N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Not applicable ClinicalTrials.gov

Virtual Reality for Pediatric Perioperative Preparation

Sponsor: Fundación de investigación HM • ClinicalTrials.gov ID: NCT07650695

Registry updated: 2026-09-28
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • NixiKit Virtual Reality Preparation (Device)
    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.
  • Standard Nursing Preoperative Preparation (Behavioral)
    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.

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.

Conditions

Preoperative Anxiety Fear Pediatric Surgery Preoperative Care

Locations

  • Hospital HM Puerta del Sur — Madrid, Mujer, Spain
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record