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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern University, Canada

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

378 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators