Trial Outcomes & Findings for Immersive Virtual Reality Exposure for Reducing Preoperative Anxiety in Children (NCT NCT07018999)
NCT ID: NCT07018999
Last Updated: 2025-10-23
Results Overview
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
COMPLETED
NA
114 participants
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.
2025-10-23
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Incomplete data entry
|
4
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Virtual reality (VR) group
n=34 Participants
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.
|
Control group
n=38 Participants
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
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Type of Surgery
Dental
|
5 Participants
n=34 Participants
|
2 Participants
n=38 Participants
|
7 Participants
n=72 Participants
|
|
Type of Surgery
Ear Nose Throat
|
1 Participants
n=34 Participants
|
3 Participants
n=38 Participants
|
4 Participants
n=72 Participants
|
|
Age, Categorical
<=18 years
|
34 Participants
n=34 Participants
|
38 Participants
n=38 Participants
|
72 Participants
n=72 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=34 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=72 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=34 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=72 Participants
|
|
Age, Continuous
|
7.94 years
STANDARD_DEVIATION 2.26 • n=34 Participants
|
8.34 years
STANDARD_DEVIATION 2.02 • n=38 Participants
|
8.16 years
STANDARD_DEVIATION 2.15 • n=72 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=34 Participants
|
4 Participants
n=38 Participants
|
14 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=34 Participants
|
34 Participants
n=38 Participants
|
58 Participants
n=72 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Type of Surgery
General Surgery
|
25 Participants
n=34 Participants
|
30 Participants
n=38 Participants
|
55 Participants
n=72 Participants
|
|
Type of Surgery
Urology
|
2 Participants
n=34 Participants
|
2 Participants
n=38 Participants
|
4 Participants
n=72 Participants
|
|
Type of Surgery
Endocrine
|
0 Participants
n=34 Participants
|
1 Participants
n=38 Participants
|
1 Participants
n=72 Participants
|
|
Type of Surgery
Orthopaedics
|
1 Participants
n=34 Participants
|
0 Participants
n=38 Participants
|
1 Participants
n=72 Participants
|
|
American Society of Anaesthesiologists (ASA) Physical Status Classification
ASA I
|
30 Participants
n=34 Participants
|
30 Participants
n=38 Participants
|
60 Participants
n=72 Participants
|
|
American Society of Anaesthesiologists (ASA) Physical Status Classification
ASA II
|
4 Participants
n=34 Participants
|
8 Participants
n=38 Participants
|
12 Participants
n=72 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Virtual reality (VR) group
n=34 Participants
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.
|
Control group
n=38 Participants
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
|
|---|---|---|
|
Modified Yale Preoperative Anxiety Scale (mYPAS) (T1)
|
31.4 score on a scale
Standard Deviation 8.2
|
37.3 score on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Virtual reality (VR) group
n=34 Participants
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.
|
Control group
n=38 Participants
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
|
|---|---|---|
|
Baseline Preoperative Anxiety Score Using mYPAS on Admission (T0)
|
34.8 score on a scale
Standard Deviation 13.2
|
36.3 score on a scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Virtual reality (VR) group
n=34 Participants
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.
|
Control group
n=38 Participants
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
|
|---|---|---|
|
Induction Compliance Checklist
|
0.824 score on a scale
Standard Deviation 1.03
|
1.13 score on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: 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.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)
Outcome measures
| Measure |
Virtual reality (VR) group
n=34 Participants
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.
|
Control group
n=38 Participants
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
|
|---|---|---|
|
Procedure Behaviour Rating Scale PBRS
|
1.56 score on a scale
Standard Deviation 1.76
|
1.92 score on a scale
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: during 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.
Outcome measures
| Measure |
Virtual reality (VR) group
n=34 Participants
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.
|
Control group
n=38 Participants
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
|
|---|---|---|
|
Parental Anxiety by State-trait Anxiety Inventory (STAI)-T
|
39 score on a scale
Standard Deviation 10
|
41.8 score on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Virtual reality (VR) group
n=34 Participants
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.
|
Control group
n=38 Participants
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
|
|---|---|---|
|
Parental Anxiety by State-trait Anxiety Inventory (STAI-S)
|
39.6 score on a scale
Standard Deviation 11.1
|
43.3 score on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: 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(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.
Outcome measures
| Measure |
Virtual reality (VR) group
n=32 Participants
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.
|
Control group
n=34 Participants
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
|
|---|---|---|
|
Parental Satisfactory Score
|
14.5 score on a scale
Standard Deviation 1.8
|
14.0 score on a scale
Standard Deviation 1.87
|
Adverse Events
Virtual reality (VR) group
Control group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Vansie Kwok, Consultant
Department of Anaesthesiology & Perioperative Medicine, Hong Kong Children's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place