<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03257293</url>
  </required_header>
  <id_info>
    <org_study_id>10016740</org_study_id>
    <nct_id>NCT03257293</nct_id>
  </id_info>
  <brief_title>A Trial of a Modified Cystoscopy Method to Reduce Pain Perception</brief_title>
  <official_title>A Randomized Control Trial of a Modified Cystoscopy Method to Reduce Pain Perception</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to improve patient experience of cystoscopy using a&#xD;
      non-pharmacologic modification of procedure. Cystoscopy is a common outpatient procedure for&#xD;
      urology patients and is usually performed without sedation. However, there is limited&#xD;
      research into reduction of patient discomfort throughout this procedure. The proposed&#xD;
      modification technique was selected based on a well-documented psychological phenomenon in&#xD;
      which only particular moments over the course of an aversive event determine the resultant&#xD;
      perception of the experience. It is hypothesized that implementation of the technique will&#xD;
      decrease the recalled pain intensity of the cystoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Experience rated on the visual analogue scale</measure>
    <time_frame>1 hour</time_frame>
    <description>The primary outcome of the study will be pain experience, as rated on the visual analogue scale provided.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Hematuria</condition>
  <condition>Bladder Cancer</condition>
  <condition>Bladder Disease</condition>
  <arm_group>
    <arm_group_label>Routine Cystoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified Cystoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Modified Cystoscopy</intervention_name>
    <description>The objective of this study is to examine whether a non-pharmacologic modification in procedure of cystoscopies improves patient perception of pain and discomfort.</description>
    <arm_group_label>Modified Cystoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine Cystoscopy</intervention_name>
    <description>Routine cystoscopy as done as part of routine clinical practice</description>
    <arm_group_label>Routine Cystoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 18 undergoing cystoscopy for the first time for diagnostic&#xD;
             investigation will be approached to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cystoscopies involving other interventions concurrently (e.g. biopsy, urethral&#xD;
             dilation, removal of ureteral stent, etc.) will be excluded.&#xD;
&#xD;
          -  Patients currently taking medication for chronic pain (e.g. opioids, Tricyclic&#xD;
             antidepressants (TCAs)) will be excluded from the study.&#xD;
&#xD;
          -  Patients less than 18 years of age will be excluded.&#xD;
&#xD;
          -  Patients who have received a cystoscopy previously will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas Power, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematuria</mesh_term>
    <mesh_term>Urinary Bladder Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257293
org study id: 10016740
nct id: NCT03257293
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Pain Experience rated on the visual analogue scale
time frame: 1 hour
description: The primary outcome of the study will be pain experience, as rated on the visual analogue scale provided.
arm group label: Routine Cystoscopy
arm group type: Active Comparator
arm group label: Modified Cystoscopy
arm group type: Experimental
intervention type: Behavioral
intervention name: Modified Cystoscopy
description: The objective of this study is to examine whether a non-pharmacologic modification in procedure of cystoscopies improves patient perception of pain and discomfort.
arm group label: Modified Cystoscopy
intervention type: Behavioral
intervention name: Routine Cystoscopy
description: Routine cystoscopy as done as part of routine clinical practice
arm group label: Routine Cystoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicholas Power, MD
role: Principal Investigator
affiliation: London Health Sciences Centre
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hematuria
mesh term: Urinary Bladder Diseases
sharing ipd: No