Perineal Self-Acupressure

Study Overview
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Brief Summary
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The primary aim of this study is to test a non-medicinal technique for chronic constipation. The core of the technique is to have subjects repeatedly press on and massage their perineum before defecation to fragment and soften the stool before it passes the lower rectum and anus. The technique will be evaluated as a complementary treatment to standard treatment of constipation (patient educational materials about treatments such as stool softeners, laxatives fiber supplements, and increased exercise). Although this technique has been studied for other conditions (for example in pregnant women to prevent birthing-related injuries), and it is recommended anecdotally by some physicians, this would be the first time it will be studied for chronic constipation in a randomized, controlled clinical trial. $50 dollars in compensation is provided for about an hour of participant's time.

Official Title
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A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation

Conditions
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Chronic Constipation, Constipation, Hemorrhoids

Intervention / Treatment
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* Behavioral: Perineal Self-Acupressure
* Behavioral: Educational Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have experienced the following symptoms for at least three months: Straining during at least 25 percent of defecations Lumpy or hard stools in at least 25 percent of defecations Sensation of incomplete evacuation for at least 25 percent of defecations Sensation of anorectal obstruction/blockage for at least 25 percent of defecations Manual maneuvers to facilitate at least 25 percent of defecations (eg, digital evacuation, support of the pelvic floor) Fewer than three defecations per week Must have experienced one or more of those symptoms at least six months ago. Exclusion Criteria: Younger than 18 years old. Pregnant women. Significant weight loss (more than 10% of usual body weight in the preceding 6 months). History of blood mixed in stool.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perineal Self-Acupressure<br>Participants in this group (intervention group) will receive education in perineal self-acupressure in addition to education in conventional treatment options for constipation. | Behavioral: Perineal Self-Acupressure<br>* The core of the technique is to have subjects repeatedly press on and massage their perineum before defecation to fragment and soften the stool before it passes the lower rectum and anus.<br>|
| Active Comparator: Educational Control<br>Participants in this group (the control group) will receive education in conventional treatment options for chronic constipation. | Behavioral: Educational Control<br>* Education on conventional treatment options for chronic constipation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Constipation Quality of Life Questionnaire | Constipation related health-related quality of life by means of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Bowel Function Index and Hemorrhoid Questionnaire | A modified version of the bowel function index for patient self-completion, as well as original questions to measure change in hemorrhoid impact | 1 month | 
| SF-12 | Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2). | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic constipation, Hemorrhoids, Acupressure