Immersive Virtual Reality Exposure for Reducing Preoperative Anxiety in Children

NCT07018999 | Completed Results

• 2 other identifiers: HKCH-REC-2021-026KCC/RC/G/2223-B05
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety State; Satisfaction; Compliance

Keywords

Virtual reality; perioperative anxiety; children

Outcome Measures

Primary Outcomes (1)

• Modified Yale Preoperative Anxiety Scale (mYPAS) (T1)

  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

  During anaesthesia induction, from entering the operating theatre to successful anaesthesia induction (entered into state of general anaesthesia), usual time frame about 10 to 15 minutes.

Secondary Outcomes (6)

• Baseline Preoperative Anxiety Score Using mYPAS on Admission (T0)

  Preoperative (at ward admission on day of surgery)

• Induction Compliance Checklist

  During anaesthesia induction, from entering the operating theatre to successful anaesthesia induction (entered into state of general anaesthesia), usual time frame about 10 to 15 minutes.

• Procedure Behaviour Rating Scale PBRS

  During anaesthesia induction, from entering the operating theatre to successful anaesthesia induction (entered into state of general anaesthesia), usual time frame about 10 to 15 minutes.

• Parental Anxiety by State-trait Anxiety Inventory (STAI)-T

  during surgery, while parents waiting for children

• Parental Anxiety by State-trait Anxiety Inventory (STAI-S)

  Parent to be completed in waiting room while waiting for participant to complete surgery.

Study Arms (2)

Virtual reality (VR) group

EXPERIMENTAL

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.

Device: Immersive virtual reality operating theatre tour

Control group

NO INTERVENTION

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

Interventions

Immersive virtual reality operating theatre tour 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.

Virtual reality (VR) group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Children's Hospital: lead
• The Hong Kong Polytechnic University: collaborator
• City University of Hong Kong: collaborator

Study Sites (1)

Operating Theatre, Hong Kong Children's Hospital

Hong Kong, Hong Kong

Location

Related Publications (16)

• Moura LA, Dias IM, Pereira LV. Prevalence and factors associated with preoperative anxiety in children aged 5-12 years. Rev Lat Am Enfermagem. 2016 Jun 14;24:e2708. doi: 10.1590/1518-8345.0723.2708.

  PMID: 27305179 BACKGROUND

• Kain ZN, Mayes LC, Wang SM, Caramico LA, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology. 1998 Nov;89(5):1147-56; discussion 9A-10A. doi: 10.1097/00000542-199811000-00015.

  PMID: 9822003 BACKGROUND

• Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.

  PMID: 9322455 BACKGROUND

• Yuan JC, Rodriguez S, Caruso TJ. Unique considerations of virtual reality utilization for perioperative pediatric patients. Paediatr Anaesth. 2021 Mar;31(3):377-378. doi: 10.1111/pan.14108. No abstract available.

  PMID: 33631038 BACKGROUND

• Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.

  PMID: 31136330 BACKGROUND

• Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6.

  PMID: 29317347 BACKGROUND

• Eijlers R, Dierckx B, Staals LM, Berghmans JM, van der Schroeff MP, Strabbing EM, Wijnen RMH, Hillegers MHJ, Legerstee JS, Utens EMWJ. Virtual reality exposure before elective day care surgery to reduce anxiety and pain in children: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):728-737. doi: 10.1097/EJA.0000000000001059.

  PMID: 31356373 BACKGROUND

• Dehghan F, Jalali R, Bashiri H. The effect of virtual reality technology on preoperative anxiety in children: a Solomon four-group randomized clinical trial. Perioper Med (Lond). 2019 Jun 4;8:5. doi: 10.1186/s13741-019-0116-0. eCollection 2019.

  PMID: 31171963 BACKGROUND

• Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.

  PMID: 32618627 BACKGROUND

• Ryu JH, Oh AY, Yoo HJ, Kim JH, Park JW, Han SH. The effect of an immersive virtual reality tour of the operating theater on emergence delirium in children undergoing general anesthesia: A randomized controlled trial. Paediatr Anaesth. 2019 Jan;29(1):98-105. doi: 10.1111/pan.13535. Epub 2018 Nov 25.

  PMID: 30365231 BACKGROUND

• Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.

  PMID: 28975600 BACKGROUND

• Koo CH, Park JW, Ryu JH, Han SH. The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2020 Sep 29;9(10):3151. doi: 10.3390/jcm9103151.

  PMID: 33003411 BACKGROUND

• Pasin L, Febres D, Testa V, Frati E, Borghi G, Landoni G, Zangrillo A. Dexmedetomidine vs midazolam as preanesthetic medication in children: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2015 May;25(5):468-76. doi: 10.1111/pan.12587. Epub 2015 Jan 6.

  PMID: 25559766 BACKGROUND

• Fortier MA, Kain ZN. Treating perioperative anxiety and pain in children: a tailored and innovative approach. Paediatr Anaesth. 2015 Jan;25(1):27-35. doi: 10.1111/pan.12546. Epub 2014 Sep 30.

  PMID: 25266082 BACKGROUND

• Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.

  PMID: 33456927 BACKGROUND

• Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.

  PMID: 16882820 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction; Patient Compliance

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Limitations and Caveats

1. Timing of VR exposure was standardized, and we did not evaluate whether the intervention's effectiveness differs when administered on the same day versus earlier before surgery. 2. Study focused primarily on anxiety reduction and induction compliance, without assessing other important aspects of the patient experience, such as pain perception, satisfaction, or overall healthcare experience from the child's perspective.

Results Point of Contact

• Title: Dr. Vansie Kwok, Consultant
• Organization: Department of Anaesthesiology & Perioperative Medicine, Hong Kong Children's Hospital

kv314@ha.org.hk

+852-96737367

Study Officials

• Vansie Kwok, MBBS, FHKCA

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

  PRINCIPAL INVESTIGATOR

• Richard C Li, MSc, PhD

  Department of Computing, Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 13, 2025
• Study Start: November 17, 2022
• Primary Completion: September 11, 2024
• Study Completion: October 15, 2024
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 1-2 Years of Trial Completion
• Access Criteria: Interested individual will be able to access the IPD by direct e-mail contact with principal investigators.

Locations

HK (1)