A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

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.

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Key information

Conditions

Hematuria Bladder Cancer Bladder Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Bladder Diseases Urinary Bladder Neoplasms Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Cystoscopy

Behavioral

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

Behavioral

Routine cystoscopy as done as part of routine clinical practice

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Aug 22, 2017
Registry last updated: Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed