About this trial
The goal of this study is to assess the feasibility of an expanded virtual reality (VR) intervention designed to help prepare patients for cancer surgery. This study will: (1) assess the investigator's ability to recruit, retain, and engage participants, (2) evaluate how acceptable participants find the intervention through their feedback on its individual components. The investigators will also explore whether baseline anxiety levels or psychiatric history predict responses to the intervention, as well as look for any changes in perioperative anxiety and monitoring for any adverse effects associated with the intervention. This study will also investigate engagement of providing participants with a first-person VR session recordings to determine utility and whether post-session access is perceived as beneficial. Finally, preliminary pilot outcomes will examine whether increased engagement in the VR results in reductions in anxiety on the day of surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Virtual Reality
DeviceThe VR simulation involves the experience of prepping, waiting, receiving, and recovering from surgery at a large tertiary care centre in Central Canada. It is designed to prepare patients for cancer surgery by increasing familiarity with the hospital environment, providing the opportunity to "experience" restricted areas of the hospital that patients cannot access until the day of the surgery, and better understand the surgical process. The simulation was originally developed for a prior research project focused on breast cancer surgery and has since been adapted based on participant feedback. The intervention includes multiple modules that progress from an orientation to the hospital environment to more immersive, first-person surgical experiences.
Treatment groups
Trial outcomes
Primary outcomes
Engagement
Length of time in minutes participants spent engaging with the virtual reality and each of its components during the in-person session
Acceptability
The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.
Secondary outcomes
Anxiety
Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety.
Depression
Patient Health Questionnaire-8 (PHQ-8). Range 0 to 24, higher score = higher depressive symptoms.
Pre-Operative Anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS). Range 4 - 30 for 6 items.
Pre-Operative Anxiety
Pre-operative Intrusive Thoughts Inventory (PITI). Range 0 to 60 on 20 items, score \>15 indicative of clinically significant preoperative anxiety.
Sponsors and contacts
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