AI-Guided Relaxation for Hemodialysis Anxiety

NCT07522944 | Recruiting

• 1 other identifier: AI-IRB00013620HD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate whether a relaxation program guided by Artificial Intelligence (AI) can help reduce anxiety and improve coping mechanisms for patients receiving maintenance hemodialysis. Patients undergoing dialysis often face significant psychological stress and physical discomfort. This research uses a randomized controlled trial (RCT) with a parallel-group, pretest-posttest controlled design to compare patient well-being before and after using the AI-guided intervention. Participants will engage with an AI system designed to provide personalized relaxation techniques during their dialysis sessions. The study uses a mixed-methods approach. Quantitative: Researchers will use standardized scales to measure changes in anxiety levels, depression, coping strategies, and perceived relaxation. Qualitative: Researchers will conduct interviews with participants to understand their personal experiences, how they engaged with the AI technology, and how it influenced their ability to manage the stress of their treatment.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• Change in Generalized Anxiety Level

  Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale (Spitzer et al., 2006). It is a 7-item self-report tool where scores range from 0 to 21. Higher scores indicate greater anxiety (0-4: Minimal; 5-9: Mild; 10-14: Moderate; 15-21: Severe). Change will be calculated as the difference between baseline and post-intervention scores.

  Baseline prior to commencement of the intervention period (Week 0) and post-intervention immediately following completion of the full 4-6 week intervention period.]

Secondary Outcomes (4)

• Change in Hospital Anxiety Scale

  Time Frame: Baseline prior to commencement of the intervention period (Week 0) and post-intervention immediately following completion of the full 4-6 week intervention period.

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

  Time Frame: Baseline prior to commencement of the intervention period (Week 0) and post-intervention immediately following completion of the full 4-6 week intervention period.

• Momentary Perceived Relaxation Level as Measured by the RSQ and VAS-R

  Time Frame: Administered to the intervention group only, immediately following the completion of each individual AI-guided relaxation session throughout the 4-6 week intervention period (approximately 8-18 sessions per participant

• Qualitative Exploration of Participant Experiences

  Time Frame: Conducted with intervention group participants only, immediately following the completion of the full 4-6 week intervention period and post-intervention assessment.

Study Arms (2)

Experimental: AI-Guided Relaxation Group

EXPERIMENTAL

Participants in this arm will receive an artificial intelligence (AI)-guided relaxation intervention during their regular maintenance hemodialysis sessions. The intervention utilizes AI-driven algorithms to provide personalized relaxation techniques including deep breathing exercises, progressive muscle relaxation (PMR), guided imagery, and mindfulness-based strategies, delivered via a digital platform with headphones. Outcomes include changes in anxiety (GAD-7 and HADS), depression (HADS-D), coping strategies (Brief COPE), and perceived relaxation (RSQ and VAS-R) measured pre- and post-intervention.

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

An AI-driven software system designed to provide real-time, adaptive relaxation prompts and personalized relaxation guidance to help hemodialysis patients manage anxiety and improve psychological coping mechanisms. Each session lasts approximately 20-30 minutes and is delivered two to three times per week over four to six weeks using a tablet or mobile device with headphones during routine dialysis sessions.

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 qualify if:

• Adult patients aged 18 years or older Confirmed diagnosis of end-stage renal disease (ESRD) receiving maintenance hemodialysis for at least 3 months to ensure treatment stability Conscious, oriented, and able to communicate effectively Documented baseline anxiety at a mild-to-moderate level confirmed on initial screening using the GAD-7 or HADS prior to enrollment Adequate visual and auditory functions sufficient to interact with the AI-guided relaxation platform Willing to participate and provide written informed consent prior to enrollment

You may not qualify if:

• History of epilepsy, chronic vertigo, or seizure disorders, as AI or VR visual stimuli may trigger adverse episodes Severe cognitive impairment or diagnosed psychiatric disorders such as dementia or schizophrenia that prevent comprehension of or adherence to study instructions Acute medical complications or hemodynamic instability occurring during the dialysis session Severe visual impairment or blindness precluding use of the digital relaxation interface Skin infections or injuries on the face or head preventing comfortable use of a headset where applicable Currently enrolled in any other psychological or relaxation intervention study

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Faculty of Nursing, Alexandria University

Alexandria, Alexandria Governorate, 21511, Egypt

RECRUITING

Faculty of Nursing, Alexandria University

Alexandria, Alexandria Governorate, 2500, Egypt

NOT YET RECRUITING

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

Central Study Contacts

Mohamed Fakhry Ahmed Salem Dr, PhD

CONTACT

+201286038014; mohamed.fakhry@alexu.edu.eg

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 four to six 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: May 20, 2026
• Study Completion: May 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)