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VR for Preoperative Anxiety in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03201640
Enrollment
39
Registered
2017-06-28
Start date
2017-09-18
Completion date
2019-04-30
Last updated
2021-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

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.

Interventions

BEHAVIORALslideshow

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

BEHAVIORALvirtual

Participants will be shown an immersive virtual reality preparation for surgery

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety in childrenDay of surgery, immediately following consentmeasured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Change in child anxietyDay of surgery, immediately preceding surgerymeasured using the modified Yale Preoperative Anxiety Scale (mYPAS)

Secondary

MeasureTime frameDescription
Induction complianceDay of surgery, immediately preceding surgerymeasured using the Induction Compliance Checklist
Anesthetic requirementsDay of surgery, intra-operativelymeasurement includes recording dose of anesthetic(s) used
Post-hospitalization negative behavioursTwo to three days after surgerymeasured using the Posthospitalization Behaviour Questionnaire (PHBQ)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026