- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06393556
VR for the Reduction of Perioperative Anxiety
Assessment and Minimization of Preoperative Fear of the Unknown Using a VR Experience of the Theatre Suite; a Randomized Control Trial
The study, set to take place at Gold Coast University Hospital in Australia, will be conducted as a randomized controlled trial. Patients preparing for gynecological cancer surgery will be recruited and randomly assigned to one of two groups: those who will receive standard care plus a virtual reality (VR) intervention, and those who will receive only standard care. Standard care encompasses the usual pre-operative procedures and support provided by the hospital staff.
We hypothesize that immersing patients in a preparatory virtual environment that shows them what they are to expect during their upcoming hospital stay for surgery, could help reduce their anxiety levels.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study objective is to determine whether exposure to the operating theatre suite via virtual reality (VR) for patients undergoing gynecologic-oncological surgery reduces pre-operative anxiety.
After patients are recruited, their anxiety level is measured by a simple 6-item visual anxiety scale (T0). Patients are then randomized into either receiving care-as-usual (CAU), or CAU combined with a VR experience (~3.5 minutes; with background music and narration) where they are familiarized with the environment they will encounter during their stay for their cancer operation. Anxiety is measured again (T1). Days/weeks later, when patients are back in the hospital for their surgery (T2), anxiety is measured again in the preanesthetic bay, before receiving any anesthetics. Personnel collecting the anxiety scale at T2 will be unaware whether a patient had received the VR intervention or not.
Randomization will be performed by a person unrelated to the study by using a computerized randomization tool to generate an allocation list and inserting paper slips with the group allocation into consecutively numbered, opaque envelopes which are opened, in order, at the time of randomization.
Using a two-sided Wilcoxon-Mann-Whitney test and targeting a power of 80% at a significance level α of 0.05, abd assuming a clinically relevant difference in the anxiety scale of at least one "face" (i.e. at least 1 point on the 6-item scale) between the two groups and a within-group standard deviation of 1.6 (effect size: 0.625), sample size was determined as 34 patients per group for a 1:1 group allocation. Assuming a drop out/lost-to-follow up rate of up to 15%, 80 patients (40 per group) are to be recruited.
Descriptive statistic analysis will be performed. Within-group and between-group assessements will be done using Wilcoxon signed rank test and the Mann-Whitney rank sum test, respectively.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Queensland
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Southport, Queensland, Australia, 4215
- Gold Coast University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Gynecological oncology patients with scheduled surgery
Exclusion Criteria:
- Language barrier
- Inability to provide consent
- Having undergone any procedure at the operating theatre in the previous 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual reality
Care-as-usual + virtual reality intervention during a pre-operative visit
|
An immersive VR experience, delivered using a VR head-mounted display, of the real-world environment at the hospital, featuring the pre-operative admission suite, pre-anesthetic bay, operating theatre, postoperative recovery room, and medical staff.
|
No Intervention: Control
Care-as-usual during a pre-operative visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: T0 (before randomization), T1 (same day as T0, but after care as usual +/- VR; usually inside 1 hour), T2 (days/weeks later, before surgical procedure - exact gap is unknown; expected: >3 days, median around 4-7 weeks)
|
Anxiety level measured by a 6-item visual scale (1 .. least anxiety, 6 ... highest anxiety)
|
T0 (before randomization), T1 (same day as T0, but after care as usual +/- VR; usually inside 1 hour), T2 (days/weeks later, before surgical procedure - exact gap is unknown; expected: >3 days, median around 4-7 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bernd C Schmid, MD, Gold Coast University Hospital
Publications and helpful links
General Publications
- Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.
- Schmid BC, Marsland D, Jacobs E, Rezniczek GA. A Preparatory Virtual Reality Experience Reduces Anxiety before Surgery in Gynecologic Oncology Patients: A Randomized Controlled Trial. Cancers (Basel). 2024 May 17;16(10):1913. doi: 10.3390/cancers16101913.
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 (Actual)
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
- VRPERIOP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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