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
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
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.
Parallel
Optimized Timing of Intravesical Lidocaine Gel
Other interventionProcedural 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.
Calming Music During Procedure
BehavioralParticipants listen to a standardized playlist of calming instrumental music delivered through headphones during the procedure. Intervention is intended to reduce procedural anxiety and discomfort.
Visual Distraction with Screen Content
BehavioralParticipants 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.
Calming Ambient Lighting
Other interventionFlexible 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.
Peak-End Modification of Procedure
BehavioralModification 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.
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Treatment groupsSee each treatment group below.
Patient-reported Anxiety (VAS 0-100)
Anxiety level reported by participants immediately following flexible cystoscopy or bladder instillation, measured on a 0-100 visual analogue scale (0 = no anxiety, 100 = worst possible anxiety).
Patient-reported Anxiety (VAS 0-100)
Pain/discomfort reported by participants immediately following flexible cystoscopy or bladder instillation, measured on a 0-100 visual analogue scale (0 = no pain, 100 = worst possible pain).
Change in Anxiety from Baseline (VAS 0-100)
Difference in anxiety score from pre-procedure to post-procedure, measured using the 0-100 visual analogue scale.
Baseline Anxiety (GAD-7 Score)
Participant baseline anxiety assessed using the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. Each item is scored 0-3; total score ranges 0-21, with higher scores indicating greater baseline anxiety.
Patient Satisfaction (Survey-based)
Patient-reported satisfaction with procedure experience, measured using a structured post-procedure survey (includes overall satisfaction, willingness to repeat, perceived helpfulness of interventions, comparison to expectations, likelihood to recommend, and post-procedure symptoms).
Quality of Life (EORTC QLQ-C30 Global Health Status)
Patient-reported quality of life assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Includes global health status and functional scales (0-100).
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This trial is not recruiting at the moment. You can still explore other options:
