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
- Preoperative Anxiety
- Fear
- Pediatric Surgery
- Preoperative Care
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Fundación de investigación HM
- Enrolment target
- 56
- Started
- 9 September 2026
- Main results due
- 1 January 2027
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Ages 3 years to 12 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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 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.
Study sites(1)
Hospital HM Puerta del Sur
Madrid, Mujer, Spain
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07650695. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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