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| Name | Class |
|---|---|
| Yale University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineal Self-Acupressure | Experimental | Participants in this group (intervention group) will receive education in perineal self-acupressure in addition to education in conventional treatment options for constipation. |
|
| Educational Control | Active Comparator | Participants in this group (the control group) will receive education in conventional treatment options for chronic constipation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineal Self-Acupressure | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technique and Educational Material Effectiveness | Unique questions regarding use of and effectiveness of technique and educational materials. | 1 month |
Inclusion Criteria:
Must have experienced the following symptoms for at least three months:
Must have experienced one or more of those symptoms at least six months ago.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan B Abbott, MD, JD, MTOM | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for East-West Medicine | Los Angeles | California | 90024 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25403522 | Result | Abbott R, Ayres I, Hui E, Hui KK. Effect of perineal self-acupressure on constipation: a randomized controlled trial. J Gen Intern Med. 2015 Apr;30(4):434-9. doi: 10.1007/s11606-014-3084-6. Epub 2014 Nov 18. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
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| Educational Control | Behavioral | Education on conventional treatment options for chronic constipation. |
|
Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2).
| 1 month |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |