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

NCT07204301 | Not Yet Recruiting

• 1 other identifier: 16395
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bladder Cancer

Keywords

flexible cystoscopy; bladder instillation; Patient comfort; Anxiety reduction; Pain management; Urologic oncology; Bladder cancer surveillance; Patient-reported outcomes; Procedural anxiety; Minimally invasive urology

Outcome Measures

Primary Outcomes (2)

• Patient-reported Anxiety (VAS 0-100)

  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).

  Before and immediately after the procedure (within 30 minutes).

• Patient-reported Anxiety (VAS 0-100)

  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).

  Immediately after the procedure (within 30 minutes).

Secondary Outcomes (4)

• Change in Anxiety from Baseline (VAS 0-100)

  Before and immediately after procedure (within 30 minutes).

• Baseline Anxiety (GAD-7 Score)

  At baseline (pre-procedure, prior to randomization).

• Patient Satisfaction (Survey-based)

  Immediately post-procedure and within 24 hours.

• Quality of Life (EORTC QLQ-C30 Global Health Status)

  Prior to procedure

Study Arms (6)

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.

Optimized Anesthetic Gel Timing

EXPERIMENTAL

2% lidocaine uro-gel instilled before and after procedure to maximize mucosal anesthesia.

Other: Optimized Timing of Intravesical Lidocaine Gel

Calming Music

EXPERIMENTAL

Patients listen to a standardized calming playlist via headphones during the procedure.

Behavioral: Calming Music During Procedure

Visual Distraction

EXPERIMENTAL

Patients view standardized visual content on a tablet/monitor positioned for comfort-focused distraction.

Behavioral: Visual Distraction with Screen Content

Ambient Lighting

EXPERIMENTAL

Procedure performed under standardized calming ambient lighting (blue-hue) per protocol.

Other: Calming Ambient Lighting

Peak-End Modification

EXPERIMENTAL

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.

Behavioral: Peak-End Modification of Procedure

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.

Also known as: Anesthetic Gel Timing Modification, Lidocaine Gel Administration Interval

Optimized Anesthetic Gel Timing

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.

Also known as: Relaxing Music, Music Therapy

Calming Music

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.

Also known as: Video Distraction, Screen Viewing

Visual Distraction

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.

Also known as: Lighting Modification

Ambient Lighting

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.

Also known as: Peak-End Rule Adjustment

Peak-End Modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Victoria Hospital - London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Agnosia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Nicholas E Power, MD

CONTACT

519-667-6787; nicholas.power@lhsc.on.ca

Kaydee Connors

CONTACT

519-685-8500; kaydee.connors@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Participants will be randomly assigned in a parallel fashion to either standard care or comfort-enhancing interventions during flexible cystoscopy or intravesical instillation. Each participant will remain in their assigned group for the duration of the study, and outcomes will be compared between groups. The interventions include practical, non-pharmacologic strategies (e.g., optimized timing of anesthetic gel, calming music, visual distraction, or ambient lighting changes) that can be readily implemented in routine urologic practice. This design allows assessment of the effectiveness of each intervention compared with usual care in a real-world procedural setting.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting documents will be available beginning 12 months after publication of the primary results, for a period of 5 years.
• Access Criteria: De-identified individual participant data (IPD) underlying published results will be made available to qualified researchers upon reasonable request. Access will be limited to investigators with a methodologically sound proposal addressing a scientifically valid research question. Requests must be reviewed and approved by the study steering committee. A data use agreement will be required prior to release. Data and supporting documents (protocol, SAP) will be shared via secure electronic transfer.

Locations

CA (1)