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VR for Preoperative Anxiety in Children

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
slideshow
virtual
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

slideshow

virtual

Arm Description

Participant receives traditional slideshow presentation for preoperative preparation

Participant receives virtual reality presentation for preoperative preparation

Outcomes

Primary Outcome Measures

Anxiety in children
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Change in child anxiety
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

Secondary Outcome Measures

Induction compliance
measured using the Induction Compliance Checklist
Anesthetic requirements
measurement includes recording dose of anesthetic(s) used
Post-hospitalization negative behaviours
measured using the Posthospitalization Behaviour Questionnaire (PHBQ)

Full Information

First Posted
June 26, 2017
Last Updated
December 16, 2021
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT03201640
Brief Title
VR for Preoperative Anxiety in Children
Official Title
Virtual Reality for Educating and Reducing Preoperative Anxiety in Children - A Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
slideshow
Arm Type
Other
Arm Description
Participant receives traditional slideshow presentation for preoperative preparation
Arm Title
virtual
Arm Type
Other
Arm Description
Participant receives virtual reality presentation for preoperative preparation
Intervention Type
Behavioral
Intervention Name(s)
slideshow
Intervention Description
Participants will be shown a slideshow showing a child being prepared for surgery
Intervention Type
Behavioral
Intervention Name(s)
virtual
Intervention Description
Participants will be shown an immersive virtual reality preparation for surgery
Primary Outcome Measure Information:
Title
Anxiety in children
Description
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Time Frame
Day of surgery, immediately following consent
Title
Change in child anxiety
Description
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Time Frame
Day of surgery, immediately preceding surgery
Secondary Outcome Measure Information:
Title
Induction compliance
Description
measured using the Induction Compliance Checklist
Time Frame
Day of surgery, immediately preceding surgery
Title
Anesthetic requirements
Description
measurement includes recording dose of anesthetic(s) used
Time Frame
Day of surgery, intra-operatively
Title
Post-hospitalization negative behaviours
Description
measured using the Posthospitalization Behaviour Questionnaire (PHBQ)
Time Frame
Two to three days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged between 6 -18 ASA physical status 1-3 Admitted for elective surgery (day case and inpatient cases) Cognitively normal Exclusion Criteria: ASA physical status 4-5 Non-English speaking Significant visual and auditory disorders not allowing them to use the technology Epilepsy Mobility problems that would make using the technology difficult or harmful to them (i.e., reduced movement of neck) Cognitive impairment Postoperative PICU care anticipated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clyde Matava
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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VR for Preoperative Anxiety in Children

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