VR for Preoperative Anxiety in Children

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201640
• Other study ID #: 1000056779
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: December 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• slideshow
Participants will be shown a slideshow showing a child being prepared for surgery
• virtual
Participants will be shown an immersive virtual reality preparation for surgery

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety in children	measured using the modified Yale Preoperative Anxiety Scale (mYPAS)	Day of surgery, immediately following consent
Primary	Change in child anxiety	measured using the modified Yale Preoperative Anxiety Scale (mYPAS)	Day of surgery, immediately preceding surgery
Secondary	Induction compliance	measured using the Induction Compliance Checklist	Day of surgery, immediately preceding surgery
Secondary	Anesthetic requirements	measurement includes recording dose of anesthetic(s) used	Day of surgery, intra-operatively
Secondary	Post-hospitalization negative behaviours	measured using the Posthospitalization Behaviour Questionnaire (PHBQ)	Two to three days after surgery