- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02998801
Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality (VR-Anxiety)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Watch video using IPAD
Patient will watch the educational video using an IPAD
|
Patients undergoing surgery will watch the video using an PAD
|
ACTIVE_COMPARATOR: Watch video using VR goggles
Patient will watch the educational video using VR goggles
|
Patients undergoing surgery will watch the video using goggles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in anxiety levels as measured using VAS score from baseline to the day of surgery inside the OR.
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 weeks
|
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
|
2 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 484-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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