VR for Preoperative Anxiety in Children

Virtual Reality for Educating and Reducing Preoperative Anxiety in Children - A Randomised Control Trial

All of the tools currently available for preoperative preparation of children either use a third person approach (i.e., use media whereby they watch a video or look at pictures of another child receiving an anesthetic), provide tours at some time previous to the operation date, or are shown the equipment that they will encounter during their anesthetic. No preoperative programme currently allows the child to experience the entire chain of events from leaving the preoperative preparation area (and their parents), walking to the operating area, being initially prepared for and receiving anesthesia and recovering from anesthesia, in real time and from a first person perspective. As such the investigators are carrying out this study to assess whether virtual reality preoperative preparation is effective in reducing anxiety at induction of anesthesia.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: slideshow; Behavioral: virtual

Detailed Description

The investigators' goal in this study is to investigate the effects of virtual reality preoperative preparation on anxiety in children at induction of anesthesia. The hypothesis is that utilisation of this novel 1st person immersive preparatory method will lead to an enhanced understanding of what will happen to the child (in addition to what the environment looks and sounds like) when they have their anesthetic. The investigators believe this enhanced understanding and preparation will lead to the reduction in anxiety levels before and during the induction of anesthesia, and will also lead to a reduction in postoperative negative behaviour disorders.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged between 6 -18
2. ASA physical status 1-3
3. Admitted for elective surgery (day case and inpatient cases)
4. Cognitively normal

Exclusion Criteria:

1. ASA physical status 4-5
2. Non-English speaking
3. Significant visual and auditory disorders not allowing them to use the technology
4. Epilepsy
5. Mobility problems that would make using the technology difficult or harmful to them (i.e., reduced movement of neck)
6. Cognitive impairment
7. Postoperative PICU care anticipated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: slideshow; Participant receives traditional slideshow presentation for preoperative preparation	Behavioral: slideshow; Participants will be shown a slideshow showing a child being prepared for surgery
OTHER: virtual; Participant receives virtual reality presentation for preoperative preparation	Behavioral: virtual; Participants will be shown an immersive virtual reality preparation for surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety in children	measured using the modified Yale Preoperative Anxiety Scale (mYPAS)	Day of surgery, immediately following consent
Change in child anxiety	measured using the modified Yale Preoperative Anxiety Scale (mYPAS)	Day of surgery, immediately preceding surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction compliance	measured using the Induction Compliance Checklist	Day of surgery, immediately preceding surgery
Anesthetic requirements	measurement includes recording dose of anesthetic(s) used	Day of surgery, intra-operatively
Post-hospitalization negative behaviours	measured using the Posthospitalization Behaviour Questionnaire (PHBQ)	Two to three days after surgery

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Clyde Matava, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2017
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (ACTUAL): June 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1000056779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No