Enhancing Patient Comfort and Reducing Anxiety During Flexible Cystoscopy and Bladder Instillation in Bladder Cancer Patients: A Randomized Controlled Trial and Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Optimized Timing of Intravesical Lidocaine Gel, Calming Music During Procedure, Visual Distraction with Screen Content, Calming Ambient Lighting.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
Bladder cancer is one of the most common malignancies of the urinary tract, and many patients require frequent endoscopic procedures as part of diagnosis, treatment, and surveillance. Flexible cystoscopy and intravesical instillation are standard procedures but are often associated with patient discomfort, anxiety, and negative procedural experiences. Improving comfort during these procedures has the potential to increase patient satisfaction, reduce procedural avoidance, and improve adherence to follow-up care.
Rationale Although flexible cystoscopy is minimally invasive, it can cause pain, embarrassment, and significant anxiety. Standard strategies to improve patient comfort, such as intravesical anesthetic gel, are variably effective. Previous work suggests that environmental modifications (e.g., calming music, ambient lighting), behavioral strategies (e.g., distraction), and optimization of local anesthetic use may enhance the patient experience. However, rigorous randomized controlled data in the cystoscopy and bladder instillation setting are lacking.
This study will address this gap by systematically evaluating comfort-enhancing interventions during flexible cystoscopy and bladder instillation for bladder cancer patients.
Study Objectives The primary objective is to determine whether comfort interventions reduce patient-reported anxiety and pain during flexible cystoscopy and bladder instillation procedures.
Secondary objectives include:
* To assess whether these interventions improve overall patient satisfaction. * To determine whether these interventions influence willingness to undergo repeat procedures. * To explore procedural efficiency, clinician satisfaction, and feasibility of implementing these interventions in routine care.
Study Design This study includes both a randomized controlled trial (RCT) and an observational component.
Randomized Controlled Trial (Interventional Arm):
Participants will be randomly assigned to receive standard care or a comfort interventions, such as:
* Optimized timing of intravesical anesthetic gel * Calming background music * Visual distraction or environmental modifications * Ambient lighting changes
Outcomes will be assessed using validated questionnaires (e.g., visual analogue scales for pain and anxiety, standardized patient-reported outcome measures).
Observational Arm:
Parallel to the RCT, observational data will be collected from a cohort undergoing flexible cystoscopy or intravesical instillation under standard care conditions. This will allow comparison with historical and real-world data, provide additional context for generalizability, and help inform the feasibility of widespread adoption of interventions.
Participant Population Participants will include adults undergoing flexible cystoscopy or bladder instillation for bladder cancer. Eligibility is broad to maximize generalizability, with minimal exclusion criteria. Translation services and literacy supports will be offered to ensure equitable participation.
Study Procedures
* All participants will undergo flexible cystoscopy or intravesical instillation as clinically indicated. * RCT participants will be randomized to intervention vs. standard care groups. * Participants will complete short questionnaires before, during, and after the procedure assessing comfort, pain, and anxiety. * Follow-up will include willingness to undergo repeat procedures and satisfaction ratings.
Outcomes
* Primary outcomes: Patient-reported pain and anxiety scores. * Secondary outcomes: Overall satisfaction, willingness to repeat procedure, efficiency measures, and clinician feedback.
Significance This study will generate high-quality evidence on practical, low-cost, and easily implementable interventions to improve the patient experience during routine urological procedures. Findings may inform best practice guidelines, enhance patient-centered care, and support broader adoption of comfort-enhancing strategies in cystoscopy services.
Interventions
- Other 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. - Behavioral 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. - Behavioral 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. - Other 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. - Behavioral 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.
Primary outcome measures
- Patient-reported Anxiety (VAS 0-100) [Time frame: Before and immediately after the procedure (within 30 minutes).]
- Patient-reported Anxiety (VAS 0-100) [Time frame: Immediately after the procedure (within 30 minutes).]
Secondary outcome measures (4)
- Change in Anxiety from Baseline (VAS 0-100) [Time frame: Before and immediately after procedure (within 30 minutes).]
- Baseline Anxiety (GAD-7 Score) [Time frame: At baseline (pre-procedure, prior to randomization).]
- Patient Satisfaction (Survey-based) [Time frame: Immediately post-procedure and within 24 hours.]
- Quality of Life (EORTC QLQ-C30 Global Health Status) [Time frame: Prior to procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- Victoria Hospital - London Health Sciences Center — London
Identifiers
NCT: NCT07204301 · 16395