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VR for Preoperative Anxiety in Children

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Completed
CT.gov ID
NCT03201640
Collaborator
(none)
39
Enrollment
1
Location
2
Arms
19.4
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: slideshow
  • Behavioral: virtual
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
Virtual Reality for Educating and Reducing Preoperative Anxiety in Children - A Randomised Control Trial
Actual Study Start Date :
Sep 18, 2017
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Anxiety in children [Day of surgery, immediately following consent]

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

  2. Change in child anxiety [Day of surgery, immediately preceding surgery]

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

Secondary Outcome Measures

  1. Induction compliance [Day of surgery, immediately preceding surgery]

    measured using the Induction Compliance Checklist

  2. Anesthetic requirements [Day of surgery, intra-operatively]

    measurement includes recording dose of anesthetic(s) used

  3. Post-hospitalization negative behaviours [Two to three days after surgery]

    measured using the Posthospitalization Behaviour Questionnaire (PHBQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clyde Matava, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT03201640
Other Study ID Numbers:
  • 1000056779
First Posted:
Jun 28, 2017
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Dec 17, 2021