Enhancing Patient Comfort and Reducing Anxiety During Flexible Cystoscopy and Bladder Instillatio… (NCT07204301) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Enhancing Patient Comfort and Reducing Anxiety During Flexible Cystoscopy and Bladder Instillation in Bladder Cancer Patients: A Randomized Controlled Trial and Observational Study
Canada378 participantsStarted 2025-11-01
Plain-language summary
The goal of this clinical trial is to learn if certain comfort-enhancing interventions can reduce pain and anxiety during flexible cystoscopy and bladder instillation in patients with bladder cancer. The main questions it aims to answer are:
* Do these interventions reduce patient-reported anxiety during the procedure?
* Do these interventions reduce patient-reported pain or discomfort during the procedure?
Researchers will compare patients receiving comfort interventions (such as timing of anesthetic gel, calming music, or visual distraction) to those receiving standard care to see if these changes improve patient experience.
Participants will:
* Undergo a flexible cystoscopy or bladder instillation as part of their usual care
* Be randomly assigned to receive one or more comfort interventions, or standard care
* Complete short questionnaires about their pain, comfort, and anxiety
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Diagnosis of bladder cancer undergoing diagnostic/surveillance flexible cystoscopy or intravesical bladder instillation in the outpatient urology clinic
* Able to provide informed consent
Exclusion Criteria:
Individuals \<18 years of age.
* Individuals unable to provide informed consent (e.g., diminished or fluctuating capacity).
* Individuals unable to communicate verbally with study staff (e.g., severe speech/hearing impairment without assistive support available).
* Individuals with severe cognitive impairment or acute distress at the time of approach that prevents informed consent.
* Individuals with known hypersensitivity or allergy to lidocaine, topical anesthetic gel, or any components used in the procedure.
* Individuals for whom, in the opinion of the treating urologist, participation would pose undue clinical risk or interfere with urgent clinical care.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient-reported Anxiety (VAS 0-100)
Timeframe: Before and immediately after the procedure (within 30 minutes).
2
Patient-reported Anxiety (VAS 0-100)
Timeframe: Immediately after the procedure (within 30 minutes).