Hemorrhoid PainNCT03240185
Post Hemorrhoidectomy Anorectal Pain
An observational study of Hemorrhoid Pain, run by Boston Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoid Pain
- What is being tested?
- deep breathing exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2017to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seen in colorectal surgery clinic with planed hemorrhoid surgery
Who may be able to join
- Undergoing elective hemorrhoid surgery
Who cannot join
- Emergent/urgent hemorrhoid surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemorrhoid Pain
- Being tested
- deep breathing exercises
- Keywords
- hemorrhoid, pain, deep breathing, multimodal pain control
- Medical subject headings
- Hemorrhoids, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep breathing exercisesBehavioural
Patients receive education on deep breathing exercises for pain control as part of their pre-operative appointment
| Study group | Role | What they receive |
|---|---|---|
| Hemroidectomy patients | Patients undergoing hemorrhoid surgery who receive education regarding deep breathing exercises for pain control as part of their preoperative appointment Receives: Behavioral: deep breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within ~30 days of surgery, at the time of post-operative clinic visit
Secondary outcomes (2)
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.
Measured: 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.
Measured: within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start2 Oct 2017
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoid PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Hall, MD, Study chair, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240185
- Sponsor's protocol ID
- H-36206
- Status last verified
- Jan 2020
- First submitted
- 20 Jul 2017
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Guided Breathing Exercises on Anorectal Pain in Patients With Symptomatic Hemorrhoids
- ClinicalTrials.gov ID
- NCT03240185
- Acronym / sponsor ID
- H-36206
- Conditions
- Hemorrhoid Pain
- Keywords
- hemorrhoid, pain, deep breathing, multimodal pain control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemroidectomy patients | – | Behavioral: deep breathing exercisesPatients undergoing hemorrhoid surgery who receive education regarding deep breathing exercises for pain control as part of their preoperative appointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in colorectal surgery clinic with planed hemorrhoid surgery
Key inclusion criteria (1 listed)
- Undergoing elective hemorrhoid surgery
Key exclusion criteria (1 listed)
- Emergent/urgent hemorrhoid surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep breathing exercisesPatients receive education on deep breathing exercises for pain control as part of their pre-operative appointment | Behavioural | Hemroidectomy patients |
Primary outcome
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.
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.
2 secondary outcomes
Admissions within 30 Days of Surgery
Time frame: within 30 days of surgery
Emergency Department visits within 30 Days of Surgery
Time frame: within 30 days of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoid Pain
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Laser Hemorrhoidoplasty Versus Open Hemorrhoidectomy for Postoperative Pain
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Sutureless Hemorrhoidectomy Versus Conventional Ligation in Advanced Hemorrhoids
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Pudendal Nerve Block Techniques for Pain Control After Hemorrhoidectomy
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HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Hemorrhoids Third Degree, Internal Hemorrhoids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Hall, MD study chair
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoid Pain, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: within ~30 days of surgery, at the time of post-operative clinic visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.