Post Hemorrhoidectomy Anorectal Pain

Completed

• Conditions: Hemorrhoid Pain
• Interventions: Behavioral: deep breathing exercises

• Registration Number: NCT03240185
• Lead Sponsor: Boston Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2017-10-02
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Undergoing elective hemorrhoid surgery

Exclusion Criteria

• Emergent/urgent hemorrhoid surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemroidectomy patients	deep breathing exercises	Patients undergoing hemorrhoid surgery who receive education regarding deep breathing exercises for pain control as part of their preoperative appointment

Primary Outcome Measures

Name	Time	Method
Pain scores	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	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

Name	Time	Method
Emergency Department visits within 30 Days of Surgery	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.
Admissions within 30 Days of Surgery	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.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States