Feasibility of a Multimodal Virtual Reality Intervention to Reduce Preoperative Anxiety in Cancer Surgery Patients

University of Manitoba20 enrolled

Overview

The goal of this study is to assess the feasibility of an expanded virtual reality (VR) intervention designed to help prepare patients for cancer surgery. This study will: (1) assess the investigator's ability to recruit, retain, and engage participants, (2) evaluate how acceptable participants find the intervention through their feedback on its individual components. The investigators will also explore whether baseline anxiety levels or psychiatric history predict responses to the intervention, as well as look for any changes in perioperative anxiety and monitoring for any adverse effects associated with the intervention. This study will also investigate engagement of providing participants with a first-person VR session recordings to determine utility and whether post-session access is perceived as beneficial. Finally, preliminary pilot outcomes will examine whether increased engagement in the VR results in reductions in anxiety on the day of surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

SINGLE

Enrollment

Conditions

Oncologic Surgery

Interventions

The VR simulation involves the experience of prepping, waiting, receiving, and recovering from surgery at a large tertiary care centre in Central Canada. It is designed to prepare patients for cancer surgery by increasing familiarity with the hospital environment, providing the opportunity to "experience" restricted areas of the hospital that patients cannot access until the day of the surgery, and better understand the surgical process. The simulation was originally developed for a prior research project focused on breast cancer surgery and has since been adapted based on participant feedback. The intervention includes multiple modules that progress from an orientation to the hospital environment to more immersive, first-person surgical experiences.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Patients will be deemed eligible for inclusion if they: (a) are 18 years of age or older; (b) are able to speak and read English; (c) have received a cancer diagnosis; and (d) are scheduled, or in the process of being scheduled to undergo oncological surgery under general anesthesia at the Health Sciences Centre Winnipeg. Patients will be deemed ineligible if they are unable to provide informed consent (e.g., due to cognitive impairment) or if they have any visual, auditory and/or motor impairments that would preclude effective participation in the Virtual Reality intervention.

Outcomes

Primary Outcomes

Engagement

Length of time in minutes participants spent engaging with the virtual reality and each of its components during the in-person session

Time frame: Day 0 post-intervention

Acceptability

The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.

Time frame: Day 0 post-intervention

Secondary Outcomes

Anxiety

Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety.

Time frame: Baseline

Depression

Patient Health Questionnaire-8 (PHQ-8). Range 0 to 24, higher score = higher depressive symptoms.

Time frame: Baseline

Pre-Operative Anxiety

Amsterdam Preoperative Anxiety and Information Scale (APAIS). Range 4 - 30 for 6 items.

Time frame: Baseline and re-administered pre-operatively on the day of surgery

Pre-Operative Anxiety

Pre-operative Intrusive Thoughts Inventory (PITI). Range 0 to 60 on 20 items, score \>15 indicative of clinically significant preoperative anxiety.

Time frame: Baseline

Pre-Operative Anxiety

National Comprehensive Cancer Network (NCCN) Anxiety Thermometer. A brief self-report visual analogue scale (VAS) for anxiety. Range 0 to 10, higher score = higher anxiety

Time frame: Baseline and re-administered pre-operatively on the day of surgery.

Pre-Operative Distress

NCCN Distress Thermometer. A brief self-report visual analogue scale (VAS) for anxiety. Range 0 to 10, higher score = higher distress.

Time frame: Baseline and re-administered pre-operatively on the day of surgery

Cybersickness

Simulator Sickness Questionnaire. Range 0-3 for each 16 items, higher score = more severe symptoms.

Time frame: Day 0 post-intervention

Presence

iGroup Presence Questionnaire. Range -3 to +3 for each of 14 items, higher score = higher presence.

Time frame: Day 0 post-intervention

Perceived Usability of Device

System Usability Scale. Range 1 to 5 for each of 10 items, higher score = better usability

Time frame: Day 0 post-intervention

Engagement & Adherence - Standardized Video

Length of time in minutes that the participant engaged with the standardized video, and whether this aligned with the instructions provided.

Time frame: Day 1 up to Day 14

Feasibility of a Multimodal Virtual Reality Intervention to Reduce Preoperative Anxiety in Cancer Surgery Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts