Virtual Reality for Pediatric Perioperative Preparation

NCT ID
NCT07650695
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Fundación de investigación HM
Conditions
Fear, Pediatric Surgery, Preoperative Anxiety, Preoperative Care

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Preoperative Virtual Reality Intervention to Improve the Perioperative Experience in Children Undergoing Elective Surgery: A Pilot Randomized Controlled Trial

Enrollment: 56 participants (Estimated).

What is being studied

  • Device: NixiKit Virtual Reality Preparation
  • Behavioral: Standard Nursing Preoperative Preparation

Who may be eligible

Ages
3 Years to 12 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Spain

  • Mujer, Spain: 1

Sample of listed locations

  • Hospital HM Puerta del Sur — Madrid, Mujer, 28229, Spain — Recruiting

Study details

Start date
September 9, 2026
Primary completion date
January 1, 2027
Completion date
April 1, 2027
First posted
June 16, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07650695
Registry last updated
September 28, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07650695 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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