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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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.

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.

Study 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

Eligibility

Primary outcome measure(s)

• Patient-reported Anxiety (VAS 0-100) — Before and immediately after the procedure (within 30 minutes).
  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) — Immediately after the procedure (within 30 minutes).
  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).

Trial sites (1)

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