A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

Bladder Cancer Clinical Trial

Official title:

A Randomized Control Trial of a Modified Cystoscopy Method to Reduce Pain Perception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257293
• Other study ID #: 10016740
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: April 2021
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Disease
• Hematuria
• Urinary Bladder Diseases

Intervention

Behavioral:
• Modified Cystoscopy
The objective of this study is to examine whether a non-pharmacologic modification in procedure of cystoscopies improves patient perception of pain and discomfort.
• Routine Cystoscopy
Routine cystoscopy as done as part of routine clinical practice

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Experience rated on the visual analogue scale	The primary outcome of the study will be pain experience, as rated on the visual analogue scale provided.	1 hour