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

NCT07366515 | Recruiting

• 1 other identifier: 0414
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncologic Surgery

Keywords

virtual reality; oncological surgery; feasibility; perioperative mental health; preoperative anxiety and distress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Anxiety

  Baseline

• Depression

  Baseline

• Pre-Operative Anxiety

  Baseline and re-administered pre-operatively on the day of surgery

• Pre-Operative Anxiety

  Baseline

• Pre-Operative Anxiety

  Baseline and re-administered pre-operatively on the day of surgery.

Study Arms (2)

Daily Viewing Group

OTHER

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

Self-directed group

OTHER

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

Interventions

Virtual Reality DEVICE

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.

Daily Viewing Group; Self-directed group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3E 0Z2, Canada

RECRUITING

Study Officials

• Renee El-Gabalawy, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassidy Santos, BA (Hons.)

CONTACT

204-787-7424; csantos17@hsc.mb.ca

Renee El-Gabalawy, PhD

CONTACT

204-787-4083; renee.el-gabalawy@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 26, 2026
• Study Start: April 22, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)