Virtual Reality for Pediatric Perioperative Preparation

Official title

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

Overview

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.

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.

Interventions

• 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 design
• 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.

Primary outcome measures

• Change in Preoperative Anxiety [Time frame: 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 [Time frame: 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 (3)

• Cooperation During Anesthesia Induction [Time frame: During anesthesia induction, after transfer to the operating room on the day of surgery.]
• Postoperative Pain [Time frame: Day of surgery, after return to the hospital room]
• Parent Experience and Satisfaction [Time frame: At hospital discharge, up to 72 hours after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT07650695 · 17_26_26.06.2733-GHM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗