Post Hemorrhoidectomy Anorectal Pain

NCT03240185 | Completed

• 1 other identifier: H-36206
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoid Pain

Keywords

hemorrhoid; pain; deep breathing; multimodal pain control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Admissions within 30 Days of Surgery

  within 30 days of surgery

• Emergency Department visits within 30 Days of Surgery

  within 30 days of surgery

Study Arms (1)

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

Interventions

deep breathing exercises BEHAVIORAL

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

Hemroidectomy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in colorectal surgery clinic with planed hemorrhoid surgery

You may qualify if:

• Undergoing elective hemorrhoid surgery

You may not qualify if:

• Emergent/urgent hemorrhoid surgery

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Hemorrhoids; Pain

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason Hall, MD

  Boston Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: August 7, 2017
• Study Start: October 2, 2017
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)