<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/NCT03240185</url>
  </required_header>
  <id_info>
    <org_study_id>H-36206</org_study_id>
    <nct_id>NCT03240185</nct_id>
  </id_info>
  <brief_title>Post Hemorrhoidectomy Anorectal Pain</brief_title>
  <official_title>Effectiveness of Guided Breathing Exercises on Anorectal Pain in Patients With Symptomatic Hemorrhoids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Center</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>
      This is a quality assurance trial to evaluate the effectiveness of guided breathing exercises&#xD;
      on reducing the symptoms of hemorrhoidal disease in colorectal surgery patients. All patients&#xD;
      who undergo hemorrhoid surgery are educated on breathing exercises that can be used to reduce&#xD;
      pain and increase relaxation. These patients will be surveyed at their post-operative visit&#xD;
      regarding pain and other symptoms and at their one month post operative visit on the any&#xD;
      hospitalizations and emergency room visits since their surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effectiveness of guided breathing exercises on reducing the symptoms of hemorrhoidal&#xD;
      disease in colorectal surgery patients will be assessed in this quality assurance trial.&#xD;
      During the pre-operative clinic visit, patients to undergo hemorrhoid surgery are educated on&#xD;
      breathing exercises that can be used to reduce pain and increase relaxation. In this year&#xD;
      long study patient self-reported utilization of the breathing exercises and their level of&#xD;
      pain, sleep quality, gastrointestinal symptoms (diarrhea, constipation, etc), emergency room&#xD;
      visits, and hospitalizations in the month post hemorrhoid surgery will be evaluated. All&#xD;
      patients will be asked to complete a brief survey at their pre-operative and one month&#xD;
      post-operative visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain scores</measure>
    <time_frame>within ~30 days of surgery, at the time of post-operative clinic visit</time_frame>
    <description>The Wong-Baker faces pain score scale which displays 6 faces with scores of 0, 2, 4, 6, 8, 10, where 0=no hurt and 10=worst hurt will be used in the pre-operative and post-operative surveys to assess each patient's self reported pain level. the lower the score the more favorable/less pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Utilization of breathing exercises</measure>
    <time_frame>within ~30 days of surgery, at the time of post-operative clinic visit</time_frame>
    <description>Response to two questions in the post-operative survey will be used to assess wehether the patient did the breathing exercises after surgery (yes or no) and if they did how man times daily did they do the breathing exercises- &lt;2, 3-5, or &gt;5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Admissions within 30 Days of Surgery</measure>
    <time_frame>within 30 days of surgery</time_frame>
    <description>The number of patients who required admission for pain control/infection/bleeding/other complication within 30 days of surgery will be determined from a review of the medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency Department visits within 30 Days of Surgery</measure>
    <time_frame>within 30 days of surgery</time_frame>
    <description>Evaluating number of patients who visited the Emergency Department within 30 days of surgery will be determined from a review of the medical records.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Hemorrhoid Pain</condition>
  <arm_group>
    <arm_group_label>Hemroidectomy patients</arm_group_label>
    <description>Patients undergoing hemorrhoid surgery who receive education regarding deep breathing exercises for pain control as part of their preoperative appointment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>deep breathing exercises</intervention_name>
    <description>Patients receive education on deep breathing exercises for pain control as part of their pre-operative appointment</description>
    <arm_group_label>Hemroidectomy patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients seen in colorectal surgery clinic with planed hemorrhoid surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing elective hemorrhoid surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergent/urgent hemorrhoid surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Hall, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>January 2, 2020</last_update_submitted>
  <last_update_submitted_qc>January 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hemorrhoid</keyword>
  <keyword>pain</keyword>
  <keyword>deep breathing</keyword>
  <keyword>multimodal pain control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</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/NCT03240185
org study id: H-36206
nct id: NCT03240185
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a quality assurance trial to evaluate the effectiveness of guided breathing exercises
      on reducing the symptoms of hemorrhoidal disease in colorectal surgery patients. All patients
      who undergo hemorrhoid surgery are educated on breathing exercises that can be used to reduce
      pain and increase relaxation. These patients will be surveyed at their post-operative visit
      regarding pain and other symptoms and at their one month post operative visit on the any
      hospitalizations and emergency room visits since their surgery.
The effectiveness of guided breathing exercises on reducing the symptoms of hemorrhoidal
      disease in colorectal surgery patients will be assessed in this quality assurance trial.
      During the pre-operative clinic visit, patients to undergo hemorrhoid surgery are educated on
      breathing exercises that can be used to reduce pain and increase relaxation. In this year
      long study patient self-reported utilization of the breathing exercises and their level of
      pain, sleep quality, gastrointestinal symptoms (diarrhea, constipation, etc), emergency room
      visits, and hospitalizations in the month post hemorrhoid surgery will be evaluated. All
      patients will be asked to complete a brief survey at their pre-operative and one month
      post-operative visits.
observational model: Cohort
time perspective: Prospective
measure: Pain scores
time frame: within ~30 days of surgery, at the time of post-operative clinic visit
description: The Wong-Baker faces pain score scale which displays 6 faces with scores of 0, 2, 4, 6, 8, 10, where 0=no hurt and 10=worst hurt will be used in the pre-operative and post-operative surveys to assess each patient's self reported pain level. the lower the score the more favorable/less pain.
measure: Utilization of breathing exercises
time frame: within ~30 days of surgery, at the time of post-operative clinic visit
description: Response to two questions in the post-operative survey will be used to assess wehether the patient did the breathing exercises after surgery (yes or no) and if they did how man times daily did they do the breathing exercises- <2, 3-5, or >5.
measure: Admissions within 30 Days of Surgery
time frame: within 30 days of surgery
description: The number of patients who required admission for pain control/infection/bleeding/other complication within 30 days of surgery will be determined from a review of the medical records.
measure: Emergency Department visits within 30 Days of Surgery
time frame: within 30 days of surgery
description: Evaluating number of patients who visited the Emergency Department within 30 days of surgery will be determined from a review of the medical records.
arm group label: Hemroidectomy patients
description: Patients undergoing hemorrhoid surgery who receive education regarding deep breathing exercises for pain control as part of their preoperative appointment
intervention type: Behavioral
intervention name: deep breathing exercises
description: Patients receive education on deep breathing exercises for pain control as part of their pre-operative appointment
arm group label: Hemroidectomy patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jason Hall, MD
role: Study Chair
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hemorrhoids
sharing ipd: No