Enhancing Patient Comfort and Reducing Anxiety During Flexible Cystoscopy and Bladder Instillation in Bladder Cancer Patients: A Randomized Controlled Trial and Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 378
- 试验地点
- 2
- 主要终点
- Patient-reported Anxiety (VAS 0-100)
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Patient-reported Anxiety (VAS 0-100)
时间窗: 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).
次要结局
- Change in Anxiety from Baseline (VAS 0-100)(Before and immediately after procedure (within 30 minutes).)
- Patient Satisfaction (Survey-based)(Immediately post-procedure and within 24 hours.)
- Baseline Anxiety (GAD-7 Score)(At baseline (pre-procedure, prior to randomization).)
- Quality of Life (EORTC QLQ-C30 Global Health Status)(Prior to procedure)
研究者
Nicholas Power
Principle Investigator
Western University, Canada