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

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 Overview

• Status: Not yet recruiting
• Conditions: Preoperative Anxiety; Fear; Preoperative Care; Pediatric Surgery
• Intervention / Treatment: Device: NixiKit Virtual Reality Preparation; Behavioral: Standard Nursing Preoperative Preparation

Detailed Description

Preoperative anxiety and fear are common among children undergoing elective surgery and may negatively affect cooperation during anesthesia induction, perioperative experience, and postoperative recovery. Educational preparation programs have been developed to help children and their families better understand the surgical process; however, conventional preparation methods may not fully address the emotional needs of pediatric patients.

Virtual reality (VR) has emerged as a promising tool for perioperative preparation by providing immersive and interactive experiences that allow children to become familiar with the hospital environment before surgery. Previous randomized studies and recent systematic reviews have suggested that VR-based preparation may reduce preoperative anxiety and fear while improving cooperation during anesthesia induction and family satisfaction. Nevertheless, evidence remains limited regarding its effectiveness when compared with structured nurse-led preparation delivered as part of routine clinical practice, particularly in real-world hospital settings.

This pilot study aims to evaluate the feasibility and potential effectiveness of a VR-based preoperative preparation program for pediatric patients undergoing elective surgery. The intervention uses the NixiKit system, which provides an immersive virtual tour of the perioperative journey, including the preoperative area, operating room, and recovery room, through age-appropriate audiovisual content designed to familiarize children with the surgical environment.

Participants assigned to the intervention group will receive the VR experience during hospital admission before surgery. Participants assigned to the comparison group will receive the standard preoperative preparation routinely delivered by nursing staff. Data collected during the perioperative period will be used to explore the impact of the intervention on psychological and behavioral outcomes in children as well as on family experience.

As a pilot randomized controlled trial, this study is intended to provide preliminary estimates of intervention effects, assess study procedures and feasibility, and generate information to support the design of a future definitive multicenter trial evaluating virtual reality as a perioperative preparation strategy in pediatric surgical care.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cayetana Ruiz Zaldibar, Dr; Phone Number: 695829472; Email: crzaldibar@ucjc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Preparation; Participants assigned to this arm will receive a virtual reality-based preoperative preparation program using the NixiKit system before elective surgery. The intervention consists of an immersive 360-degree virtual tour of the perioperative pathway, including the preoperative area, operating room, and recovery room, delivered through a virtual reality headset connected to amobile phone. The experience is designed to familiarize children with the surgical environment, reduce fear and anxiety, and improve preparedness for surgery. Participants will also receive routine perioperative care provided by the hospital.	Device: NixiKit Virtual Reality Preparation; 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.
Active Comparator: Standard Nursing Preparation; Participants assigned to this arm will receive the standard preoperative preparation routinely provided by nursing staff before elective surgery. This preparation includes a verbal explanation of the perioperative process, including admission procedures, transfer to the preoperative area, anesthesia induction, the operating room environment, and postoperative recovery. Children and their parents will have the opportunity to ask questions and receive clarification regarding the surgical procedure. Participants will receive routine perioperative care according to hospital practice.	Behavioral: Standard Nursing Preoperative Preparation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery
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.	From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During anesthesia induction, after transfer to the operating room on the day of surgery.
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.	Day of surgery, after return to the hospital room
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.	At hospital discharge, up to 72 hours after surgery

Collaborators and Investigators

• Sponsor: Fundación de investigación HM

Publications and helpful links

General Publications

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
• Franco Castanys T, Jimenez Carrion A, Rodenas Gomez F, Clemente Garcia S, Melero Mascaray A, Janeiro Amela M, Busquets Bonet J. Effects of virtual tour on perioperative pediatric anxiety. Paediatr Anaesth. 2023 May;33(5):377-386. doi: 10.1111/pan.14639. Epub 2023 Feb 7.
• Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Perioperative Care; children; anxiety; Virtual Reality; fear; Pediatric Surgery; Nursing intervention
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 17_26_26.06.2733-GHM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No