VR for Preoperative Anxiety in Children

NCT03201640 | Completed

• 1 other identifier: 1000056779
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

• Anxiety in children

  measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

  Day of surgery, immediately following consent

• Change in child anxiety

  measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

  Day of surgery, immediately preceding surgery

Secondary Outcomes (3)

• Induction compliance

  Day of surgery, immediately preceding surgery

• Anesthetic requirements

  Day of surgery, intra-operatively

• Post-hospitalization negative behaviours

  Two to three days after surgery

Study Arms (2)

slideshow

OTHER

Participant receives traditional slideshow presentation for preoperative preparation

Behavioral: slideshow

virtual

OTHER

Participant receives virtual reality presentation for preoperative preparation

Behavioral: virtual

Interventions

slideshow BEHAVIORAL

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

slideshow

virtual BEHAVIORAL

Participants will be shown an immersive virtual reality preparation for surgery

virtual

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged between 6 -18
• ASA physical status 1-3
• Admitted for elective surgery (day case and inpatient cases)
• Cognitively normal

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Clyde Matava

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: September 18, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)