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Oncologic SurgeryNCT07366515

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

A study testing Virtual Reality in people with Oncologic Surgery, run by University of Manitoba at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oncologic Surgery
What is being tested?
Virtual Reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
22 Apr 2026to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Canada1 site, 1 recruiting

  • Health Sciences Centre

    Winnipeg, Manitoba, R3E 0Z2

    Cassidy Santos, BA (Hons.), 204-787-7242, csantos17@hsc.mb.ca

    Renee El-Gabalawy, PhD, 204-787-4083, renee.el-gabalawy@umanitoba.ca

    Recruiting

Other trials in Canada

About this study

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.

Being tested
Virtual Reality
Keywords
virtual reality, oncological surgery, feasibility, perioperative mental health, preoperative anxiety and distress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityDevice

    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.

Study groups in NCT07366515
Study groupRoleWhat they receive
Daily Viewing GroupOtherParticipants 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.
Receives: Device: Virtual Reality
Self-directed groupOtherParticipants 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.
Receives: Device: Virtual Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Engagement

    Length of time in minutes participants spent engaging with the virtual reality and each of its components during the in-person session

    Measured: Day 0 post-intervention

  2. Acceptability

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

    Measured: Day 0 post-intervention

Secondary outcomes (10)

  1. Anxiety

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

    Measured: Baseline

  2. Depression

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

    Measured: Baseline

  3. Pre-Operative Anxiety

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

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

  4. Pre-Operative Anxiety

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

    Measured: Baseline

  5. 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

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

  6. Pre-Operative Distress

    NCCN Distress Thermometer. A brief self-report visual analogue scale (VAS) for anxiety. Range 0 to 10, higher score = higher distress.

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

  7. Cybersickness

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

    Measured: Day 0 post-intervention

  8. Presence

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

    Measured: Day 0 post-intervention

  9. Perceived Usability of Device

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

    Measured: Day 0 post-intervention

  10. 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.

    Measured: Day 1 up to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start22 Apr 2026
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07366515
Sponsor's protocol ID
0414
Status last verified
Dec 2025
First submitted
10 Dec 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared, consistent with common practice in feasibility studies.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality in people with Oncologic Surgery, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cassidy Santos, BA (Hons.) (204-787-7424, csantos17@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Engagement (time frame: Day 0 post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07366515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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