Post Hemorrhoidectomy Anorectal Pain

Effectiveness of Guided Breathing Exercises on Anorectal Pain in Patients With Symptomatic Hemorrhoids

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhoid Pain
• Intervention / Treatment: Behavioral: deep breathing exercises

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients seen in colorectal surgery clinic with planed hemorrhoid surgery

Description

Inclusion Criteria:

• Undergoing elective hemorrhoid surgery

Exclusion Criteria:

• Emergent/urgent hemorrhoid surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	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.	within ~30 days of surgery, at the time of post-operative clinic visit
Utilization of breathing exercises	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.	within ~30 days of surgery, at the time of post-operative clinic visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admissions 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.	within 30 days of surgery
Emergency Department visits 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.	within 30 days of surgery

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Study Chair: Jason Hall, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2017
• Primary Completion (ACTUAL): December 15, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (ACTUAL): August 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: pain; deep breathing; hemorrhoid; multimodal pain control
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: H-36206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No