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

NCT04544618 | Completed

• 2 other identifiers: HS23957 (H2020:247)322523 340300 2000
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety State

Keywords

Preoperative anxiety; Cancer; Virtual reality; Feasibility; Pilot study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• NCCN Distress Thermometer

  Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days

• NCCN Anxiety Thermometer

  Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days

• iGroup Presence Questionnaire

  Immediately after the intervention

• Preoperative Intrusive Thoughts Inventory (PITI)

  Baseline and up to 2 weeks after baseline on day of scheduled surgery

• Amsterdam Preoperative Anxiety Information Scale (APAIS)

  Baseline and up to 2 weeks after baseline on day of scheduled surgery

Other Outcomes (9)

• PROMIS emotional distress- anxiety

  Baseline, 5 days, and 30 days

• PROMIS emotional distress- depression

  Baseline, 5 days, and 30 days

• PROMIS global health

  Baseline, 5 days, and 30 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Treatment as usual group

NO INTERVENTION

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).

Interventions

Virtual reality operating room simulation DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3E 3N4, Canada

Location

Related Publications (2)

• El-Gabalawy R, Sommer JL, Hebbard P, Reynolds K, Logan GS, Smith MSD, Mutter TC, Mutch WA, Mota N, Proulx C, Gagnon Shaigetz V, Maples-Keller JL, Arora RC, Perrin D, Benedictson J, Jacobsohn E. An Immersive Virtual Reality Intervention for Preoperative Anxiety and Distress Among Adults Undergoing Oncological Surgery: Protocol for a 3-Phase Development and Feasibility Trial. JMIR Res Protoc. 2024 May 14;13:e55692. doi: 10.2196/55692.

  PMID: 38743939 DERIVED

• Sommer JL, Reynolds K, Hebbard P, Smith MSD, Mota N, Mutch WAC, Maples-Keller J, Roos L, El-Gabalawy R. Preoperative Virtual Reality to Expose Patients With Breast Cancer to the Operating Room Environment: Feasibility and Pilot Case Series Study. JMIR Form Res. 2024 Jan 17;8:e46367. doi: 10.2196/46367.

  PMID: 38231570 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jordana Sommer, MA

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Renée El-Gabalawy, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will employ a single-blind randomized design (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 two study groups).

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: September 10, 2020
• Study Start: December 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)