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A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03257293
Enrollment
93
Registered
2017-08-22
Start date
2018-04-01
Completion date
2020-08-01
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Bladder Disease, Hematuria

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.

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

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Experience rated on the visual analogue scale1 hourThe primary outcome of the study will be pain experience, as rated on the visual analogue scale provided.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026