[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641617":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":38,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":26,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Fundación de investigación HM","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Reality Preparation","EXPERIMENTAL","Participants assigned to this arm will receive a virtual reality-based preoperative preparation program using the NixiKit system before elective surgery. The intervention consists of an immersive 360-degree virtual tour of the perioperative pathway, including the preoperative area, operating room, and recovery room, delivered through a virtual reality headset connected to amobile phone. The experience is designed to familiarize children with the surgical environment, reduce fear and anxiety, and improve preparedness for surgery. Participants will also receive routine perioperative care provided by the hospital.",[13],"Device: NixiKit Virtual Reality Preparation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Nursing Preparation","ACTIVE_COMPARATOR","Participants assigned to this arm will receive the standard preoperative preparation routinely provided by nursing staff before elective surgery. This preparation includes a verbal explanation of the perioperative process, including admission procedures, transfer to the preoperative area, anesthesia induction, the operating room environment, and postoperative recovery. Children and their parents will have the opportunity to ask questions and receive clarification regarding the surgical procedure. Participants will receive routine perioperative care according to hospital practice.",[19],"Behavioral: Standard Nursing Preoperative Preparation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","NixiKit Virtual Reality Preparation","Participants assigned to the intervention group will receive a virtual reality-based preoperative preparation program using the NixiKit system (Nixi for Children). The intervention consists of an immersive 360-degree virtual tour delivered through a pediatric virtual reality headset connected to a smartphone. The experience guides children through the perioperative journey, including the preoperative area, operating room, and recovery room, using age-appropriate narration and storytelling designed to familiarize them with the surgical environment and procedures. The virtual experience lasts approximately 10 to 15 minutes and is delivered during hospital admission before elective surgery. In addition to the virtual reality experience, participants receive the standard components of the NixiKit package, including educational and supportive materials intended to reinforce preparation for surgery.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Standard Nursing Preoperative Preparation","Participants assigned to the control group will receive the standard preoperative preparation routinely provided by nursing staff. This preparation includes a verbal explanation of the perioperative process, including transfer to the preoperative area, operating room procedures, anesthesia induction, and postoperative recovery, as well as the opportunity for children and their parents to ask questions and receive clarification about the surgical process.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Cayetana Ruiz Zaldibar, Dr","CONTACT","695829472","crzaldibar@ucjc.edu",{"type":39,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100641617","virtual-reality-for-pediatric-perioperative-preparation-100641617",false,"NCT07650695","Virtual Reality for Pediatric Perioperative Preparation","Preoperative Virtual Reality Intervention to Improve the Perioperative Experience in Children Undergoing Elective Surgery: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged 3 to 12 years.\n* Scheduled for elective surgery under anesthesia.\n* Parent or legal guardian owns a mobile phone.\n* Ability to understand simple instructions, according to clinical judgment and developmental level.\n* Sufficient Spanish language proficiency of the child and at least one parent or legal guardian.\n* Written informed consent from parents or legal guardians and child assent when applicable.\n\nExclusion Criteria:\n\n* Emergency or urgent surgery.\n* Moderate to severe neurodevelopmental disorder or intellectual disability limiting understanding of the intervention or study scales.\n* Severe visual or hearing impairment preventing use of virtual reality.\n* History of photosensitive epilepsy, severe vertigo, severe motion sickness, or other conditions that could worsen with virtual reality.\n* Severe decompensated psychiatric disorder.\n* Use of intense sedative premedication before baseline assessment that prevents evaluation of preoperative anxiety.","ALL","3 Years","12 Years",{"count":51,"type":52},56,"ESTIMATED","INTERVENTIONAL",[55],"NA","This pilot randomized controlled trial will evaluate whether a virtual reality (VR) preparation program can improve the perioperative experience of children aged 3 to 12 years undergoing elective surgery. Children scheduled for surgery at HM Hospital in Madrid, Spain, will be randomly assigned to receive either a VR-based educational experience (NixiKit) or the standard preoperative preparation routinely provided by nursing staff.\n\nThe VR intervention includes an immersive virtual tour of the preoperative area, operating room, and recovery room, designed to familiarize children with the surgical process in an age-appropriate manner. The control group will receive the usual verbal explanation and support provided by nurses before surgery.\n\nThe study will assess children's fear, preoperative anxiety, cooperation during anesthesia induction, and postoperative pain. Parents' experience and satisfaction with care will also be evaluated. The results of this pilot study will help determine the feasibility and potential effectiveness of VR as a nursing-led preparation strategy for pediatric surgical patients.",[58,59,60,61],"Preoperative Anxiety","Fear","Pediatric Surgery","Preoperative Care",[63,60,64,65,66,67,68],"Virtual Reality","Perioperative Care","children","Nursing intervention","fear","anxiety","NOT_YET_RECRUITING","2026-06-12",{"date":72,"type":73},"2026-06-16","ACTUAL",{"date":75,"type":52},"2026-07-01",{"date":77,"type":52},"2027-04-01",{"name":5,"class":6}]