NCT02998801

Brief Summary

To construct and evaluate an immersive 3D simulation to familiarize patients with the pre-operative experience, and investigate whether A) immersive 3D virtual reality video can reduce pre-operative anxiety, and B) how this approach compares to current practice of viewing traditional educational videos.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2017

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

November 21, 2016

Last Update Submit

April 4, 2017

Conditions

Virtual RealityAnxietyPreoperative Anxiety

Outcome Measures

Primary Outcomes (1)

  • Change in anxiety levels as measured using VAS score from baseline to the day of surgery inside the OR.

    2 weeks

Secondary Outcomes (2)

  • Change in heart rate between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.

    2 weeks

  • Change in blood pressure between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.

    2 weeks

Study Arms (2)

Watch video using IPAD

PLACEBO COMPARATOR

Patient will watch the educational video using an IPAD

Other: IPAD

Watch video using VR goggles

ACTIVE COMPARATOR

Patient will watch the educational video using VR goggles

Other: VR Goggles

Interventions

IPADOTHER

Patients undergoing surgery will watch the video using an PAD

Watch video using IPAD
VR GogglesOTHER

Patients undergoing surgery will watch the video using goggles

Watch video using VR goggles

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants less than 80 years old presenting to the pre-assessment clinic at Sunnybrook Health Sciences Centre
  • Planned surgical procedure is 7-14 days after pre-assessment clinic visit

You may not qualify if:

  • Inability to provide informed consent
  • Unable to complete study assessments (ie: visually impaired)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Fahad Alam, MD, FRCPC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

December 20, 2016

Study Start

November 1, 2016

Primary Completion

March 20, 2017

Study Completion

March 20, 2017

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

CA(1)