Clinical trial · Interventional
Enhancing Patient Comfort and Reducing Anxiety During Flexible Cystoscopy and Bladder Instillation in Bladder Cancer Patients: A Randomized Controlled Trial and Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calming Ambient Lighting | Other | — | UNRESOLVED |
| Calming Music During Procedure | Behavioral | — | UNRESOLVED |
| Optimized Timing of Intravesical Lidocaine Gel | Other | — | UNRESOLVED |
| Peak-End Modification of Procedure | Behavioral | — | UNRESOLVED |
| Visual Distraction with Screen Content | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- NO_INTERVENTION
- label
- No Intervention
- description
- Usual flexible cystoscopy or intravesical instillation under routine clinic conditions. Local anesthetic gel used per usual practice; no added comfort intervention.
- type
- EXPERIMENTAL
- label
- Optimized Anesthetic Gel Timing
- description
- 2% lidocaine uro-gel instilled before and after procedure to maximize mucosal anesthesia.
- interventionNames
- Other: Optimized Timing of Intravesical Lidocaine Gel
- type
- EXPERIMENTAL
- label
- Calming Music
- description
- Patients listen to a standardized calming playlist via headphones during the procedure.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: Individuals \<18 years of age. * 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. * Individuals for whom, in the opinion of the treating urologist, participation would pose undue clinical risk or interfere with urgent clinical care.
References
Publications (0)
Data not yet available