Evaluation of a Pre-surgical Virtual Reality Simulation for Cancer Surgery Patients

February 16, 2024 updated by: Jordana Sommer, University of Manitoba

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Gabrielle S Logan, MSc
  • Phone Number: 204-787-4713
  • Email: glogan@hsc.mb.ca

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3N4
        • Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Treatment as usual group
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).
Experimental: Intervention group
Participants will be exposed to a virtual reality simulation of the operating room environment for a minimum of ten minutes.
Device: Virtual reality operating room simulation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline
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 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NCCN Distress Thermometer
Time Frame: Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days
VAS self-reported distress on a scale of 0-10
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
VAS self-reported anxiety on a scale of 0-10
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
Assessing the sense of presence experienced by participants in the virtual environment
Immediately after the intervention
Preoperative Intrusive Thoughts Inventory (PITI)
Time Frame: Baseline and up to 2 weeks after baseline on day of scheduled surgery
PITI questionnaire
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
APAIS questionnaire
Baseline and up to 2 weeks after baseline on day of scheduled surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS emotional distress- anxiety
Time Frame: Baseline, 5 days, and 30 days
PROMIS anxiety questionnaire
Baseline, 5 days, and 30 days
PROMIS emotional distress- depression
Time Frame: Baseline, 5 days, and 30 days
PROMIS depression questionnaire
Baseline, 5 days, and 30 days
PROMIS global health
Time Frame: Baseline, 5 days, and 30 days
PROMIS global health questionnaire
Baseline, 5 days, and 30 days
PROMIS fatigue
Time Frame: Baseline, 5 days, and 30 days
PROMIS fatigue questionnaire
Baseline, 5 days, and 30 days
PROMIS emotional support
Time Frame: Baseline, 5 days, and 30 days
PROMIS emotional support questionnaire
Baseline, 5 days, and 30 days
PROMIS pain intensity
Time Frame: 5 days and 30 days
PROMIS pain intensity questionnaire
5 days and 30 days
Peritraumatic Distress Inventory (PDI)
Time Frame: Baseline and 5 days
PDI questionnaire
Baseline and 5 days
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
Time Frame: Baseline and 30 days
PC-PTSD-5 questionnaire
Baseline and 30 days
Brief Resilient Coping Scale (BRCS)
Time Frame: Baseline, 5 days, and 30 days
BRCS questionnaire
Baseline, 5 days, and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jordana Sommer, MA, University of Manitoba
  • Principal Investigator: Renee El-Gabalawy, PhD, University of Manitoba
  • Study Director: Kristin Reynolds, PhD, University of Manitoba
  • Study Director: Pamela Hebbard, MD, University of Manitoba
  • Study Director: Natalie Mota, PhD, University of Manitoba
  • Study Director: Alan Mutch, MD, University of Manitoba
  • Study Director: Thomas Mutter, MD, University of Manitoba
  • Study Director: Rakesh Arora, MD, University of Manitoba
  • Study Director: Jessica Maples-Keller, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS23957 (H2020:247)
  • 322523 340300 2000 (Other Grant/Funding Number: New Frontiers)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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