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Virtual Reality Simulation for Preoperative Anxiety
N/A
Waitlist Available
Led By Renée El-Gabalawy, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days and 30 days
Awards & highlights
Study Summary
This trial will test if a virtual reality simulation of an operating room can reduce preoperative anxiety and distress in breast cancer patients.
Who is the study for?
This trial is for English-speaking adults over 18 who are scheduled for cancer surgery under general anesthesia at the Health Sciences Centre in Winnipeg. Participants must have a cancer diagnosis and be able to engage with virtual reality. It's not suitable for those with visual/auditory impairments or cognitive issues preventing informed consent.Check my eligibility
What is being tested?
The study tests a virtual reality simulation of an operating room designed to reduce anxiety in patients before cancer surgery. It will assess how well recruitment, data collection, and the VR intervention work, comparing it with usual treatment methods.See study design
What are the potential side effects?
Since this intervention involves virtual reality, potential side effects may include temporary discomfort like dizziness, nausea, or eye strain from using the VR headset.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Self-reported impressions of the virtual reality operating room simulation
Secondary outcome measures
Amsterdam Preoperative Anxiety Information Scale (APAIS)
NCCN Anxiety Thermometer
NCCN Distress Thermometer
+2 moreOther outcome measures
Brief Resilient Coping Scale (BRCS)
PROMIS emotional distress- anxiety
PROMIS emotional distress- depression
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Participants will be exposed to a virtual reality simulation of the operating room environment for a minimum of ten minutes.
Group II: Treatment as usual groupActive Control1 Intervention
Participants will receive standard of care with no additional intervention aside from information received at their surgical oncology appointment and optional preoperative education classes (available to all patients).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual reality operating room simulation
2021
N/A
~30
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Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,499 Total Patients Enrolled
9 Trials studying Anxiety
604 Patients Enrolled for Anxiety
Renée El-Gabalawy, PhDPrincipal InvestigatorUniversity of Manitoba
Kristin Reynolds, PhDStudy DirectorUniversity of Manitoba
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can't take part in a virtual reality treatment because of problems with your vision or hearing.You have been diagnosed with cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Treatment as usual group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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