An interventional study of Virtual Reality in Oncologic Surgery, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Manitoba · Not applicable, Interventional, and Device feasibility
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.
University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be deemed eligible for inclusion if they: (a) are 18 years of age or older; (b) are able to speak and read English; (c) have received a cancer diagnosis; and (d) are scheduled, or in the process of being scheduled to undergo oncological surgery under general anesthesia at the Health Sciences Centre Winnipeg. Patients will be deemed ineligible if they are unable to provide informed consent (e.g., due to cognitive impairment) or if they have any visual, auditory and/or motor impairments that would preclude effective participation in the Virtual Reality intervention.
Participants assigned to this group will be instructed to review the standardized VR intervention recording daily, following their in-person session and continuing up to their scheduled surgery date.
Device: Virtual Reality
Participants assigned to this group will be instructed to review the standardized VR intervention recording as little or as much as they would like, following their in-person session and continuing up to their scheduled surgery date.
Device: Virtual Reality
The 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.
Engagement
Length of time in minutes participants spent engaging with the virtual reality and each of its components during the in-person session
Time frame: Day 0 post-intervention
Acceptability
The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.
Time frame: Day 0 post-intervention
Anxiety
Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety.
Time frame: Baseline
Depression
Patient Health Questionnaire-8 (PHQ-8). Range 0 to 24, higher score = higher depressive symptoms.
Time frame: Baseline
Pre-Operative Anxiety
Amsterdam Preoperative Anxiety and Information Scale (APAIS). Range 4 - 30 for 6 items.
Time frame: Baseline and re-administered pre-operatively on the day of surgery
Pre-Operative Anxiety
Pre-operative Intrusive Thoughts Inventory (PITI). Range 0 to 60 on 20 items, score \>15 indicative of clinically significant preoperative anxiety.
Time frame: Baseline
Pre-Operative Anxiety
National Comprehensive Cancer Network (NCCN) Anxiety Thermometer. A brief self-report visual analogue scale (VAS) for anxiety. Range 0 to 10, higher score = higher anxiety
Time frame: Baseline and re-administered pre-operatively on the day of surgery.
Pre-Operative Distress
NCCN Distress Thermometer. A brief self-report visual analogue scale (VAS) for anxiety. Range 0 to 10, higher score = higher distress.
Time frame: Baseline and re-administered pre-operatively on the day of surgery
Cybersickness
Simulator Sickness Questionnaire. Range 0-3 for each 16 items, higher score = more severe symptoms.
Time frame: Day 0 post-intervention
Presence
iGroup Presence Questionnaire. Range -3 to +3 for each of 14 items, higher score = higher presence.
Time frame: Day 0 post-intervention
Perceived Usability of Device
System Usability Scale. Range 1 to 5 for each of 10 items, higher score = better usability
Time frame: Day 0 post-intervention
Engagement & Adherence - Standardized Video
Length of time in minutes that the participant engaged with the standardized video, and whether this aligned with the instructions provided.
Time frame: Day 1 up to Day 14
Plan to share: No — Individual participant data will not be shared, consistent with common practice in feasibility studies.
No publications or documents are linked to this record.
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University of Manitoba