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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Anxiety State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

Participants will be exposed to a virtual reality simulation of the operating room environment for a minimum of ten minutes.

Group Type EXPERIMENTAL

Virtual reality operating room simulation

Intervention Type DEVICE

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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No