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A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

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ClinicalTrials.gov Identifier: NCT03257293
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hematuria Bladder Cancer Bladder Disease Behavioral: Modified Cystoscopy Behavioral: Routine Cystoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 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 : April 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

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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.




Primary Outcome Measures :
  1. Pain Experience rated on the visual analogue scale [ Time Frame: 1 hour ]
    The primary outcome of the study will be pain experience, as rated on the visual analogue scale provided.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257293


Contacts
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Contact: Nicholas Power, MD 519-667-6787 nicholas.power@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Nicholas Power, MD London Health Sciences Centre

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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03257293     History of Changes
Other Study ID Numbers: 10016740
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Hematuria
Urinary Bladder Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urologic Diseases
Urination Disorders
Hemorrhage
Pathologic Processes