation program delivered through a smartphone application in addition to routine hemodialysis care. The intervention provided individualized relaxation exercises, including guided deep breathing, mindfulness-based relaxation, guided imagery, progressive muscle relaxation, calming audio sessions, and positive coping reinforcement messages. The AI system adapted recommendations based on participant characteristics, emotional responses, engagement patterns, and feedback. Participants completed three 20-30 minute sessions per week during and/or outside hemodialysis sessions.

Device: AI-Guided Relaxation Platform

Control Group (No Intervention)

ACTIVE COMPARATOR

Participants in this arm will receive only the standard nursing care and routine protocols typically provided during hemodialysis sessions at the study site. No AI-guided relaxation or digital intervention will be administered. Data will be collected at the same time intervals as the intervention group to serve as a baseline for comparison.

Other: Standard Hemodialysis Nursing Care

Interventions

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.

Experimental: AI-Guided Relaxation Group

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.

Control Group (No Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Faculty of Nursing, Alexandria University

Alexandria, Alexandria Governorate, 21511, Egypt

Location

Faculty of Nursing, Alexandria University

Alexandria, Alexandria Governorate, 2500, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anxiety Disorders; Stress, Psychological; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is conducted as a single-blind trial. Due to the nature of the intervention, masking of participants and care providers is not feasible, as participants are necessarily aware of whether they are receiving the AI-guided relaxation program or standard care only. However, the researcher responsible for statistical analysis and outcome assessment is blinded to group allocation throughout the entire data analysis phase. Group allocation codes are concealed from the outcomes assessor until all data collection is complete and the dataset is locked. This approach minimizes detection bias and ensures the integrity of the outcome evaluation process.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: A parallel-group randomized controlled trial in which eligible participants are randomly assigned to one of two concurrently running arms: an experimental arm receiving the AI-guided relaxation intervention in addition to routine hemodialysis care, and an active comparator arm receiving routine standard hemodialysis care only. Both arms run simultaneously throughout the intervention period of 12 weeks, with outcome assessments conducted at identical time points to enable valid between-group and within-group comparisons.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 13, 2026
• Study Start: March 29, 2026
• Primary Completion: July 15, 2026
• Study Completion: August 30, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)