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

NCT04544618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-02-20

No results posted yet for this study

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

Conditions

  • Anxiety State

Interventions

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.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Jordana Sommer, MA · University of Manitoba

  • Renée El-Gabalawy, PhD · University of Manitoba

  • Kristin Reynolds, PhD · University of Manitoba

  • Pamela Hebbard, MD · University of Manitoba

  • Natalie Mota, PhD · University of Manitoba

  • Alan Mutch, MD · University of Manitoba

  • Thomas Mutter, MD · University of Manitoba

  • Rakesh Arora, MD · University of Manitoba

  • Jessica Maples-Keller, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04544618 on ClinicalTrials.gov