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Immersive Virtual Reality Exposure for Reducing Preoperative Anxiety in Children

Immersive Virtual Reality Exposure for Reducing Preoperative Anxiety in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07018999
Enrollment
114
Registered
2025-06-13
Start date
2022-11-17
Completion date
2024-10-15
Last updated
2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety State, Compliance, Satisfaction

Keywords

Virtual reality, perioperative anxiety, children

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.

Interventions

DEVICEImmersive 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.

Sponsors

The Hong Kong Polytechnic University
CollaboratorOTHER
City University of Hong Kong
CollaboratorOTHER
Hong Kong Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Yale Preoperative Anxiety Scale (mYPAS) (T1)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.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

MeasureTime frameDescription
Induction Compliance ChecklistDuring 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.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. Score range from 0 to 10. Total maximum score is 10. High score indicates reduction in compliance to anaesthesia induction procedures.
Procedure Behaviour Rating Scale PBRSDuring 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.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 (Score range 0-25)
Baseline Preoperative Anxiety Score Using mYPAS on Admission (T0)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.
Parental Anxiety by State-trait Anxiety Inventory (STAI-S)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: 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) measures temporary, situational anxiety (how a person feels right now). STAI 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. Score ranged from 20-80 with higher score indicating increasing current (state) anxiety. Traditional Chinese validated version will be given to Chinese speaking parents.
Parental Satisfactory ScoreTo 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(1), not satisfied(2), satisfied(3), very satisfied(4)) 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? The total score is calculated as the sum of all items, range from minimum 4 to maximum 16. Higher score indicating higher satisfaction.
Parental Anxiety by State-trait Anxiety Inventory (STAI)-Tduring surgery, while parents waiting for childrenValidated 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: Trait Anxiety (STAI-T) measures a person's general tendency toward anxiety (how a person typically feels). STAI 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. Total score ranged from 20-80 with higher score indicating more anxiety-prone personality (trait anxiety) Traditional Chinese validated version will be given to Chinese speaking parents.

Countries

Hong Kong

Participant flow

Recruitment details

Participant recruitment took place during pre-anaesthetic assessment at the Hong Kong Children's Hospital pre-anaesthetic clinic between November 2022 to June 2024. The first patient was enrolled on 17 November 2022 and the last patient was enrolled on 5 June 2024. Of 114 participants enrolled, 84 met criteria and were randomized to treatment. The first patient assessment was on 3 January 2023. The last patient completed assessment 11 September 2024.

Pre-assignment details

After patient enrollment, 30 of them dropped out before randomization due to surgery cancellation (n=10) , change of surgical plan (n=12), advancement or delay of surgery date resulting in children either too young or too mature for inclusion (n=4), or unavailability of researchers on surgery date (n=4).

Participants by arm

ArmCount
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. 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.
34
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
38
Total72

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyIncomplete data entry47
Overall StudyProtocol Violation01

Baseline characteristics

CharacteristicVirtual reality (VR) groupControl groupTotal
Age, Categorical
<=18 years
34 Participants38 Participants72 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous7.94 years
STANDARD_DEVIATION 2.26
8.34 years
STANDARD_DEVIATION 2.02
8.16 years
STANDARD_DEVIATION 2.15
American Society of Anaesthesiologists (ASA) Physical Status Classification
ASA I
30 Participants30 Participants60 Participants
American Society of Anaesthesiologists (ASA) Physical Status Classification
ASA II
4 Participants8 Participants12 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
10 Participants4 Participants14 Participants
Sex: Female, Male
Male
24 Participants34 Participants58 Participants
Type of Surgery
Dental
5 Participants2 Participants7 Participants
Type of Surgery
Ear Nose Throat
1 Participants3 Participants4 Participants
Type of Surgery
Endocrine
0 Participants1 Participants1 Participants
Type of Surgery
General Surgery
25 Participants30 Participants55 Participants
Type of Surgery
Orthopaedics
1 Participants0 Participants1 Participants
Type of Surgery
Urology
2 Participants2 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 42
other
Total, other adverse events
0 / 420 / 42
serious
Total, serious adverse events
0 / 420 / 42

Outcome results

Primary

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

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Virtual reality (VR) groupModified Yale Preoperative Anxiety Scale (mYPAS) (T1)31.4 score on a scaleStandard Deviation 8.2
Control groupModified Yale Preoperative Anxiety Scale (mYPAS) (T1)37.3 score on a scaleStandard Deviation 14.5
Secondary

Baseline Preoperative Anxiety Score Using mYPAS on Admission (T0)

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.

Time frame: Preoperative (at ward admission on day of surgery)

ArmMeasureValue (MEAN)Dispersion
Virtual reality (VR) groupBaseline Preoperative Anxiety Score Using mYPAS on Admission (T0)34.8 score on a scaleStandard Deviation 13.2
Control groupBaseline Preoperative Anxiety Score Using mYPAS on Admission (T0)36.3 score on a scaleStandard Deviation 17.3
Secondary

Induction Compliance Checklist

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. Score range from 0 to 10. Total maximum score is 10. High score indicates reduction in compliance to anaesthesia induction procedures.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Virtual reality (VR) groupInduction Compliance Checklist0.824 score on a scaleStandard Deviation 1.03
Control groupInduction Compliance Checklist1.13 score on a scaleStandard Deviation 1.55
Secondary

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

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: 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) measures temporary, situational anxiety (how a person feels right now). STAI 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. Score ranged from 20-80 with higher score indicating increasing current (state) anxiety. Traditional Chinese validated version will be given to Chinese speaking parents.

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

ArmMeasureValue (MEAN)Dispersion
Virtual reality (VR) groupParental Anxiety by State-trait Anxiety Inventory (STAI-S)39.6 score on a scaleStandard Deviation 11.1
Control groupParental Anxiety by State-trait Anxiety Inventory (STAI-S)43.3 score on a scaleStandard Deviation 9.3
Secondary

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

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: Trait Anxiety (STAI-T) measures a person's general tendency toward anxiety (how a person typically feels). STAI 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. Total score ranged from 20-80 with higher score indicating more anxiety-prone personality (trait anxiety) Traditional Chinese validated version will be given to Chinese speaking parents.

Time frame: during surgery, while parents waiting for children

ArmMeasureValue (MEAN)Dispersion
Virtual reality (VR) groupParental Anxiety by State-trait Anxiety Inventory (STAI)-T39 score on a scaleStandard Deviation 10
Control groupParental Anxiety by State-trait Anxiety Inventory (STAI)-T41.8 score on a scaleStandard Deviation 8.2
Secondary

Parental Satisfactory Score

Standard form to be given to every parent after general anaesthesia, with four-point scale (very unsatisfied(1), not satisfied(2), satisfied(3), very satisfied(4)) 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? The total score is calculated as the sum of all items, range from minimum 4 to maximum 16. Higher score indicating higher satisfaction.

Time frame: To be completed by parent after anaesthesia and to be submitted to research team on Day 1 post-op.

ArmMeasureValue (MEAN)Dispersion
Virtual reality (VR) groupParental Satisfactory Score14.5 score on a scaleStandard Deviation 1.8
Control groupParental Satisfactory Score14.0 score on a scaleStandard Deviation 1.87
Secondary

Procedure Behaviour Rating Scale PBRS

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 (Score range 0-25)

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Virtual reality (VR) groupProcedure Behaviour Rating Scale PBRS1.56 score on a scaleStandard Deviation 1.76
Control groupProcedure Behaviour Rating Scale PBRS1.92 score on a scaleStandard Deviation 2.08

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026