Immersive Virtual Reality Exposure for Reducing Preoperative Anxiety in Children

NCT ID: NCT07018999

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2024-10-15

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.

Conditions

Anxiety State; Satisfaction; Compliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Virtual reality (VR) group

Participants assigned to the VR group will watch the designed VR immersive experience with headset on the day of surgery on top of the usual interventions as received in the control group.

Group Type: EXPERIMENTAL

Immersive virtual reality operating theatre tour

Intervention Type: DEVICE

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 participants. A simulation of the perioperative journey in HKCH operating theatre will be created to help participants form realistic expectations of their perioperative journey, and virtual exposure of different medical equipment helps participants 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 participants see in VR.

Control group

All recruited participants will receive standard medical care and provided with information regarding the perioperative journey as per usual practice, including watching an introductory video in the waiting room area with accompanying adults, receiving perioperative education by a pre-anaesthetic nurse, as well as having an opportunity to have any questions answered by an anaesthesiologist in the pre-anaesthetic assessment clinic. They will not receive Virtual Reality intervention before surgery on surgery day

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Immersive virtual reality operating theatre tour

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 participants. A simulation of the perioperative journey in HKCH operating theatre will be created to help participants form realistic expectations of their perioperative journey, and virtual exposure of different medical equipment helps participants 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 participants see in VR.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: collaborator

City University of Hong Kong

OTHER

Sponsor Role: collaborator

Hong Kong Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

KWOK, Vansie

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vansie Kwok, MBBS, FHKCA

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology & Perioperative Medicine, Hong Kong Children's Hospital

Richard C Li, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Computing, Hong Kong Polytechnic University

Locations

Operating Theatre, Hong Kong Children's Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

KCC/RC/G/2223-B05

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HKCH-REC-2021-026

Identifier Type: -

Identifier Source: org_study_id