AI-guided relaxation during hemodialysis for anxiety

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

This will test whether an AI-guided relaxation program can reduce anxiety and help adults receiving maintenance hemodialysis cope better during treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Alexandria University (other)
• Locations: 2 sites (Alexandria, Alexandria Governorate and 1 other locations)
• Trial ID: NCT07522944 on ClinicalTrials.gov

What this trial studies

This randomized, parallel-group trial will enroll 60 adults on maintenance hemodialysis and randomize 30 to an AI-guided relaxation program delivered during dialysis and 30 to routine care. Quantitative measures (anxiety, depression, coping, and perceived relaxation) will be collected at baseline and after the intervention using standardized scales. The trial uses block randomization to balance groups and includes semi-structured qualitative interviews with intervention participants to explore user experience and engagement with the AI platform. The mixed-methods design aims to combine statistical change scores with firsthand accounts of how the technology affected coping during treatment.

Who should consider this trial

Good fit: Adults (18+) with end-stage renal disease on maintenance hemodialysis for at least 3 months who have mild-to-moderate documented anxiety, adequate vision/hearing, and can provide informed consent are ideal candidates.

Not a fit: Patients with severe cognitive impairment, active seizure disorders or chronic vertigo, severe visual impairment, unstable medical conditions, or severe psychiatric disorders are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, the program could reduce treatment-related anxiety and improve coping and comfort during dialysis sessions.

How similar studies have performed: Relaxation, VR, and digital interventions have shown some benefit for anxiety and distress in dialysis and related settings, but AI-guided relaxation during hemodialysis is a relatively new approach with limited prior proof.

Eligibility criteria

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

Where this trial is running

Alexandria, Alexandria Governorate and 1 other locations

• Faculty of Nursing, Alexandria University — Alexandria, Alexandria Governorate, Egypt (RECRUITING)
• Faculty of Nursing, Alexandria University — Alexandria, Alexandria Governorate, Egypt (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Mohamed Fakhry Ahmed Salem Dr, PhD

Conditions: Renal Insufficiency, Chronic, Anxiety, Relaxation Therapy, Maintenance Hemodialysis, Stress, Psychological, Hemodialysis, Hospital, Renal Dialysis, End-Stage Renal Disease