Enhancing Patient Comfort and Reducing Anxiety During Flexible Cystoscopy and Bladder Instillation in Bladder Cancer Patients: A Randomized Controlled Trial and Observational Study

Sponsor
Western University, Canada
Study ID
NCT07204301
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Optimized Timing of Intravesical Lidocaine Gel — OTHER
    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.
  • Calming Music During Procedure — BEHAVIORAL
    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.
  • Visual Distraction with Screen Content — BEHAVIORAL
    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.
  • Calming Ambient Lighting — OTHER
    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.
  • Peak-End Modification of Procedure — BEHAVIORAL
    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.

Study Details

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

Key Dates

First listed
Oct 2, 2025
Start date
Nov 1, 2025
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
378 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: No Intervention
    Usual flexible cystoscopy or intravesical instillation under routine clinic conditions. Local anesthetic gel used per usual practice; no added comfort intervention.
  • Experimental: Optimized Anesthetic Gel Timing
    2% lidocaine uro-gel instilled before and after procedure to maximize mucosal anesthesia.
  • Experimental: Calming Music
    Patients listen to a standardized calming playlist via headphones during the procedure.
  • Experimental: Visual Distraction
    Patients view standardized visual content on a tablet/monitor positioned for comfort-focused distraction.
  • Experimental: Ambient Lighting
    Procedure performed under standardized calming ambient lighting (blue-hue) per protocol.
  • Experimental: Peak-End Modification
    At the end of the procedure the flexible cystoscope is deliberately left in the bladder for 2 minutes, without manipulation, to reduce intensity/discomfort, based on the psychological principle of the "peak-end rule," aiming to improve overall remembered experience of the procedure.

Primary Outcome Measure

Patient-reported Anxiety (VAS 0-100) [ Time Frame: Before and immediately after the procedure (within 30 minutes). ]

Central Contacts

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