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Clinical Trials/NCT04544618
NCT04544618
Completed
Not Applicable

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

University of Manitoba1 site in 1 country23 target enrollmentDecember 1, 2021
ConditionsAnxiety State

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety State
Sponsor
University of Manitoba
Enrollment
23
Locations
1
Primary Endpoint
Self-reported impressions of the virtual reality operating room simulation
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
January 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jordana Sommer

Principal Investigator

University of Manitoba

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

  • 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)
  • 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)
  • Amsterdam Preoperative Anxiety Information Scale (APAIS)(Baseline and up to 2 weeks after baseline on day of scheduled surgery)

Study Sites (1)

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