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

Not Applicable

Completed

• Conditions: Anxiety State
• Interventions: Device: Virtual reality operating room simulation

• Registration Number: NCT04544618
• Lead Sponsor: University of Manitoba

Brief 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 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-10
• Study Start: 2021-12-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Virtual reality operating room simulation	Participants will be exposed to a virtual reality simulation of the operating room environment for a minimum of ten minutes.

Primary Outcome Measures

Name	Time	Method
Self-reported impressions of the virtual reality operating room simulation	5 days	Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada