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

Anxiety State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544618
• Other study ID #: HS23957 (H2020:247)
• Secondary ID: 322523 340300 20
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety State

Intervention

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.

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PROMIS emotional distress- anxiety	PROMIS anxiety questionnaire	Baseline, 5 days, and 30 days
Other	PROMIS emotional distress- depression	PROMIS depression questionnaire	Baseline, 5 days, and 30 days
Other	PROMIS global health	PROMIS global health questionnaire	Baseline, 5 days, and 30 days
Other	PROMIS fatigue	PROMIS fatigue questionnaire	Baseline, 5 days, and 30 days
Other	PROMIS emotional support	PROMIS emotional support questionnaire	Baseline, 5 days, and 30 days
Other	PROMIS pain intensity	PROMIS pain intensity questionnaire	5 days and 30 days
Other	Peritraumatic Distress Inventory (PDI)	PDI questionnaire	Baseline and 5 days
Other	Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)	PC-PTSD-5 questionnaire	Baseline and 30 days
Other	Brief Resilient Coping Scale (BRCS)	BRCS questionnaire	Baseline, 5 days, and 30 days
Primary	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
Primary	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	NCCN Distress Thermometer	VAS self-reported distress on a scale of 0-10	Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days
Secondary	NCCN Anxiety Thermometer	VAS self-reported anxiety on a scale of 0-10	Baseline, up to 2 weeks after baseline on day of scheduled surgery, 5 days, and 30 days
Secondary	iGroup Presence Questionnaire	Assessing the sense of presence experienced by participants in the virtual environment	Immediately after the intervention
Secondary	Preoperative Intrusive Thoughts Inventory (PITI)	PITI questionnaire	Baseline and up to 2 weeks after baseline on day of scheduled surgery
Secondary	Amsterdam Preoperative Anxiety Information Scale (APAIS)	APAIS questionnaire	Baseline and up to 2 weeks after baseline on day of scheduled surgery