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

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: Completed
• Conditions: Anxiety State
• Intervention / Treatment: Device: Virtual reality operating room simulation

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordana Sommer, MA; Phone Number: (204)787-4713; Email: sommerj@myumanitoba.ca
• 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	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	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NCCN Distress Thermometer	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	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	Assessing the sense of presence experienced by participants in the virtual environment	Immediately after the intervention
Preoperative Intrusive Thoughts Inventory (PITI)	PITI questionnaire	Baseline and up to 2 weeks after baseline on day of scheduled surgery
Amsterdam Preoperative Anxiety Information Scale (APAIS)	APAIS questionnaire	Baseline and up to 2 weeks after baseline on day of scheduled surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS emotional distress- anxiety	PROMIS anxiety questionnaire	Baseline, 5 days, and 30 days
PROMIS emotional distress- depression	PROMIS depression questionnaire	Baseline, 5 days, and 30 days
PROMIS global health	PROMIS global health questionnaire	Baseline, 5 days, and 30 days
PROMIS fatigue	PROMIS fatigue questionnaire	Baseline, 5 days, and 30 days
PROMIS emotional support	PROMIS emotional support questionnaire	Baseline, 5 days, and 30 days
PROMIS pain intensity	PROMIS pain intensity questionnaire	5 days and 30 days
Peritraumatic Distress Inventory (PDI)	PDI questionnaire	Baseline and 5 days
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)	PC-PTSD-5 questionnaire	Baseline and 30 days
Brief Resilient Coping Scale (BRCS)	BRCS questionnaire	Baseline, 5 days, and 30 days

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Jordana Sommer, MA, University of Manitoba; Principal Investigator: Renée 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

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Feasibility; Virtual reality; Pilot study; Preoperative anxiety
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID 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