[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552908":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":36,"locations":36,"responsibleParty":37,"collaborators":36,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":36,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":36,"enrollmentInfo":51,"targetDuration":36,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":66,"whyStopped":36,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":36},{"fullName":5,"class":6},"Alexandra Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VR-guided mindfulness intervention","EXPERIMENTAL","Participants will receive a 6-week home-based VR-guided mindfulness intervention using the Oculus Quest 3 (or equivalent) headset and a mindfulness application. They will be instructed to practice 10-15 minutes of VR-guided mindfulness daily. The intervention will consist of guided meditation practices, such as body scans, breath awareness, and loving-kindness meditation, delivered in immersive virtual environments designed to promote relaxation and focus.",[13],"Behavioral: VR-guided mindfulness",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham VR control","SHAM_COMPARATOR","Participants will receive a 6-week home-based sham VR intervention. They will view relaxing nature videos without mindfulness content for 10-15 minutes daily, matched for duration and VR experience with the experimental group. The sham VR control condition will use the same VR headset as the intervention group but will not include any guided mindfulness practices or instructions.",[19],"Other: Sham VR",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","VR-guided mindfulness","The VR-guided mindfulness intervention is a 6-week home-based program delivered through an Oculus Quest 3 (or equivalent) headset. Participants practice 10-15 minutes of guided mindfulness exercises daily in immersive virtual environments. The program includes various mindfulness techniques such as body scans, breath awareness, and loving-kindness meditation, designed to reduce stress and improve well-being.",[9],[27,28],"Virtual reality mindfulness","VR mindfulness",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Sham VR","The sham VR intervention is a 6-week home-based program that involves viewing relaxing nature videos without any mindfulness content. Participants use the same VR headset as the experimental group and engage with the sham content for 10-15 minutes daily, matching the duration of the experimental intervention. This sham intervention controls for the effects of using VR technology and engaging in a relaxing activity.",[15],[34,35],"Control VR","Placebo VR",null,{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Ravi Shankar","Research Fellow (Medical Affairs, Alexandra Hospital); Principal Investigator, VR-Guided Mindfulness for ESKD Caregiver Well-Being Study","100552908","vr-guided-mindfulness-for-eskd-caregiver-well-being-100552908",false,"NCT06479200","VR-Guided Mindfulness for ESKD Caregiver Well-Being","Protocol for Pilot Randomized Controlled Trial: Virtual Reality-Guided Mindfulness Intervention on Psychosocial Well-Being of End-Stage Kidney Disease Caregivers","Inclusion Criteria:\n\n* Age 21 years or older\n* Primary caregiver of a patient with end-stage kidney disease (ESKD) (stage 4 \\& 5 with - estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* Proficient in English\n\nExclusion Criteria:\n\n* Known visual or hearing impairments\n* History of motion sickness\n* Active psychosis or suicidal ideation\n* Current regular mindfulness practice\n* History of seizure, stroke, or head injury",true,"ALL","21 Years",{"count":52,"type":53},30,"ESTIMATED","INTERVENTIONAL",[56],"NA","This pilot randomized controlled trial aims to evaluate the efficacy and feasibility of a virtual reality (VR)-guided mindfulness intervention for caregivers of patients with end-stage kidney disease (ESKD). Thirty ESKD caregivers will be randomly assigned to either a 6-week VR-guided mindfulness intervention or a sham VR control group. The study will assess changes in caregiver burden, stress, anxiety, depression, quality of life, and mindfulness using validated questionnaires. Feasibility outcomes, including recruitment, retention, adherence, and participant experiences, will also be evaluated. The findings will inform the design of a future larger-scale trial and may lead to the development of an accessible, technology-based support option for ESKD caregivers.",[59],"Kidney Failure, Chronic",[61,62,63,64,65],"virtual reality","mindfulness","caregiver burden","end-stage kidney disease","pilot randomized controlled trial","NOT_YET_RECRUITING","2024-06-26",{"date":69,"type":70},"2024-06-28","ACTUAL",{"date":72,"type":53},"2024-08-01",{"date":74,"type":53},"2025-08-01",{"name":5,"class":6}]