Feasibility of a Multimodal Virtual Reality Intervention to Reduce Preoperative Anxiety in Cancer Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality.
- Who it may be relevant to
- Registry conditions: Oncologic Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 resear
Primary outcome measures
- Engagement [Time frame: Day 0 post-intervention]
- Acceptability [Time frame: Day 0 post-intervention]
Secondary outcome measures (10)
- Anxiety [Time frame: Baseline]
- Depression [Time frame: Baseline]
- Pre-Operative Anxiety [Time frame: Baseline and re-administered pre-operatively on the day of surgery]
- Pre-Operative Anxiety [Time frame: Baseline]
- Pre-Operative Anxiety [Time frame: Baseline and re-administered pre-operatively on the day of surgery.]
- Pre-Operative Distress [Time frame: Baseline and re-administered pre-operatively on the day of surgery]
- Cybersickness [Time frame: Day 0 post-intervention]
- Presence [Time frame: Day 0 post-intervention]
- Perceived Usability of Device [Time frame: Day 0 post-intervention]
- Engagement & Adherence - Standardized Video [Time frame: Day 1 up to Day 14]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Device feasibility
Study locations
Canada · 1 center
- Health Sciences Centre — Winnipeg
Identifiers
NCT: NCT07366515 · 0414