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VR for Preoperative Anxiety in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201640
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Clyde Matava, The Hospital for Sick Children

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
Anxiety Behavioral: slideshow Behavioral: virtual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 18, 2017
Actual Primary Completion Date : April 30, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
slideshow
Participant receives traditional slideshow presentation for preoperative preparation
Behavioral: slideshow
Participants will be shown a slideshow showing a child being prepared for surgery

virtual
Participant receives virtual reality presentation for preoperative preparation
Behavioral: virtual
Participants will be shown an immersive virtual reality preparation for surgery




Primary Outcome Measures :
  1. Anxiety in children [ Time Frame: Day of surgery, immediately following consent ]
    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

  2. Change in child anxiety [ Time Frame: Day of surgery, immediately preceding surgery ]
    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)


Secondary Outcome Measures :
  1. Induction compliance [ Time Frame: Day of surgery, immediately preceding surgery ]
    measured using the Induction Compliance Checklist

  2. Anesthetic requirements [ Time Frame: Day of surgery, intra-operatively ]
    measurement includes recording dose of anesthetic(s) used

  3. Post-hospitalization negative behaviours [ Time Frame: Two to three days after surgery ]
    measured using the Posthospitalization Behaviour Questionnaire (PHBQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201640


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Clyde Matava The Hospital for Sick Children
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Responsible Party: Clyde Matava, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03201640    
Other Study ID Numbers: 1000056779
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders