Virtual Reality for Pediatric Perioperative Preparation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorFundación de investigación HM
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NixiKit Virtual Reality Preparation
DeviceParticipants 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
BehavioralParticipants 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality PreparationExperimental treatment 1 intervention
Group B: Standard Nursing PreparationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Preoperative Anxiety
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS), an observational instrument widely used in pediatric surgical populations. The scale evaluates activity, vocalization, emotional expressivity, apparent arousal, and interaction with parents. Total scores range from 23.3 to 100, with higher scores indicating greater anxiety. The primary outcome will be the change in mYPAS score between baseline assessment and post-intervention assessment.
Time frame
From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery2
Change in Fear Level
Measured using the Children's Fear Scale (CFS). Scores range from 0 to 4, with higher scores indicating greater fear. The outcome will be the change in fear score from baseline to immediately after the intervention.
Time frame
From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgerySecondary outcomes
1
Cooperation During Anesthesia Induction
Cooperation during anesthesia induction will be assessed using the Induction Compliance Checklist (ICC). The checklist includes 10 observational items scored as 0 or 1, with higher scores indicating more negative behaviors and poorer cooperation during induction.
Time frame
During anesthesia induction, after transfer to the operating room on the day of surgery.2
Postoperative Pain
Pain will be assessed using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Time frame
Day of surgery, after return to the hospital room3
Parent Experience and Satisfaction
Parent experience and satisfaction will be assessed using the EMCA Pediatric Hospitalization Questionnaire, a parent-reported measure of pediatric inpatient experience. The questionnaire includes multiple items evaluating information provided, communication with healthcare professionals, participation in care, hospital environment, and overall quality of care. Individual questionnaire items will be analyzed according to their response categories, with more favorable responses indicating a more positive care experience.
Time frame
At hospital discharge, up to 72 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov