Virtual Reality for Pediatric Perioperative Preparation

NCT07650695 | Not Yet Recruiting

• 1 other identifier: 17_26_26.06.2733-GHM
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Preoperative Anxiety; Fear; Pediatric Surgery; Preoperative Care

Keywords

Virtual Reality; Pediatric Surgery; Perioperative Care; children; Nursing intervention; fear; anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Cooperation During Anesthesia Induction

  During anesthesia induction, after transfer to the operating room on the day of surgery.

• Postoperative Pain

  Day of surgery, after return to the hospital room

• Parent Experience and Satisfaction

  At hospital discharge, up to 72 hours after surgery

Study Arms (2)

Virtual Reality Preparation

EXPERIMENTAL

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

Standard Nursing Preparation

ACTIVE COMPARATOR

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

Interventions

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.

Standard Nursing Preparation

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.

Virtual Reality Preparation

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación de investigación HM: lead

Related Publications (3)

• 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.

  PMID: 36700361 RESULT

• 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.

  PMID: 25010821 RESULT

• 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.

  PMID: 21806301 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Cayetana Ruiz Zaldibar, Dr

CONTACT

695829472; crzaldibar@ucjc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and nursing staff delivering the intervention cannot be blinded to group allocation. However, the data analysts responsible for statistical analyses will remain blinded to treatment allocation throughout the study. In addition, the anesthesia nurse assessing induction compliance will not be informed of participant group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel study arms. The intervention arm will receive a virtual reality-based preoperative preparation program (NixiKit) in addition to routine perioperative care, while the control arm will receive the standard preoperative preparation routinely provided by nursing staff. Participants will remain in their assigned group throughout the study, and outcomes will be assessed at predefined perioperative time points.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share