A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

• Sponsor: Western University, Canada (Other)
• Overall Status: Completed
• CT.gov ID: NCT03257293
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arms: 2
• Actual Duration (Months): 28
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematuria; Bladder Cancer; Bladder Disease	Behavioral: Modified Cystoscopy; Behavioral: Routine Cystoscopy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Control Trial of a Modified Cystoscopy Method to Reduce Pain Perception
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: Aug 1, 2020
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Routine Cystoscopy	Behavioral: Routine Cystoscopy; Routine cystoscopy as done as part of routine clinical practice
Experimental: Modified Cystoscopy	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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Health Sciences Centre	London	Ontario	Canada

Sponsors and Collaborators

• Western University, Canada

Investigators

• Principal Investigator: Nicholas Power, MD, London Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Western University, Canada
• ClinicalTrials.gov Identifier: NCT03257293
• Other Study ID Numbers: 10016740
• First Posted: Aug 22, 2017
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hematuria; Urinary Bladder Diseases

Study Results

No Results Posted as of Apr 27, 2021