A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

Not Applicable

Completed

• Conditions: Hematuria; Bladder Cancer; Bladder Disease
• Interventions: Behavioral: Routine Cystoscopy; Behavioral: Modified Cystoscopy

• Registration Number: NCT03257293
• Lead Sponsor: Western University, Canada

Brief Summary

The goal of this project is to improve patient experience of cystoscopy using a non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for urology patients and is usually performed without sedation. However, there is limited research into reduction of patient discomfort throughout this procedure. The proposed modification technique was selected based on a well-documented psychological phenomenon in which only particular moments over the course of an aversive event determine the resultant perception of the experience. It is hypothesized that implementation of the technique will decrease the recalled pain intensity of the cystoscopy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-22
• Study Start: 2018-04-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Patients over the age of 18 undergoing cystoscopy for the first time for diagnostic investigation will be approached to participate in this study.

Exclusion Criteria

• Cystoscopies involving other interventions concurrently (e.g. biopsy, urethral dilation, removal of ureteral stent, etc.) will be excluded.
• Patients currently taking medication for chronic pain (e.g. opioids, Tricyclic antidepressants (TCAs)) will be excluded from the study.
• Patients less than 18 years of age will be excluded.
• Patients who have received a cystoscopy previously will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Cystoscopy	Routine Cystoscopy	-
Modified Cystoscopy	Modified Cystoscopy	-

Primary Outcome Measures

Name	Time	Method
Pain Experience rated on the visual analogue scale	1 hour	The primary outcome of the study will be pain experience, as rated on the visual analogue scale provided.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada