VR for Preoperative Anxiety in Children

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: virtual; Behavioral: slideshow

• Registration Number: NCT03201640
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Study Start: 2017-09-18
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
virtual	virtual	Participant receives virtual reality presentation for preoperative preparation
slideshow	slideshow	Participant receives traditional slideshow presentation for preoperative preparation

Primary Outcome Measures

Name	Time	Method
Change in child anxiety	Day of surgery, immediately preceding surgery	measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Anxiety in children	Day of surgery, immediately following consent	measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

Secondary Outcome Measures

Name	Time	Method
Induction compliance	Day of surgery, immediately preceding surgery	measured using the Induction Compliance Checklist
Anesthetic requirements	Day of surgery, intra-operatively	measurement includes recording dose of anesthetic(s) used
Post-hospitalization negative behaviours	Two to three days after surgery	measured using the Posthospitalization Behaviour Questionnaire (PHBQ)

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada