A Trial of a Modified Cystoscopy Method to Reduce Pain Perception

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-08-01

Brief Summary

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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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Detailed Description

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Conditions

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Hematuria Bladder Cancer Bladder Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Routine Cystoscopy

Group Type ACTIVE_COMPARATOR

Routine Cystoscopy

Intervention Type BEHAVIORAL

Routine cystoscopy as done as part of routine clinical practice

Modified Cystoscopy

Group Type EXPERIMENTAL

Modified Cystoscopy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Routine Cystoscopy

Routine cystoscopy as done as part of routine clinical practice

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No