A Trial of a Modified Cystoscopy Method to Reduce Pain Perception
Primary Purpose
Hematuria, Bladder Cancer, Bladder Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Modified Cystoscopy
Routine Cystoscopy
Sponsored by
About this trial
This is an interventional supportive care trial for Hematuria
Eligibility Criteria
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.
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Routine Cystoscopy
Modified Cystoscopy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03257293
First Posted
August 18, 2017
Last Updated
April 26, 2021
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT03257293
Brief Title
A Trial of a Modified Cystoscopy Method to Reduce Pain Perception
Official Title
A Randomized Control Trial of a Modified Cystoscopy Method to Reduce Pain Perception
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematuria, Bladder Cancer, Bladder Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine Cystoscopy
Arm Type
Active Comparator
Arm Title
Modified Cystoscopy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Modified Cystoscopy
Intervention Description
The objective of this study is to examine whether a non-pharmacologic modification in procedure of cystoscopies improves patient perception of pain and discomfort.
Intervention Type
Behavioral
Intervention Name(s)
Routine Cystoscopy
Intervention Description
Routine cystoscopy as done as part of routine clinical practice
Primary Outcome Measure Information:
Title
Pain Experience rated on the visual analogue scale
Description
The primary outcome of the study will be pain experience, as rated on the visual analogue scale provided.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Power, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial of a Modified Cystoscopy Method to Reduce Pain Perception
We'll reach out to this number within 24 hrs