Anxiety StateNCT04544618
Evaluation of a Pre-surgical Virtual Reality Simulation for Cancer Surgery Patients
A study testing Virtual reality operating room simulation in people with Anxiety State, run by University of Manitoba at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety State
- What is being tested?
- Virtual reality operating room simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2021to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Over the age of 18
- Can speak and read English
- Has a cancer diagnosis
- Scheduled/being scheduled to undergo cancer surgery under general anesthesia at the Health Sciences Centre (Winnipeg, MB)
Who cannot join
- Those who do not meet any inclusion criteria
- Those who are not competent to provide informed consent (e.g., due to cognitive impairment)
- Those who are unable to participate in a virtual reality intervention (e.g., due to visual/auditory impairment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Virtual Reality for Cancer Surgery Patients: A Feasibility and Pilot Study
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
- Conditions
- Anxiety State
- Being tested
- Virtual reality operating room simulation
- Keywords
- Preoperative anxiety, Cancer, Virtual reality, Feasibility, Pilot study
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality operating room simulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will be exposed to a virtual reality simulation of the operating room environment for a minimum of ten minutes. Receives: Device: Virtual reality operating room simulation |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 days
Secondary outcomes (5)
NCCN Distress Thermometer
VAS self-reported distress on a scale of 0-10
Measured: 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
Measured: 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
Measured: Immediately after the intervention
Preoperative Intrusive Thoughts Inventory (PITI)
PITI questionnaire
Measured: Baseline and up to 2 weeks after baseline on day of scheduled surgery
Amsterdam Preoperative Anxiety Information Scale (APAIS)
APAIS questionnaire
Measured: Baseline and up to 2 weeks after baseline on day of scheduled surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Dec 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordana Sommer, University of Manitoba
- Investigators
- Jordana Sommer, MA, Principal investigator, University of ManitobaRenée El-Gabalawy, PhD, Principal investigator, University of ManitobaKristin Reynolds, PhD, Study director, University of ManitobaPamela Hebbard, MD, Study director, University of ManitobaNatalie Mota, PhD, Study director, University of ManitobaAlan Mutch, MD, Study director, University of ManitobaThomas Mutter, MD, Study director, University of ManitobaRakesh Arora, MD, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544618
- Sponsor's protocol ID
- HS23957 (H2020:247)
- Other IDs
- 322523 340300 2000
- Status last verified
- Feb 2024
- First submitted
- 19 Aug 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Jul;134(1):5-15. doi: 10.1002/jso.70269. Epub 2026 Apr 23.
PubMed 42024710El-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.
PubMed 38743939Sommer 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.
PubMed 38231570
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Virtual Reality for Cancer Surgery Patients: A Feasibility and Pilot Study
- ClinicalTrials.gov ID
- NCT04544618
- Acronym / sponsor ID
- HS23957 (H2020:247)
- Conditions
- Anxiety State
- Keywords
- Preoperative anxiety, Cancer, Virtual reality, Feasibility, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Virtual reality operating room simulationParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over the age of 18
- Can speak and read English
- Has a cancer diagnosis
- Scheduled/being scheduled to undergo cancer surgery under general anesthesia at the Health Sciences Centre (Winnipeg, MB)
Key exclusion criteria (3 listed)
- Those who do not meet any inclusion criteria
- Those who are not competent to provide informed consent (e.g., due to cognitive impairment)
- Those who are unable to participate in a virtual reality intervention (e.g., due to visual/auditory impairment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality operating room simulationThe 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. | Device | Intervention group |
Primary outcome
Self-reported impressions of the virtual reality operating room simulation
Time frame: Baseline
Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention
Self-reported impressions of the virtual reality operating room simulation
Time frame: 5 days
Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention
5 secondary outcomes
NCCN Distress Thermometer
Time frame: Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days
NCCN Anxiety Thermometer
Time frame: Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days
iGroup Presence Questionnaire
Time frame: Immediately after the intervention
Preoperative Intrusive Thoughts Inventory (PITI)
Time frame: Baseline and up to 2 weeks after baseline on day of scheduled surgery
Amsterdam Preoperative Anxiety Information Scale (APAIS)
Time frame: Baseline and up to 2 weeks after baseline on day of scheduled surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 42024710El-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 Jul;134(1):5-15. doi: 10.1002/jso.70269. Epub 2026 Apr 23.
- Derived from this study: PubMed 38743939El-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.
- Derived from this study: PubMed 38231570Sommer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordana Sommer, MA principal investigator
University of Manitoba
Renée El-Gabalawy, PhD principal investigator
University of Manitoba
Kristin Reynolds, PhD study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality operating room simulation in people with Anxiety State, 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?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 20 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported impressions of the virtual reality operating room simulation (time frame: Baseline). 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 NCT04544618, which also lists 3 linked publications.
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 20 Feb 2024.