The purpose of the research project is to develop and test the safety and effectiveness of a proprietary (U.S. patent pending) acupressure garment (the Relief Brief) in decreasing the pain and symptom distress associated with dysmenorrhea.
The specific aims of this clinical trial, with women who experience moderately severe dysmenorrhea, are (1) to determine the effectiveness of the Relief Brief aimed at reducing symptom severity and pain intensity measures. The following hypothesis will be tested: the Relief Brief group will have statistically and clinically significant effects in reducing menstrual symptom severity, pain intensity, and ibuprofen use across a baseline and two treatment menstrual cycles compared to the control group; and (2) To determine the ease of use and any adverse effects associated with using the Relief Brief. Seventy healthy menstruating women who meet dysmenorrhea criteria will be randomized to a treatment group (Relief Brief) or control group after 1 baseline menstrual cycle. We are requesting GCRC support for approximately 210 outpatient visits over 4-5 months beginning in late 1998. Nursing services are requested for administration of questionnaires, implementation of the intervention, vital sign monitoring, and patient teaching. GCRC database services are requested for assistance in the development of data-entry and data-management systems. GCRC support will allow for a larger sample size as well as an additional treatment cycle. The GCRC will also allow for greater flexibility in scheduling outpatient visits.
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