Immersive Virtual Reality Exposure for Reducing Perioperative Anxiety in Children

Not Applicable

Completed

• Conditions: Anxiety State; Satisfaction; Compliance

• Registration Number: NCT07018999
• Lead Sponsor: Hong Kong Children's Hospital

Brief Summary

Perioperative anxiety management for children undergoing surgery poses a major challenge to anaesthesiologists as high anxiety, reported in numerous studies, leads to detrimental effects physiologically, mentally and on pain scores. Traditional methods, including administration of anxiolytics pre-op has its own limitations e.g. side effects of drugs. Non-pharmacological approaches e.g. OT orientation or information have a heavy reliance on manpower. A sustainable and reliable non-pharmacological method that requires minimal manpower support is needed for the effective management of paediatric perioperative anxiety.

Virtual reality utilises a head-mounted display with visual, auditory and tactile stimuli to simulate a fully immersive 3-dimensional environment. Its application in the paediatric perioperative setting can be either as a distraction during painful procedures or during induction of anaesthesia or as an exposure tool in preoperative education and has demonstrated success in literature.

In a joint project involving the Department of Computing of Hong Kong Polytechnic University, the Department of Computer Science Center for Innovative Applications of Internet and Multimedia Technologies of the City University of Hong Kong and the Hong Kong Children's Hospital (HKCH), an immersive VR operating theatre tour will be designed as part of preoperative education for children. A simulation of the perioperative journey in HKCH operating theatre will be created to help children form realistic expectations of their perioperative journey to cope with their worries about the anticipated procedures.

Detailed Description

Undergoing an operation is a major stress for both children and their families, with up to 50% of the children reported to have significant perioperative anxiety . High levels of perioperative anxiety in children manifest as tension, irritability and increased autonomic nervous system activity; and are associated with a multitude of adverse clinical outcomes, including increased postoperative analgesia requirement, increased postoperative emergence delirium, increased postoperative behavioural changes (e.g. nightmares, postoperative separation and general anxiety, eating problems that can persist up to 2 weeks after surgery). Furthermore, it impacts patient and parental satisfaction, creating an overall negative experience for families and staff.

The multifaceted risk factors of perioperative anxiety in children warrant a multi-modal array of tools up anaesthesiologists' sleeves to tailor for different children's needs based on age, understanding of instructions, and temperament . While pharmacological anxiolytics, e.g. Dexmedetomidine and Midazolam, are commonly deployed and effective, it has its limitations, such as time to effect, patient's age, as well as paradoxical agitation reported up to 10% for Midazolam, as well as taking away a learning opportunity for children to cope with stress. Common non-pharmacological approaches include parental presence during induction of anaesthesia, distraction techniques, and educational approaches.

Traditional educational approaches often involve providing information to children and parents/legal guardians by written pamphlets, either physical or video tour of the operating room, recovery area, and orientation of medical equipment. With the advance of technology, children are often familiar and easily engaged with technological devices, including smart phones, tablets, video games, and even immersive virtual reality (VR). VR is increasingly utilized in clinical setting, providing a fun and engaging educational experience for children.

VR utilizes a head-mounted display with visual, auditory and tactile stimuli to simulate a fully immersive 3-dimensional environment. Its application in the paediatric perioperative setting can be either as distraction during painful procedures or during induction of anaesthesia, or as an exposure tool in preoperative education. A meta-analysis of the effect of VR on preoperative anxiety shows a significant reduction of preoperative anxiety in paediatric patients. Previous study utilized a famous cartoon character in the VR preoperative educational video and showed significant reduction in preoperative anxiety when compared to children receiving information through conventional means. This benefit of VR exposure in reducing preoperative anxiety is not only evident in numerous studies measuring anxiety score, but also demonstrated in studies measuring salivary cortisol concentration.

In a joint project involving the Department of Computing of Hong Kong Polytechnic University, the Department of Computer science Center for Innovative Applications of Internet and Multimedia Technologies of the City University of Hong Kong and the Hong Kong Children's Hospital (HKCH), an immersive VR operating theatre tour will be designed as part of preoperative education for children. A simulation of the perioperative journey in HKCH operating theatre will be created to help children form realistic expectations of their perioperative journey, and virtual exposure of different medical equipment helps children cope with their worries for the anticipated procedures. Parents/legal guardians will be able to monitor the VR experience on tablets via the monitoring software, which displays what the children see in VR. Given the fact that the capacity of conventional approaches, e.g. child-play involvement by child-life specialists are hugely limited now due to COVID pandemic, such a VR-enabled approach may help to alleviate patient's anxiety.

Study Timeline

• Study Start: 2023-01-03
• Primary Completion: 2024-09-11
• Study Completion: 2024-10-15
• Study First Submitted: 2025-05-28
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• American Society of Anaesthesiologist (ASA) physical status I or II
• Undergo elective surgical procedures which requires general anaesthesia
• No previous experience of anaesthesia or surgery

Exclusion Criteria

• Patients who are undergoing ultra-major surgery requiring postoperative intensive care unit care.
• Patients who are blind, or with hearing impairment
• Patients with significant developmental or cognitive delays, ADHD or autism
• Patients with history or current symptoms of vertigo
• Patients with history of epilepsy or seizures
• Patients who require anxiolytic premedication
• Patients who have physical conditions that prohibit use of headsets e.g. head / facial injuries, open skin or infectious condition on head/face, head/ facial malformation that precludes proper fitting of the VR headset
• Non-Cantonese speaking patients (due to limited resources of having Cantonese speaking VR design)
• Patients and/or parents/legal guardians who refuse to participate in study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of anxiety of children at induction assessed by modified Yale Preoperative Anxiety Scale (mYPAS)	During anaesthesia induction	Primary outcome is whether there is a significant reduction of anxiety of children at induction, defined by a 20% change in the modified Yale Preoperative Anxiety Scale (mYPAS) between control group and intervention group at anaesthesia induction T1.; mYPAS is considered the gold standard in assessing preoperative anxiety in children , consisting of 27 items divided into five domains: activity, emotional expressivity, state of arousal, vocalization and use of parents/legal guardians. The score ranges from minimum 23.3 to 100. A cut-off of \>/= 30 indicates a high anxiety level in children. Higher score indicates increasing preoperative anxiety.; This instrument has been considered as a gold standard instrument for measuring preoperative anxiety and had been administered in many previous studies. mYPAS will be assessed by a blinded researcher or anaesthesiologist, at induction in the operating theatre

Secondary Outcome Measures

Name	Time	Method
Baseline preoperative anxiety score using mYPAS on admission	Preoperative (at ward admission on day of surgery)	After admission on the day of surgery, mYPAS assessment to be conducted preoperatively before randomization by a blinded researcher. mYPAS score (as stated in primary outcome measure description above) ranges from minimum 23.3 to 100. A cut-off of \>/= 30 indicates a high anxiety level in children. Higher score indicates increasing preoperative anxiety.
Induction compliance checklist	During anaesthesia induction	Score of checklist previously quoted in other literature that measures behaviours during anaesthesia induction, assessed by blinded observer. Items include crying, turning head away from mask, verbal refusal, verbalization of fear or worry, pushes mask away with hands/pushes nurse away, covers mouth/nose, hysterical crying, kicking/arching back, requires physical restraint, complete passivity. Total maximum score is 10. High score indicates reduction in compliance to anaesthesia induction procedures.
Procedure Behaviour Rating Scale PBRS	During anaesthesia induction	Observational tool developed by Melamed and colleagues (specifically Barbara G. Melamed and her team) in the 1970s-1980s as part of research on behavioral distress during medical procedures, particularly in pediatric populations. It is used to assess a patient's behavior during medical or dental procedures, particularly in contexts where anxiety, distress, or uncooperative behavior may arise.; Domains Assessed: Common behaviors rated include: * Verbal resistance (crying, complaining).; * Physical resistance (pulling away, flailing).; * Facial expressions (grimacing, clenched teeth).; * Cooperation level (following instructions, remaining still).; Scoring: * Typically uses a Likert scale (e.g., 1-5) or categorical ratings (e.g., "none," "mild," "severe").; * Higher scores indicate greater distress or noncompliance.; * Maximum total score = 25
Parental anxiety by State-trait anxiety inventory (STAI)	Parent to be completed in waiting room while waiting for participant to complete surgery.	Validated psychological assessment tool designed to measure anxiety in adults. Developed by Charles Spielberger, Richard Gorsuch, and Robert Lushene in 1970, it distinguishes between two types of anxiety: State Anxiety (STAI-S) - Temporary, situational anxiety (how a person feels right now).; Trait Anxiety (STAI-T) - A person's general tendency toward anxiety (how a person typically feels).; Including 40-item self-report questionnaire (20 items for state anxiety, 20 for trait anxiety).; Scoring: Likert scale (1 to 4), with higher scores indicating higher anxiety levels.; Traditional Chinese validated version will be given to Chinese speaking parents.
Parental Satisfactory Score	To be completed by parent after anaesthesia and to be submitted to research team on Day 1 post-op.	Standard form to be given to every parent after general anaesthesia, with four-point scale (very unsatisfied, not satisfied, satisfied, very satisfied) to 4 questions including; * Are you satisfied with our preadmission service? (Pre-anaesthetic assessment/Pre-anaesthesia clinic); * Are you satisfied with our preoperative instructions?; * Are you satisfied with the operating theatre service?; * Are you satisfied with postoperative service?

Trial Locations

Locations (1)

Operating Theatre, Hong Kong Children's Hospital; 🇭🇰 Hong Kong, Hong Kong