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CompletedNCT03257293Updated Apr 27, 2021

A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

An interventional study of Modified Cystoscopy and Routine Cystoscopy in Hematuria, Bladder Cancer and Bladder Disease, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by Western University, Canada · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hematuria
  • Bladder Cancer
  • Bladder Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
93 participants (actual)

Study arms

  • Active comparator
    Routine Cystoscopy

    Behavioral: Routine Cystoscopy

  • Experimental
    Modified Cystoscopy

    Behavioral: Modified Cystoscopy

Interventions

  • BehavioralModified 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.

  • BehavioralRoutine Cystoscopy

    Routine cystoscopy as done as part of routine clinical practice

05

What researchers measure

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.

    Time frame: 1 hour

06

Study locations

1 site
  • London Health Sciences Centre
    London, Ontario, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03257293
Lead sponsor
Western University, Canada
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Apr 1, 2018
Primary completion
Aug 1, 2020
Completion
Aug 1, 2020
Last update
Apr 27, 2021

Study contacts

Nicholas Power, MD
principal investigator · London Health Sciences Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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