Feasibility of a Multimodal Virtual Reality Intervention to Reduce Preoperative Anxiety in Cancer Surgery Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Oncologic Surgery
• Intervention / Treatment: Device: Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassidy Santos, BA (Hons.); Phone Number: 204-787-7424; Email: csantos17@hsc.mb.ca
• Study Contact Backup: Name: Renee El-Gabalawy, PhD; Phone Number: 204-787-4083; Email: renee.el-gabalawy@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0Z2
      • Recruiting
      • Health Sciences Centre
      • Contact: Renee El-Gabalawy, PhD; Phone Number: 204-787-4083; Email: renee.el-gabalawy@umanitoba.ca
      • Contact: Cassidy Santos, BA (Hons.); Phone Number: 204-787-7242; Email: csantos17@hsc.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Daily Viewing Group; 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; 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.
Other: Self-directed group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement	Length of time in minutes participants spent engaging with the virtual reality and each of its components during the in-person session	Day 0 post-intervention
Acceptability	The Theoretical Framework of Acceptability Questionnaire (TFAQ score > 3 indicates acceptability). Range 1-5 on seven items.	Day 0 post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety.	Baseline
Depression	Patient Health Questionnaire-8 (PHQ-8). Range 0 to 24, higher score = higher depressive symptoms.	Baseline
Pre-Operative Anxiety	Amsterdam Preoperative Anxiety and Information Scale (APAIS). Range 4 - 30 for 6 items.	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.	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	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.	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.	Day 0 post-intervention
Presence	iGroup Presence Questionnaire. Range -3 to +3 for each of 14 items, higher score = higher presence.	Day 0 post-intervention
Perceived Usability of Device	System Usability Scale. Range 1 to 5 for each of 10 items, higher score = better usability	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.	Day 1 up to Day 14

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Renee El-Gabalawy, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: feasibility; virtual reality; oncological surgery; perioperative mental health; preoperative anxiety and distress
• Other Study ID Numbers: 0414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared, consistent with common practice in feasibility studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No