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Post Hemorrhoidectomy Anorectal Pain

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03240185
First Posted: August 7, 2017
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephanie Talutis, Boston Medical Center
  Purpose
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.

Condition Intervention
Hemorrhoid Pain Behavioral: deep breathing exercises

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Guided Breathing Exercises on Anorectal Pain in Patients With Symptomatic Hemorrhoids

Resource links provided by NLM:


Further study details as provided by Stephanie Talutis, Boston Medical Center:

Primary Outcome Measures:
  • Pain scores [ Time Frame: within ~30 days of surgery, at the time of post-operative clinic visit ]
    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.

  • Utilization of breathing exercises [ Time Frame: within ~30 days of surgery, at the time of post-operative clinic visit ]
    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.


Secondary Outcome Measures:
  • Admissions within 30 Days of Surgery [ Time Frame: within 30 days of surgery ]
    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.

  • Emergency Department visits within 30 Days of Surgery [ Time Frame: within 30 days of surgery ]
    Evaluating number of patients who visited the Emergency Department within 30 days of surgery will be determined from a review of the medical records.


Estimated Enrollment: 200
Actual Study Start Date: October 2, 2017
Estimated Study Completion Date: October 1, 2018
Estimated Primary Completion Date: October 1, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hemroidectomy patients
Patients undergoing hemorrhoid surgery who receive education regarding deep breathing exercises for pain control as part of their preoperative appointment
Behavioral: deep breathing exercises
Patients receive education on deep breathing exercises for pain control as part of their pre-operative appointment

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in colorectal surgery clinic with planed hemorrhoid surgery
Criteria

Inclusion Criteria:

  • Undergoing elective hemorrhoid surgery

Exclusion Criteria:

  • Emergent/urgent hemorrhoid surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240185


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Study Director: Angela Kuhnen, MD Boston Medical Center
Study Chair: Jason Hall, MD MPH Boston Medical Center
  More Information

Responsible Party: Stephanie Talutis, PGY 3 Surgery Resident, Boston Medical Center
ClinicalTrials.gov Identifier: NCT03240185     History of Changes
Other Study ID Numbers: H-36206
First Submitted: July 20, 2017
First Posted: August 7, 2017
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephanie Talutis, Boston Medical Center:
hemorrhoid
pain
deep breathing
multimodal pain control

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases