FeasibilityNCT06534086
Virtual Reality for Urological Procedures
A study testing Virtual reality (VR) guided meditation therapy and Treatment as usual in people with Feasibility and Anxiety State, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Feasibility, Anxiety State, Pain
- What is being tested?
- Virtual reality (VR) guided meditation therapy and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jun 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Virtual Reality Intervention for Patients Undergoing Urological Procedures
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.
- Conditions
- Feasibility, Anxiety State, Pain, Satisfaction, Patient
- Being tested
- Virtual reality (VR) guided meditation therapy, Treatment as usual
- Keywords
- feasibility, virtual reality, perioperative mental health
- Medical subject headings
- Anxiety Disorders, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality (VR) guided meditation therapyDevice
Tripp application on Meta Quest 3 VR headset
Treatment as usualOther
No VR, local anesthetic only
| Study group | Role | What they receive |
|---|---|---|
| Cystoscopy VR intervention | Experimental | Local anesthetic and VR intervention Receives: Device: Virtual reality (VR) guided meditation therapy |
| Cystoscopy treatment as usual | Active comparator | Local anesthetic only Receives: Other: Treatment as usual |
| Vasectomy VR intervention | Experimental | Local anesthetic and VR intervention Receives: Device: Virtual reality (VR) guided meditation therapy |
| Vasectomy treatment as usual | Active comparator | Local anesthetic only Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of individuals who consent to participation and the number of recruited participants per week
Measured: through study completion, up to 1 year
Inclusion criteria and demographic and surgery-related differences
Proportion of individuals who meet inclusion criteria and any demographic and surgery-related differences in potentially eligible participants
Measured: through study completion, up to 1 year
Retention of participants in the study
Proportion of individuals who tolerate the intervention and complete the study
Measured: Immediate post-operative
Acceptability through elevate scores on the Virtual Reality Impression Scale
Acceptability of the VR program during urological procedures (0 thru 100, 100=positive impressions)
Measured: Immediate post-operative
Impressions of the VR based on open-ended responses on the Virtual Reality Impression Scale
Negative and positive impressions of the VR intervention (open ended/qualitative)
Measured: Immediate post-operative
Secondary outcomes (9)
Scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (and adapted Anxiety Thermometer)
Brief self-report visual analogue scales (VAS) for anxiety/distress (0 thru 10, 10=worse anxiety/distress)
Measured: Pre-operative, acute post-operative (immediately following surgery)
Visual Analogue Scale pain severity
Brief self-report visual analogue scales (VAS) for acute pain (o thru 10, 10=more severe pain)
Measured: Peri-operative (mid-way through procedure)
Visual Analogue Scale anxiety severity
Brief self-report visual analogue scales (VAS) for acute anxiety (0 thru 10, 10=more severe anxiety)
Measured: Peri-operative (mid-way through procedure)
State Trait Anxiety Inventory (STAI) elevated scores
Brief self-report questionnaire with questions surrounding anxiety traits (0 thru 63, higher score=more severe anxiety)
Measured: Pre-operative, acute post-operative (immediately following surgery)
PROMIS Pain Intensity Scale total score
Brief self-report questionnaire with questions surrounding experienced pain (3 thru 15, 15=greater pain severity)
Measured: Acute post-operative (immediately following surgery)
i-Group Presence Questionnaire (IPQ) score
Brief self-report questionnaire with questions surrounding VR experience (spatial presence, involvement, experience realism), higher scores=greater presence
Measured: Acute post-operative (immediately following surgery)
Satisfaction With Surgery score
Item to assess overall satisfaction with surgery (0 thru 10, 10=greater satisfaction)
Measured: Acute post-operative (immediately following surgery)
Selection of VR experience
What Tripp experience that participants select (out of 5 potential programs)
Measured: Pre-operative
Subjective assessment of time spent in VR vs. actual time in VR
Perception of time during procedure compared to actual time among those in VR
Measured: Evaluated immediate post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start6 Jun 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeasibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Other = feasibility (primary) + clinical pilot outcomes (secondary)
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renée El-Gabalawy, University of Manitoba
- Investigators
- Renée El-Gabalawy, PhD, Principal investigator, University of ManitobaPremal Patel, MD, Principal investigator, University of ManitobaSimone Gentile, BSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534086
- Sponsor's protocol ID
- HS26202
- Status last verified
- Aug 2024
- First submitted
- 12 Jul 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Virtual Reality Intervention for Patients Undergoing Urological Procedures
- ClinicalTrials.gov ID
- NCT06534086
- Acronym / sponsor ID
- HS26202
- Conditions
- Feasibility, Anxiety State, Pain, Satisfaction, Patient
- Keywords
- feasibility, virtual reality, perioperative mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Other = feasibility (primary) + clinical pilot outcomes (secondary)
| Arm | Type | Receives |
|---|---|---|
| Cystoscopy VR intervention | Experimental | Device: Virtual reality (VR) guided meditation therapyLocal anesthetic and VR intervention |
| Cystoscopy treatment as usual | Active comparator | Other: Treatment as usualLocal anesthetic only |
| Vasectomy VR intervention | Experimental | Device: Virtual reality (VR) guided meditation therapyLocal anesthetic and VR intervention |
| Vasectomy treatment as usual | Active comparator | Other: Treatment as usualLocal anesthetic only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality (VR) guided meditation therapyTripp application on Meta Quest 3 VR headset | Device | Cystoscopy VR intervention, Vasectomy VR intervention |
| Treatment as usualNo VR, local anesthetic only | Other | Cystoscopy treatment as usual, Vasectomy treatment as usual |
Primary outcome
Recruitment rate
Time frame: through study completion, up to 1 year
Proportion of individuals who consent to participation and the number of recruited participants per week
Inclusion criteria and demographic and surgery-related differences
Time frame: through study completion, up to 1 year
Proportion of individuals who meet inclusion criteria and any demographic and surgery-related differences in potentially eligible participants
Retention of participants in the study
Time frame: Immediate post-operative
Proportion of individuals who tolerate the intervention and complete the study
Acceptability through elevate scores on the Virtual Reality Impression Scale
Time frame: Immediate post-operative
Acceptability of the VR program during urological procedures (0 thru 100, 100=positive impressions)
Impressions of the VR based on open-ended responses on the Virtual Reality Impression Scale
Time frame: Immediate post-operative
Negative and positive impressions of the VR intervention (open ended/qualitative)
9 secondary outcomes
Scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (and adapted Anxiety Thermometer)
Time frame: Pre-operative, acute post-operative (immediately following surgery)
Visual Analogue Scale pain severity
Time frame: Peri-operative (mid-way through procedure)
Visual Analogue Scale anxiety severity
Time frame: Peri-operative (mid-way through procedure)
State Trait Anxiety Inventory (STAI) elevated scores
Time frame: Pre-operative, acute post-operative (immediately following surgery)
PROMIS Pain Intensity Scale total score
Time frame: Acute post-operative (immediately following surgery)
i-Group Presence Questionnaire (IPQ) score
Time frame: Acute post-operative (immediately following surgery)
Satisfaction With Surgery score
Time frame: Acute post-operative (immediately following surgery)
Selection of VR experience
Time frame: Pre-operative
Subjective assessment of time spent in VR vs. actual time in VR
Time frame: Evaluated immediate post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renée El-Gabalawy, PhD principal investigator
University of Manitoba
Premal Patel, MD principal investigator
University of Manitoba
Simone Gentile, BSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality (VR) guided meditation therapy and Treatment as usual in people with Feasibility and Anxiety State, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: through study completion, up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.