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Completed

NCT Number: NCT03240185

Post Hemorrhoidectomy Anorectal Pain

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing elective hemorrhoid surgery

Exclusion criteria

  • Emergent/urgent hemorrhoid surgery

Treatment and study plan

Deep Breathing Exercises

Behavioral

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

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2017
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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