Clinical trial NCT06534086: Virtual Reality for Urological Procedures
Official title: Feasibility of a Virtual Reality Intervention for Patients Undergoing Urological Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility
Anxiety State
Pain
Satisfaction, Patient
Keywords: feasibility
virtual reality
perioperative mental health
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Other = feasibility (primary) + clinical pilot outcomes (secondary)
Primary purpose: OTHER

Brief summary: It is standard practice for most cystoscopies and vasectomies in an office or outpatient setting to be performed under local anesthesia while the patient is awake and conscious. However, given the conscious nature of these procedures, patients may experience anxiety-inducing stressors that they otherwise would not under general anesthesia. Stressors such as hearing surgical terminology, technical discussion, and injection of local anesthetic have been previously documented as sources of perioperative anxiety and pain in awake surgeries.

The current study will examine the feasibility and pilot outcomes of Virtual Reality (VR) guided meditation therapy during cystoscopies and vasectomies. Feasibility will be examined through: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures (including randomization) and outcome measures, and (3) participant acceptability and suitability of the VR intervention during the procedures. The investigators will also evaluate pilot outcomes of the VR intervention on pain, anxiety, and overall satisfaction with the procedure. Results of this study will inform the development of a large-scale randomized clinical trial (RCT) to evaluate the efficacy of this intervention.

Participants will be asked to complete questionnaires before and after their procedure and will be asked for a verbal measure of their pain and anxiety during the procedure.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* can speak and read English
* have an indication for a cystoscopy or elected for a vasectomy
* are scheduled to undergo their respective procedure under local anesthesia at the Men's Health Clinic between the dates of May-November 2024.

Exclusion Criteria:

* those who are not competent to provide informed consent (e.g., due to cognitive impairment)
* those who are unable to participate in a VR intervention (e.g., due to visual or auditory impairment)

Primary outcomes:
measure: Recruitment rate
timeFrame: through study completion, up to 1 year
measure: Inclusion criteria and demographic and surgery-related differences
timeFrame: through study completion, up to 1 year
measure: Retention of participants in the study
timeFrame: Immediate post-operative
measure: Acceptability through elevate scores on the Virtual Reality Impression Scale
timeFrame: Immediate post-operative
measure: Impressions of the VR based on open-ended responses on the Virtual Reality Impression Scale
timeFrame: Immediate post-operative
Secondary outcomes:
measure: Scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (and adapted Anxiety Thermometer)
timeFrame: Pre-operative, acute post-operative (immediately following surgery)
measure: Visual Analogue Scale pain severity
timeFrame: Peri-operative (mid-way through procedure)
measure: Visual Analogue Scale anxiety severity
timeFrame: Peri-operative (mid-way through procedure)
measure: State Trait Anxiety Inventory (STAI) elevated scores
timeFrame: Pre-operative, acute post-operative (immediately following surgery)
measure: PROMIS Pain Intensity Scale total score
timeFrame: Acute post-operative (immediately following surgery)
measure: i-Group Presence Questionnaire (IPQ) score
timeFrame: Acute post-operative (immediately following surgery)
measure: Satisfaction With Surgery score
timeFrame: Acute post-operative (immediately following surgery)
measure: Selection of VR experience
timeFrame: Pre-operative
measure: Subjective assessment of time spent in VR vs. actual time in VR
timeFrame: Evaluated immediate post-operative
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Men's Health Clinic
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Renée El-Gabalawy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Premal Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Simone Gentile, BSc
role: PRINCIPAL_INVESTIGATOR
References: