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Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality (VR-Anxiety)

Primary Purpose

Virtual Reality, Anxiety, Preoperative Anxiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
IPAD
VR Goggles
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Virtual Reality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Watch video using IPAD

Watch video using VR goggles

Arm Description

Patient will watch the educational video using an IPAD

Patient will watch the educational video using VR goggles

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 21, 2016
Last Updated
April 4, 2017
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02998801
Brief Title
Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality
Acronym
VR-Anxiety
Official Title
Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 20, 2017 (Actual)
Study Completion Date
March 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The prevalence of pre-operative anxiety is estimated as being as high as 80% in surgical populations. Physiologically, this may result in higher cortisol levels, which may slow down the healing and recovery process. A multitude of perioperative clinical trials have revealed that pre-operative anxiety is associated with reduced short-term postoperative recovery, increased pain scores, nause & vomiting, sleep disturbances, surgical wound infections, increased length of stay, and cardiac complications. It has also been linked with worse functional outcomes and quality of life up to one-year after surgery. Literature looking at factors associated with preoperative anxiety outline a general theme of the fear of the unknown that is distressing. Specifically, the most distressing events seem to be waiting to be collected for surgery, waiting outside the operating room (OR), being transferred to the OR bed and having monitors and oxygen mask applied. These moments prior to surgery are when patients are most likely to continuously ruminate over 'what comes next' and the fact of not knowing - leading to anxiety. One survey of 161 patients presenting for elective surgery inquired about factors that led to being calm prior to their procedure and found that being well informed of the pre-operative process was a critical aspect of anxiety relief. Approaches such as implementation of the pre-anesthetic clinic (PAC) and the use of videos of what to expect leading up to surgery have been implemented to address this issue but have been costly or have had mixed effects. Virtual reality (VR) technology presents a new educational opportunity for patients in an effort to reduce pre-operative anxiety. Through immersive 3D simulation, patients can experience the journey of being prepped for surgery and transferred to the OR. A patient can learn about their pre-operative experience in a more engaging manner as opposed to passively reading, watching video or being verbally taught about it by the healthcare provider. A patient is educated by having the perception of being physically present in the pre-operative experience days or weeks prior to their OR date.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Anxiety, Preoperative Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Watch video using IPAD
Arm Type
Placebo Comparator
Arm Description
Patient will watch the educational video using an IPAD
Arm Title
Watch video using VR goggles
Arm Type
Active Comparator
Arm Description
Patient will watch the educational video using VR goggles
Intervention Type
Other
Intervention Name(s)
IPAD
Intervention Description
Patients undergoing surgery will watch the video using an PAD
Intervention Type
Other
Intervention Name(s)
VR Goggles
Intervention Description
Patients undergoing surgery will watch the video using goggles
Primary Outcome Measure Information:
Title
Change in anxiety levels as measured using VAS score from baseline to the day of surgery inside the OR.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in heart rate between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.
Time Frame
2 weeks
Title
Change in blood pressure between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Inability to provide informed consent Unable to complete study assessments (ie: visually impaired)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahad Alam, MD, FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality

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