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| ID | Type | Description | Link |
|---|---|---|---|
| 322523 340300 2000 | Other Grant/Funding Number | New Frontiers |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants will be exposed to a virtual reality simulation of the operating room environment for a minimum of ten minutes. |
|
| Treatment as usual group | No Intervention | Participants will receive standard of care with no additional intervention aside from information received at their surgical oncology appointment and optional preoperative education classes (available to all patients). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality operating room simulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported impressions of the virtual reality operating room simulation | Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention | Baseline |
| Self-reported impressions of the virtual reality operating room simulation | Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| NCCN Distress Thermometer | VAS self-reported distress on a scale of 0-10 | Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days |
| NCCN Anxiety Thermometer | VAS self-reported anxiety on a scale of 0-10 |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS emotional distress- anxiety | PROMIS anxiety questionnaire | Baseline, 5 days, and 30 days |
| PROMIS emotional distress- depression | PROMIS depression questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordana Sommer, MA | University of Manitoba | Principal Investigator |
| Renée El-Gabalawy, PhD | University of Manitoba | Principal Investigator |
| Kristin Reynolds, PhD | University of Manitoba | Study Director |
| Pamela Hebbard, MD | University of Manitoba | Study Director |
| Natalie Mota, PhD | University of Manitoba | Study Director |
| Alan Mutch, MD | University of Manitoba | Study Director |
| Thomas Mutter, MD | University of Manitoba | Study Director |
| Rakesh Arora, MD | University of Manitoba | Study Director |
| Jessica Maples-Keller, PhD | Emory University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre | Winnipeg | Manitoba | R3E 3N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42024710 | Derived | El-Gabalawy R, Logan GS, Hebbard P, Sommer JL, Reynolds K, Penner KE, Smith MSD, Mota N, Mutch WAC, Mollanji E, Maples-Keller JL, Perrin D, Arora RC. An Interactive Preoperative Virtual Reality Intervention for Breast Cancer Patients Undergoing Oncological Surgery: A Feasibility and Pilot Randomized Clinical Trial. J Surg Oncol. 2026 Apr 23. doi: 10.1002/jso.70269. Online ahead of print. | |
| 38743939 |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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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).
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| Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days |
| iGroup Presence Questionnaire | Assessing the sense of presence experienced by participants in the virtual environment | Immediately after the intervention |
| Preoperative Intrusive Thoughts Inventory (PITI) | PITI questionnaire | Baseline and up to 2 weeks after baseline on day of scheduled surgery |
| Amsterdam Preoperative Anxiety Information Scale (APAIS) | APAIS questionnaire | Baseline and up to 2 weeks after baseline on day of scheduled surgery |
| Baseline, 5 days, and 30 days |
| PROMIS global health | PROMIS global health questionnaire | Baseline, 5 days, and 30 days |
| PROMIS fatigue | PROMIS fatigue questionnaire | Baseline, 5 days, and 30 days |
| PROMIS emotional support | PROMIS emotional support questionnaire | Baseline, 5 days, and 30 days |
| PROMIS pain intensity | PROMIS pain intensity questionnaire | 5 days and 30 days |
| Peritraumatic Distress Inventory (PDI) | PDI questionnaire | Baseline and 5 days |
| Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) | PC-PTSD-5 questionnaire | Baseline and 30 days |
| Brief Resilient Coping Scale (BRCS) | BRCS questionnaire | Baseline, 5 days, and 30 days |
| Derived |
| El-Gabalawy R, Sommer JL, Hebbard P, Reynolds K, Logan GS, Smith MSD, Mutter TC, Mutch WA, Mota N, Proulx C, Gagnon Shaigetz V, Maples-Keller JL, Arora RC, Perrin D, Benedictson J, Jacobsohn E. An Immersive Virtual Reality Intervention for Preoperative Anxiety and Distress Among Adults Undergoing Oncological Surgery: Protocol for a 3-Phase Development and Feasibility Trial. JMIR Res Protoc. 2024 May 14;13:e55692. doi: 10.2196/55692. |
| 38231570 | Derived | Sommer JL, Reynolds K, Hebbard P, Smith MSD, Mota N, Mutch WAC, Maples-Keller J, Roos L, El-Gabalawy R. Preoperative Virtual Reality to Expose Patients With Breast Cancer to the Operating Room Environment: Feasibility and Pilot Case Series Study. JMIR Form Res. 2024 Jan 17;8:e46367. doi: 10.2196/46367. |