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NCT Number: NCT07366515

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.

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Key information

Conditions

Oncologic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Engagement

    Time frame: 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

  2. Acceptability

    Time frame: Day 0 post-intervention

    The Theoretical Framework of Acceptability Questionnaire (TFAQ score > 3 indicates acceptability). Range 1-5 on seven items.

Secondary outcomes

  1. Anxiety

    Time frame: Baseline

    Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety.

  2. Depression

    Time frame: Baseline

    Patient Health Questionnaire-8 (PHQ-8). Range 0 to 24, higher score = higher depressive symptoms.

  3. Pre-Operative Anxiety

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

    Amsterdam Preoperative Anxiety and Information Scale (APAIS). Range 4 - 30 for 6 items.

  4. Pre-Operative Anxiety

    Time frame: Baseline

    Pre-operative Intrusive Thoughts Inventory (PITI). Range 0 to 60 on 20 items, score >15 indicative of clinically significant preoperative anxiety.

  5. Pre-Operative Anxiety

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

    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

  6. Pre-Operative Distress

    Time frame: 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.

  7. Cybersickness

    Time frame: Day 0 post-intervention

    Simulator Sickness Questionnaire. Range 0-3 for each 16 items, higher score = more severe symptoms.

  8. Presence

    Time frame: Day 0 post-intervention

    iGroup Presence Questionnaire. Range -3 to +3 for each of 14 items, higher score = higher presence.

  9. Perceived Usability of Device

    Time frame: Day 0 post-intervention

    System Usability Scale. Range 1 to 5 for each of 10 items, higher score = better usability

  10. Engagement & Adherence - Standardized Video

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cassidy Santos, BA (Hons.)

CONTACT

[email protected]

204-787-7424

Renee El-Gabalawy, PhD

CONTACT

[email protected]

204-787-4083

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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