AI-Guided Relaxation for Hemodialysis Anxiety

Artificial Intelligence-Guided Relaxation Interventions for Reducing Anxiety and Enhancing Coping Strategies in Patients Undergoing Hemodialysis

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Insufficiency, Chronic; Stress, Psychological; Anxiety; Maintenance Hemodialysis; Relaxation Therapy
• Intervention / Treatment: Device: AI-Guided Relaxation Platform; Other: Standard Hemodialysis Nursing Care

Detailed Description

A total of 60 adult patients undergoing maintenance hemodialysis will be recruited and randomized into two parallel groups: an intervention group (n = 30) and a control group (n = 30). Randomization will be performed using a computer-generated block randomization procedure to ensure balanced allocation. The intervention group will receive AI-guided relaxation sessions during their dialysis treatment, while the control group will receive routine standard care only. A mixed-methods approach is employed to evaluate the effectiveness, where quantitative data (anxiety, depression, coping, and relaxation levels) are collected at baseline and post-intervention, and qualitative data are gathered via semi-structured interviews to explore the intervention group's experiences and engagement with the AI technology.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Fakhry Ahmed Salem Dr, PhD; Phone Number: +201286038014; Email: mohamed.fakhry@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt, 21511
      • Recruiting
      • Faculty of Nursing, Alexandria University
      • Principal Investigator: Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin
      • Contact: Mohamed Fakhry Ahmed Salem, PhD Medical-Surgical Nursing; Phone Number: 01286038014; Email: Mohamed.Fakhry@alexu.edu.eg
    • Alexandria, Alexandria Governorate, Egypt, 2500
      • Not yet recruiting
      • Faculty of Nursing, Alexandria University
      • Contact: Email: mohamed.fakhry@alexu.edu.eg
      • Principal Investigator: Mohamed Fakhry Ahmed Salem, PHD
      • Contact: Mohamed Ahmed, PhD; Phone Number: 01286038014; Email: mohamed.fakhry@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: AI-Guided Relaxation Group; 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; 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.
Active Comparator: Control Group (No Intervention); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hospital Anxiety Scale	Assessed using the full Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS comprises 14 items across two subscales: HADS-A (items 1, 3, 5, 7, 9, 11, 13) assessing anxiety symptoms, and HADS-D (items 2, 4, 6, 8, 10, 12, 14) assessing depressive symptoms. Each subscale is scored 0-21, with thresholds of 0-7 (normal), 8-10 (borderline), and 11-21 (clinically significant). This instrument is specifically designed to detect anxiety and depression in patients with physical health conditions such as chronic kidney disease by focusing on psychological rather than somatic symptoms. Change will be calculated as the difference between baseline and post-intervention scores.	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	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.	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	Perceived relaxation will be assessed using two complementary instruments administered immediately following each AI-guided relaxation session. First, the Relaxation State Questionnaire (RSQ; Steghaus & Poth, 2022) is a validated 10-item self-report instrument measuring momentary subjective relaxation states across four subscales: Muscle Scale, Cardiovascular Scale, General Relaxation Scale, and Sleepiness Scale. Each item is rated on a 5-point Likert scale (1 = Not correct at all to 5 = Entirely correct), with reverse-scored items as indicated. Second, a 100mm Visual Analog Scale for Relaxation (VAS-R) will be used, where the left anchor (0) represents "Not relaxed at all" and the right anchor (100) represents "Completely relaxed." Patients mark a point on the line representing their current relaxation state. Higher scores on both instruments indicate a deeper and more effective state of perceived relaxation. Both measures are administered to the intervention group only.	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	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).	Time Frame: Conducted with intervention group participants only, immediately following the completion of the full 4-6 week intervention period and post-intervention assessment.

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2026
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Artificial Intelligence; Digital Health; Psychological Distress; Coping Skills; Renal Dialysis; Relaxation Therapy; End-Stage Renal Disease (ESRD); Virtual Reality (VR); Mindfulness-Based Interventions; Immersive Technology; Hemodialysis, Hospital; AI-Guided Intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Behavioral Symptoms; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Behavior; Anxiety Disorders; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Stress, Psychological
• Other Study ID Numbers: AI-IRB00013620HD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No