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Completed

NCT Number: NCT04544618

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

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

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Key information

Conditions

Anxiety State Anxiety Disorders Mental Disorders Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences Centre

Winnipeg, Manitoba, R3E 3N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Self-reported impressions of the virtual reality operating room simulation

    Time frame: Baseline

    Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention

  2. Self-reported impressions of the virtual reality operating room simulation

    Time frame: 5 days

    Patient acceptability questionnaire with open and close-ended items assessing patients' impressions of the intervention

Secondary outcomes

  1. NCCN Distress Thermometer

    Time frame: 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

  2. NCCN Anxiety Thermometer

    Time frame: 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

  3. iGroup Presence Questionnaire

    Time frame: Immediately after the intervention

    Assessing the sense of presence experienced by participants in the virtual environment

  4. Preoperative Intrusive Thoughts Inventory (PITI)

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

    PITI questionnaire

  5. Amsterdam Preoperative Anxiety Information Scale (APAIS)

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

    APAIS questionnaire

Other outcomes

  1. PROMIS emotional distress- anxiety

    Time frame: Baseline, 5 days, and 30 days

    PROMIS anxiety questionnaire

  2. PROMIS emotional distress- depression

    Time frame: Baseline, 5 days, and 30 days

    PROMIS depression questionnaire

  3. PROMIS global health

    Time frame: Baseline, 5 days, and 30 days

    PROMIS global health questionnaire

  4. PROMIS fatigue

    Time frame: Baseline, 5 days, and 30 days

    PROMIS fatigue questionnaire

  5. PROMIS emotional support

    Time frame: Baseline, 5 days, and 30 days

    PROMIS emotional support questionnaire

  6. PROMIS pain intensity

    Time frame: 5 days and 30 days

    PROMIS pain intensity questionnaire

  7. Peritraumatic Distress Inventory (PDI)

    Time frame: Baseline and 5 days

    PDI questionnaire

  8. Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)

    Time frame: Baseline and 30 days

    PC-PTSD-5 questionnaire

  9. Brief Resilient Coping Scale (BRCS)

    Time frame: Baseline, 5 days, and 30 days

    BRCS questionnaire

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Preoperative Virtual Reality for Cancer Surgery Patients: A Feasibility and Pilot Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2020
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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