Anxiety State
Conditions
Keywords
Preoperative anxiety, Cancer, Virtual reality, Feasibility, Pilot study
Brief summary
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
Interventions
DEVICEVirtual reality operating room simulation
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.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported impressions of the virtual reality operating room simulation | Baseline | Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NCCN Distress Thermometer | Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days | VAS self-reported distress on a scale of 0-10 |
| NCCN Anxiety Thermometer | Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days | VAS self-reported anxiety on a scale of 0-10 |
| iGroup Presence Questionnaire | Immediately after the intervention | Assessing the sense of presence experienced by participants in the virtual environment |
| Preoperative Intrusive Thoughts Inventory (PITI) | Baseline and up to 2 weeks after baseline on day of scheduled surgery | PITI questionnaire |
| Amsterdam Preoperative Anxiety Information Scale (APAIS) | Baseline and up to 2 weeks after baseline on day of scheduled surgery | APAIS questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Peritraumatic Distress Inventory (PDI) | Baseline and 5 days | PDI questionnaire |
| PROMIS emotional distress- anxiety | Baseline, 5 days, and 30 days | PROMIS anxiety questionnaire |
| Brief Resilient Coping Scale (BRCS) | Baseline, 5 days, and 30 days | BRCS questionnaire |
| Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) | Baseline and 30 days | PC-PTSD-5 questionnaire |
| PROMIS emotional distress- depression | Baseline, 5 days, and 30 days | PROMIS depression questionnaire |
| PROMIS global health | Baseline, 5 days, and 30 days | PROMIS global health questionnaire |
| PROMIS fatigue | Baseline, 5 days, and 30 days | PROMIS fatigue questionnaire |
| PROMIS emotional support | Baseline, 5 days, and 30 days | PROMIS emotional support questionnaire |
| PROMIS pain intensity | 5 days and 30 days | PROMIS pain intensity questionnaire |
Countries
Canada
Outcome results
None listed