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VR for Preoperative Anxiety in Children

NCT ID: NCT03201640

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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slideshow

Participant receives traditional slideshow presentation for preoperative preparation

Group Type OTHER

slideshow

Intervention Type BEHAVIORAL

Participants will be shown a slideshow showing a child being prepared for surgery

virtual

Participant receives virtual reality presentation for preoperative preparation

Group Type OTHER

virtual

Intervention Type BEHAVIORAL

Participants will be shown an immersive virtual reality preparation for surgery

Interventions

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slideshow

Participants will be shown a slideshow showing a child being prepared for surgery

Intervention Type BEHAVIORAL

virtual

Participants will be shown an immersive virtual reality preparation for surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Clyde Matava

Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clyde Matava

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000056779

Identifier Type: -

Identifier Source: org_study_id