Post Hemorrhoidectomy Anorectal Pain

Hemorrhoid Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240185
• Other study ID #: H-36206
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: December 15, 2019

Study information

• Verified date: January 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing elective hemorrhoid surgery

Exclusion Criteria:

• Emergent/urgent hemorrhoid surgery

Related Conditions & MeSH terms

• Hemorrhoid Pain
• Hemorrhoids

Intervention

Behavioral:
• deep breathing exercises
Patients receive education on deep breathing exercises for pain control as part of their pre-operative appointment

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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