RecruitingNot ApplicableNCT07522944

AI-Guided Relaxation for Hemodialysis Anxiety

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


Sponsor

Alexandria University

Enrollment

60 participants

Start Date

Mar 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria1

  • 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

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Interventions

DEVICEAI-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.

OTHERStandard 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.


Locations(2)

Faculty of Nursing, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Faculty of Nursing, Alexandria University

Alexandria, Alexandria Governorate, Egypt

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NCT07522944


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