Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Research on Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea|
- The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline [ Time Frame: baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle ] [ Designated as safety issue: No ]The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).
- Medicine Administration for Pain Relief During Study Period [ Time Frame: first menstrual cycle, second menstrual cycle and third menstrual cycle ] [ Designated as safety issue: No ]Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.
|Study Start Date:||October 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Nanoone Woman Underwear
"Nanoone" negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body.
Device: Nanoone Woman Underwear
Chen Yi Enterprise, Co., Ltd. design a kind of negative ion materials can supply delocalized electron, and add fiber inside, make clothes to wear in the body, no external power or battery, only depend on infrared body photon hit of thermoelectric effect or heart compression pulse, blood flow of piezoelectric, therefore can sustained sufficient amount of effective negative ion, to eliminate positive ions in vivo, or make oxygen free radical to obtain the lack electrons. Decrease active free radical and get non toxic effect in short time.
The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain). Subjects will be asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449305
|PingTung Christian Hospital|