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临床试验/NCT06944314
NCT06944314Enrolling By Invitation不适用

Physicians' Perception About Patient Pain in Flexible Cystoscopy With Local Anesthesia

Marmara University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
120
试验地点
1
主要终点
Physicians' Perception about Patient Pain in Flexible Cystoscopy with Local Anesthesia

研究概览

简要总结

Cystoscopy with local anesthesia is commonly performed for the follow-up of bladder cancer, evaluation of hematuria, assessment of urethral strictures, and examination of the lower urinary tract. While some patients tolerate the procedure comfortably, others may exhibit heightened sensitivity and difficulty tolerating it. In certain cases, even when the procedure is completed, the level of pain experienced and the resistance demonstrated by the patient may render cystoscopy a challenging experience for both the patient and the physician. The physician's perception of the patient's pain may differ from the pain reported by the patient. Currently, there is no available data in the literature regarding the relationship between pre-procedural anxiety and depression levels and the pain experienced during cystoscopy, nor regarding the physician's perception of that pain. The primary objective of the study is to compare the patient-reported pain score with the physician's perception of the pain experienced by the patient. A secondary objective is to evaluate the pre-procedure anxiety and depression scores, along with intra-procedural pain scores, in patients undergoing flexible cystoscopy under local anesthesia.

详细描述

Cystoscopy is one of the most frequently performed procedures in the field of urology. Its widespread application, the impracticality of administering general anesthesia to all patients, and advancements in medical technology have led to the development of devices that enable cystoscopy to be performed with local or intraurethral anesthesia. As a result, cystoscopy under local anesthesia is commonly utilized for the follow-up of bladder cancer, evaluation of hematuria, assessment of urethral strictures, and examination of the lower urinary tract. Both rigid and flexible cystoscopes can be used for this purpose, with flexible instruments generally offering greater comfort for procedures involving local anesthesia.

In patients undergoing cystoscopy with local anesthesia, the standard approach includes the intraurethral administration of a local anesthetic or lubricant prior to the procedure to enhance patient comfort. While some patients tolerate the procedure well, others may exhibit heightened sensitivity and limited tolerance. Even in cases where the procedure is completed, the pain experienced and the resistance demonstrated by the patient may pose challenges for both the patient and the physician. Occasionally, a mismatch is observed between the patient's reported pain and the resistance displayed. The physician's perception of the patient's pain may also differ from the pain reported by the patient.

Previous studies have explored factors that can influence and reduce the perception of pain during cystoscopy performed under local anesthesia. However, data are lacking regarding the relationship between patients' pre-procedural anxiety and depression levels and the pain experienced during the procedure, as well as the physician's perception of that pain. The primary aim of the study is to compare the pain score reported by the patient with the pain level perceived by the physician. A secondary objective is to evaluate patients' pre-procedure anxiety and depression scores, along with their pain scores during the procedure, in the context of flexible cystoscopy performed under local anesthesia.

The study will include male patients aged 18 years and older who are undergoing cystoscopy due to urological complaints. Exclusion criteria include patients with known urethral strictures or those diagnosed with strictures during cystoscopy, individuals with allergies to the local anesthetic used, and patients with cardiopulmonary conditions that preclude the procedure.

Participants will be asked to complete the Hospital Anxiety and Depression Scale (HADS) for the assessment of general anxiety and depression, as well as the Visual Analog Scale (VAS) for pain and anxiety, at the time of admission. All patients will receive standard intraurethral local anesthesia 15 minutes prior to the procedure. Following cystoscopy, participants will complete the VAS for anxiety and pain again, 15 minutes after the procedure, to evaluate their intra-procedural experience. In addition, the physician performing the procedure will complete the VAS for anxiety and pain based on their perception of the patient's experience.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The people who randomize the patient, prepare the patient for cystoscopy, perform the cystoscopy and evaluate the results are different and will be blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Minimum Age: 18 Years Maximum Age: Not Applicable Sex: Male Gender Based: Yes Male patients over 18 years of age who need cystoscopy due to urologic complaints will be included in the study.
  • •Accepts Healthy Volunteers: No
  • •Inclusion Criteria:
  • •Male patients
  • •Over 18 years of age
  • •Patients for whom diagnostic cystoscopy is indicated for a urologic reason

排除标准

  • •Female patients
  • •Patients younger than 18 years of age
  • •Patients with known urethral stricture
  • •Patients with urethral stricture detected during cystoscopy
  • •Patients who cannot tolerate flexible cystoscopy with local anesthesia

研究组 & 干预措施

Assistant Urology Doctor (2 years)

Experimental

Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by an Assistant Urology Doctor with 2 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.

干预措施: Flexible Cystoscopy (Procedure)

Assistant Urology Doctor (2 years)

Experimental

Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by an Assistant Urology Doctor with 2 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.

干预措施: Diagnostic procedures (Procedure)

Assistant Urology Doctor (4 years)

Experimental

Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by an Assistant Urology Doctor with 4 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.

干预措施: Diagnostic procedures (Procedure)

Assistant Urology Doctor (4 years)

Experimental

Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by an Assistant Urology Doctor with 4 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.

干预措施: Flexible Cystoscopy (Procedure)

Specialist Urology Physician (<5 years experience)

Experimental

Experimental: Specialist Urology Physician (<5 years experience) Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by a Specialist Urology Physician with less than 5 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.

干预措施: Diagnostic procedures (Procedure)

Specialist Urology Physician (<5 years experience)

Experimental

Experimental: Specialist Urology Physician (<5 years experience) Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by a Specialist Urology Physician with less than 5 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.

干预措施: Flexible Cystoscopy (Procedure)

Specialist Urology Physician (>5 years experience)

Experimental

Experimental: Specialist Urology Physician (>5 years experience) Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by a Specialist Urology Physician with more than 5 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.

干预措施: Diagnostic procedures (Procedure)

Specialist Urology Physician (>5 years experience)

Experimental

Experimental: Specialist Urology Physician (>5 years experience) Intervention: Diagnostic Flexible Cystoscopy Other Names: Flexible Cystoscopy, Cystoscopy Arm Description: The procedure will be performed by a Specialist Urology Physician with more than 5 years of experience. The goal is to evaluate the patient's pain perception during diagnostic flexible cystoscopy.

干预措施: Flexible Cystoscopy (Procedure)

结局指标

主要结局

Physicians' Perception about Patient Pain in Flexible Cystoscopy with Local Anesthesia

时间窗: Immediately after the procedure, upon completion of the diagnostic flexible cystoscopy (15 minutes post-procedure).

The study will examine the differences in the perception of pain scores in patients according to the years of experience of physicians. Scale Used: Visual Analog Scale (VAS) for Pain Minimum Value: 0 (No pain) Maximum Value: 10 (Worst possible pain) Interpretation: Higher scores indicate worse pain perception.

次要结局

  • Association between patients' pre-procedure HAD score and pain(Pre-procedure (baseline), immediately after the procedure (15 minutes post-procedure).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tarik Emre Sener

Associate Professor

Marmara University

研究点 (1)

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