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

Sponsor

University of Manitoba (Other)

Overall Status

Recruiting

CT.gov ID

NCT04544618

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will pilot test and explore the feasibility of a virtual reality simulation of the operating room environment to reduce preoperative anxiety/distress in breast cancer patients. Study objectives are to evaluate recruitment and data collection procedures, outcome measures, participant feedback on the virtual reality operating room intervention, inclusion of a control intervention and treatment as usual group, and effects of the active intervention on symptoms of preoperative anxiety/distress.

Condition or Disease	Intervention/Treatment	Phase
Anxiety State	Device: Virtual reality operating room simulation Device: Non-surgery-related virtual reality simulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study will employ a single-blind randomized design (1:1:1 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 three study groups).This study will employ a single-blind randomized design (1:1:1 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 three study groups).

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Preoperative Virtual Reality for Breast Cancer Surgery Patients: A Feasibility and Pilot Study

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active 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.
Placebo Comparator: Control intervention group Participants will explore a non-surgery related virtual reality simulation, pre-programmed to the virtual reality headset for a minimum of ten minutes.	Device: Non-surgery-related virtual reality simulation Participants will explore a non-surgery-related virtual reality simulation (e.g., Google Earth simulation) pre-programmed to the virtual reality headset.
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).

Arm

Intervention/Treatment

Experimental: Active 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.

Placebo Comparator: Control intervention group

Participants will explore a non-surgery related virtual reality simulation, pre-programmed to the virtual reality headset for a minimum of ten minutes.

Device: Non-surgery-related virtual reality simulation

Participants will explore a non-surgery-related virtual reality simulation (e.g., Google Earth simulation) pre-programmed to the virtual reality headset.

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).

Outcome Measures

Primary Outcome Measures

Self-reported impressions of the virtual reality operating room simulation [Immediately after the intervention]
Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Over the age of 18
Can speak and read English
Has a breast cancer diagnosis
Scheduled/being scheduled to undergo breast 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)