Enhancing Patient Comfort and Reducing Anxiety During Flexible Cystoscopy and Bladder Instillation in Bladder Cancer Patients: A Randomized Controlled Trial and Observational Study
NCT07204301 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 378
Last updated 2025-10-02
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
Conditions
Interventions
- OTHER
-
Optimized Timing of Intravesical Lidocaine Gel
Procedural modification of intravesical anesthetic gel administration. Lidocaine gel is instilled before and after flexible cystoscopy or bladder instillation to optimize mucosal anesthesia. This differs from standard practice where timing is not standardized - usually just before flexible cystoscopy.
- BEHAVIORAL
-
Calming Music During Procedure
Participants listen to a standardized playlist of calming instrumental music delivered through headphones during the procedure. Intervention is intended to reduce procedural anxiety and discomfort.
- BEHAVIORAL
-
Visual Distraction with Screen Content
Participants watch standardized visual content (e.g., relaxing video) on a screen or tablet during cystoscopy or bladder instillation. Designed to distract attention and enhance comfort.
- OTHER
-
Calming Ambient Lighting
Flexible cystoscopy or intravesical instillation performed under standardized calming ambient lighting (blue-hue) instead of standard clinical lighting. Intervention aims to promote relaxation and reduce anxiety.
- BEHAVIORAL
-
Peak-End Modification of Procedure
Modification of the procedural ending based on the psychological "peak-end rule." The end of the cystoscopy or instillation is deliberately altered to reduce final discomfort, aiming to improve overall remembered patient experience.
Sponsors & Collaborators
-
Western University, Canada
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-01
- Primary Completion
- 2026-07-01
- Completion
- 2026-07-01
Countries
- Canada
Study Locations
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