A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

NCT03257293 | Completed

• 1 other identifier: 10016740
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematuria; Bladder Cancer; Bladder Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Routine Cystoscopy

ACTIVE COMPARATOR

Behavioral: Routine Cystoscopy

Modified Cystoscopy

EXPERIMENTAL

Behavioral: Modified Cystoscopy

Interventions

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.

Modified Cystoscopy

Routine Cystoscopy BEHAVIORAL

Routine cystoscopy as done as part of routine clinical practice

Routine Cystoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18 undergoing cystoscopy for the first time for diagnostic investigation will be approached to participate in this study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

MeSH Terms

Conditions

Hematuria; Urinary Bladder Neoplasms; Urinary Bladder Diseases

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Nicholas Power, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 22, 2017
• Study Start: April 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)