Oncologic Surgery
Conditions
Keywords
virtual reality, oncological surgery, feasibility, perioperative mental health, preoperative anxiety and distress
Brief summary
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
DEVICEVirtual 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.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Intervention model description
All participants will engage in a single in-person virtual reality session approximately two weeks prior to their surgery. After the session, all participants will be provided with a link to a standardized recorded virtual reality session allowing them to review the intervention experience. Half of the participants will be instructed to watch the video daily, while the other half will be instructed to watch the video at their discretion.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement | Day 0 post-intervention | Length of time in minutes participants spent engaging with the virtual reality and each of its components during the in-person session |
| Acceptability | Day 0 post-intervention | The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Baseline | Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety. |
| Depression | Baseline | Patient Health Questionnaire-8 (PHQ-8). Range 0 to 24, higher score = higher depressive symptoms. |
| Pre-Operative Anxiety | Baseline and re-administered pre-operatively on the day of surgery | Amsterdam Preoperative Anxiety and Information Scale (APAIS). Range 4 - 30 for 6 items. |
| Pre-Operative Distress | Baseline and re-administered pre-operatively on the day of surgery | NCCN Distress Thermometer. A brief self-report visual analogue scale (VAS) for anxiety. Range 0 to 10, higher score = higher distress. |
| Cybersickness | Day 0 post-intervention | Simulator Sickness Questionnaire. Range 0-3 for each 16 items, higher score = more severe symptoms. |
| Presence | Day 0 post-intervention | iGroup Presence Questionnaire. Range -3 to +3 for each of 14 items, higher score = higher presence. |
| Perceived Usability of Device | Day 0 post-intervention | System Usability Scale. Range 1 to 5 for each of 10 items, higher score = better usability |
| Engagement & Adherence - Standardized Video | Day 1 up to Day 14 | Length of time in minutes that the participant engaged with the standardized video, and whether this aligned with the instructions provided. |
Countries
Canada
Contacts
CONTACTCassidy Santos, BA (Hons.)
CONTACTRenee El-Gabalawy, PhD
PRINCIPAL_INVESTIGATORRenee El-Gabalawy, PhD
University of Manitoba
Outcome results
None listed