Chronic Constipation, Constipation, Hemorrhoids
Conditions
Keywords
Chronic constipation, Hemorrhoids, Acupressure
Brief summary
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.
Interventions
BEHAVIORALPerineal Self-Acupressure
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.
BEHAVIORALEducational Control
Education on conventional treatment options for chronic constipation.
Sponsors
Yale University
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Constipation Quality of Life Questionnaire | 1 month | Constipation related health-related quality of life by means of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Bowel Function Index and Hemorrhoid Questionnaire | 1 month | A modified version of the bowel function index for patient self-completion, as well as original questions to measure change in hemorrhoid impact |
| SF-12 | 1 month | Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Technique and Educational Material Effectiveness | 1 month | Unique questions regarding use of and effectiveness of technique and educational materials. |
Countries
United States
Outcome results
None listed