Clinical trial NCT07018999: Immersive Virtual Reality Exposure for Reducing Perioperative Anxiety in Children
Official title: Immersive Virtual Reality Exposure for Reducing Perioperative Anxiety in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Satisfaction
Compliance
Keywords: Virtual reality
perioperative anxiety
children
Lead sponsor: Hong Kong Children's Hospital
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
name: City University of Hong Kong
First posted: 2025-06-13
Enrollment: 96
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to intervention group (VR group) and conventional group (Non-VR group). Participants assigned to the VR group will watch the designed VR immersive experience with headset, whereas participants assigned to the non-VR group will receive standard medical care without any additional intervention.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of anxiety of children at induction assessed by modified Yale Preoperative Anxiety Scale (mYPAS)
timeFrame: During anaesthesia induction
Secondary outcomes:
measure: Baseline preoperative anxiety score using mYPAS on admission
timeFrame: Preoperative (at ward admission on day of surgery)
measure: Induction compliance checklist
timeFrame: During anaesthesia induction
measure: Procedure Behaviour Rating Scale PBRS
timeFrame: During anaesthesia induction
measure: Parental anxiety by State-trait anxiety inventory (STAI)
timeFrame: Parent to be completed in waiting room while waiting for participant to complete surgery.
measure: Parental Satisfactory Score
timeFrame: To be completed by parent after anaesthesia and to be submitted to research team on Day 1 post-op.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Operating Theatre, Hong Kong Children's Hospital
Study officials:
affiliation: Department of Anaesthesiology & Perioperative Medicine, Hong Kong Children's Hospital
name: Vansie Kwok, M.B.,B.S, FHKCA, FHKAM (Anaes)
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Computing, Hong Kong Polytechnic University
name: Richard C Li, BSc(Nanjing); MSc, PhD(CityU)
role: PRINCIPAL_INVESTIGATOR
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