[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659741":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":29,"studyPopulation":21,"armGroups":30,"interventions":41,"overallOfficials":21,"centralContacts":49,"locations":21,"responsibleParty":58,"collaborators":21,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":21,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":21,"enrollmentInfo":71,"targetDuration":21,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":83,"whyStopped":21,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":21},{"fullName":5,"class":6},"Islamic University of Najaf","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Pain intensity","Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.","Immediately before and immediately after the hemodialysis session\u002Fintervention",[14,17],{"measure":15,"description":16,"timeFrame":12},"Anxiety","Anxiety measured using the 6-item State-Trait Anxiety Inventory (STAI-6), with higher scores indicating greater state anxiety.",{"measure":18,"description":19,"timeFrame":20},"Fatigue","Fatigue severity will be assessed using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no fatigue and 10 indicates the worst possible fatigue. Higher scores indicate greater fatigue severity.","Immediately before and immediately after the hemodialysis session\u002Fintervention.",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","Parallel Assignment Participants will be randomly assigned to either the virtual reality-guided imagery intervention group or the routine-care control group. Each participant will remain in the assigned group throughout the study.","SUPPORTIVE_CARE",{"masking":28,"maskingDescription":21,"whoMasked":21},"NONE","Hemodialysis is an essential treatment for patients with end-stage kidney disease; however, patients undergoing maintenance hemodialysis may experience various physical and psychological symptoms during treatment. These symptoms may negatively affect patients' comfort and overall treatment experience. Virtual reality-guided imagery (VRGI) is a non-pharmacological nursing intervention that combines immersive virtual reality environments with guided imagery techniques. The intervention is designed to provide a relaxing and engaging experience that may help patients shift their attention away from the hemodialysis environment and treatment-related discomfort. In this randomized controlled trial, VRGI will be provided to eligible adult patients receiving maintenance hemodialysis. Participants allocated to the intervention group will receive standardized VR-guided imagery using a virtual reality headset during a hemodialysis session, while participants in the control group will receive routine care. The intervention will be delivered in a standardized manner to ensure consistency across participants. The study will evaluate the effect of VRGI on the prespecified study outcomes and compare changes between the intervention and routine-care groups. The study is based on the use of a non-pharmacological, patient-centered nursing intervention intended to promote comfort during hemodialysis. The findings may provide evidence regarding the feasibility and potential benefits of incorporating virtual reality-guided imagery into nursing care for patients receiving maintenance hemodialysis.",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Arm 1 VRGI","EXPERIMENTAL","Participants assigned to this group will receive standardized virtual reality-guided imagery (VRGI) during a hemodialysis session in addition to routine care. The intervention will be delivered using a virtual reality headset and standardized guided imagery content designed to provide a relaxing and immersive experience during hemodialysis.",[36],"Behavioral: virtual reality-guided imagery (VRGI)",{"label":38,"type":39,"description":40,"interventionNames":21},"Arm 2 Routine care","NO_INTERVENTION","Participants assigned to this group will receive routine hemodialysis care according to the usual clinical practice of the dialysis unit without the virtual reality guided imagery intervention",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"BEHAVIORAL","virtual reality-guided imagery (VRGI)","Virtual reality-guided imagery (VRGI) is a non pharmacological behavioral intervention delivered during a hemodialysis session using a virtual reality headset. Participants will experience standardized immersive visual content accompanied by guided imagery audio designed to promote relaxation and provide distraction from the hemodialysis environment. The intervention will be delivered in a standardized manner in addition to routine hemodialysis care.",[32],[48],"VRGI",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":21,"email":54},"Thulfiqar Mohammed Abdalhussien, PhD candidate","CONTACT","07831476489","thulfiqar.abd2402p@conursing.uobaghdad.edu.iq",{"name":56,"role":52,"phone":57,"phoneExt":21,"email":21},"Ameer Wahhed Mohammed, PhD candidate","07800526273",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Thoalfokar Mohammed","PhD Candidate","100659741","virtual-reality-guided-imagery-in-hemodialysis-patients--vrgi-hd--100659741",false,"NCT07867444","Virtual Reality-Guided Imagery in Hemodialysis Patients ( VRGI-HD )","Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Patients Undergoing Hemodialysis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged ≥18 years.\n* Diagnosed with end-stage kidney disease (ESKD) and receiving maintenance hemodialysis.\n* Undergoing hemodialysis three times per week. Receiving maintenance hemodialysis for at least 3 months before enrollment.\n* Able to communicate verbally and understand Arabic.\n* Conscious, alert, and able to understand the study procedures and provide written informed consent.\n* Able to safely use a VR headset and tolerate the VRGI intervention.\n* Agree to participate in the study and comply with the study procedures .\n\nExclusion Criteria:\n\n* Patients with cognitive impairment or altered mental status that may interfere with understanding the intervention or completing the assessment.\n* Patients with severe visual or auditory impairment that prevents effective use of the VR intervention.\n* Patients with a history of severe motion sickness, vestibular disorders, or significant intolerance to VR.\n* Patients who are hemodynamically unstable during the dialysis session.\n* Patients experiencing an acute medical complication requiring interruption or modification of the dialysis session.\n* Patients who have participated in a similar VR intervention recently, if this could influence the study outcomes.\n* Patients who are unable to complete the intervention or outcome assessments.","ALL","18 Years",{"count":72,"type":73},80,"ESTIMATED","INTERVENTIONAL",[76],"NA","This randomized controlled trial aims to evaluate the effect of virtual reality guided imagery on selected health outcomes among adult patients receiving maintenance hemodialysis. Eligible participants will be randomly assigned to either a virtual reality-guided imagery intervention group or a routine-care control group. Participants in the intervention group will receive virtual reality guided imagery during hemodialysis sessions using a virtual reality headset and standardized guided imagery content, while the control group will receive routine care. The study will assess whether virtual reality-guided imagery can improve the selected outcomes among patients undergoing hemodialysis.",[79],"End-Stage Kidney Disease (ESKD)",[81,82,48,18],"Pain","Anxaiety","NOT_YET_RECRUITING","2026-10-06",{"date":86,"type":87},"2026-10-09","ACTUAL",{"date":89,"type":73},"2027-01-01",{"date":91,"type":73},"2027-04-01",{"name":5,"class":6}]