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Virtual Reality for Pediatric Perioperative Preparation

RecruitingNAAges 3 Years - 12 YearsAllFundación de investigación HM
NCT07650695 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The 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. The study will assess children's fear, preoperative anxiety, cooperation during anesthesia induction, and postoperative pain. Parents' experience and s

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children aged 3 to 12 years. * Scheduled for elective surgery under anesthesia. * Parent or legal guardian owns a mobile phone. * Ability to understand simple instructions, according to clinical judgment and developmental level. * Sufficient Spanish language proficiency of the child and at least one parent or legal guardian. * Written informed consent from parents or legal guardians and child assent when applicable. Exclusion Criteria: * Emergency or urgent surgery. * Moderate to severe neurodevelopmental disorder or intellectual disability limiting understanding of the intervention or study scales. * Severe visual or hearing impairment preventing use of virtual reality. * History of photosensitive epilepsy, severe vertigo, severe motion sickness, or other conditions that could worsen with virtual reality. * Severe decompensated psychiatric disorder. * Use of intense sedative premedication before baseline assessment that prevents evaluation of preoperative anxiety.
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What it tests

  • NixiKit Virtual Reality Preparation
  • Standard Nursing Preoperative Preparation
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Where

1 site
Hospital HM Puerta del Sur
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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