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Completed

NCT Number: NCT03201640

VR for Preoperative Anxiety in Children

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

slideshow

Behavioral

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

virtual

Behavioral

Participants will be shown an immersive virtual reality preparation for surgery

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2017
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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