Evaluation of a Pre-surgical Virtual Reality Simulation for Cancer Surgery Patients

Study Overview
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Brief Summary
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This study will pilot test and explore the feasibility of a virtual reality simulation of the operating room environment to reduce anxiety/distress in cancer surgery patients. Study objectives are to evaluate recruitment and data collection procedures, outcome measures, participant feedback on the virtual reality operating room intervention, and the inclusion of a treatment as usual group, and effects of the intervention on symptoms of anxiety/distress. Results of this study will inform the design of an upcoming larger-scale RCT to assess the efficacy of this intervention

Official Title
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Preoperative Virtual Reality for Cancer Surgery Patients: A Feasibility and Pilot Study

Conditions
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Anxiety State

Intervention / Treatment
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* Device: Virtual reality operating room simulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 18 Can speak and read English Has a cancer diagnosis Scheduled/being scheduled to undergo cancer surgery under general anesthesia at the Health Sciences Centre (Winnipeg, MB) Exclusion Criteria: Those who do not meet any inclusion criteria Those who are not competent to provide informed consent (e.g., due to cognitive impairment) Those who are unable to participate in a virtual reality intervention (e.g., due to visual/auditory impairment)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will employ a single-blind randomized design (1:1 randomization; stratified according to surgery type [with vs. without reconstruction] and whether or not neoadjuvant chemotherapy was received; stratification will designate equal proportions of participants with these characteristics across each of the two study groups).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will be exposed to a virtual reality simulation of the operating room environment for a minimum of ten minutes. | Device: Virtual reality operating room simulation<br>* The virtual reality simulation will begin with the participant sitting on a hospital bed wearing the virtual reality headset and holding the controllers. Participants will be oriented to the environment and provided with an explanation of how to navigate through the simulation (for approximately 2 minutes). Next, participants will explore the virtual operating room for a minimum of 5 minutes, or longer if desired. Following the exploration period, the scripted portion of the simulation will be begin. Here, participants will be taken through the mock anesthetic induction process (the virtual anesthetist will speak to the patient and walk them through the steps and the virtual nurse will assist). The simulation ends after the virtual oxygen mask is placed over the participant's mouth and the screen darkens.<br>|
| No Intervention: Treatment as usual group<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported impressions of the virtual reality operating room simulation | Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention | Baseline | 
| Self-reported impressions of the virtual reality operating room simulation | Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCCN Distress Thermometer | VAS self-reported distress on a scale of 0-10 | Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days | 
| NCCN Anxiety Thermometer | VAS self-reported anxiety on a scale of 0-10 | Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days | 
| iGroup Presence Questionnaire | Assessing the sense of presence experienced by participants in the virtual environment | Immediately after the intervention | 
| Preoperative Intrusive Thoughts Inventory (PITI) | PITI questionnaire | Baseline and up to 2 weeks after baseline on day of scheduled surgery | 
| Amsterdam Preoperative Anxiety Information Scale (APAIS) | APAIS questionnaire | Baseline and up to 2 weeks after baseline on day of scheduled surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative anxiety, Cancer, Virtual reality, Feasibility, Pilot study