[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633150":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":72,"collaborators":26,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":26,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Alexandria University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: AI-Guided Relaxation Platform",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Standard Hemodialysis Nursing Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mohamed Fakhry Ahmed Salem Dr, PhD","CONTACT","+201286038014","mohamed.fakhry@alexu.edu.eg",[38,60],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Faculty of Nursing, Alexandria University","RECRUITING","Alexandria","Alexandria Governorate","21511","Egypt","EG",{"type":47,"coordinates":48},"Point",[49,50],29.91582,31.20176,{"lat":50,"lon":49},[53,57],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Mohamed Fakhry Ahmed Salem, PhD Medical-Surgical Nursing","01286038014","Mohamed.Fakhry@alexu.edu.eg",{"name":58,"role":59,"phone":26,"phoneExt":26,"email":26},"Mohamed Fakhry Ahmed Salem, PhD in Medical-Surgical Nursin","PRINCIPAL_INVESTIGATOR",{"facility":39,"status":61,"city":41,"state":42,"zip":62,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"NOT_YET_RECRUITING","2500",{"type":47,"coordinates":64},[49,50],{"lat":50,"lon":49},[67,69,70],{"name":68,"role":34,"phone":55,"phoneExt":26,"email":36},"Mohamed Ahmed, PhD",{"name":26,"role":34,"phone":26,"phoneExt":26,"email":36},{"name":71,"role":59,"phone":26,"phoneExt":26,"email":26},"Mohamed Fakhry Ahmed Salem, PHD",{"type":59,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Mohamed Fakhry Ahmed Salem","Dr","100633150","ai-guided-relaxation-for-hemodialysis-anxiety-100633150",false,"NCT07522944","AI-Guided Relaxation for Hemodialysis Anxiety","Artificial Intelligence-Guided Relaxation Interventions for Reducing Anxiety and Enhancing Coping Strategies in Patients Undergoing Hemodialysis","Inclusion Criteria:\n\nAdult 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\n\nExclusion Criteria:\n\nHistory 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","ALL","18 Years",{"count":85,"type":86},60,"ESTIMATED","INTERVENTIONAL",[89],"NA","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.\n\nParticipants 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.",[92,93,94,95,96],"Renal Insufficiency, Chronic","Anxiety","Relaxation Therapy","Maintenance Hemodialysis","Stress, Psychological",[98,99,100,101,93,102,103,94,104,105,106,107,108],"Hemodialysis, Hospital","Renal Dialysis","End-Stage Renal Disease (ESRD)","Psychological Distress","Artificial Intelligence","Digital Health","Mindfulness-Based Interventions","Coping Skills","AI-Guided Intervention","Virtual Reality (VR)","Immersive Technology","2026-05-07",{"date":111,"type":112},"2026-05-12","ACTUAL",{"date":114,"type":112},"2026-03-29",{"date":116,"type":86},"2026-05-30",{"name":5,"class":6},2]