Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

Research on 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 Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: Device: Nanoone Woman Underwear

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Pingtung, Taiwan
    • Pingtung Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Females aged below 40 years old.
2. Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic ultrasonography.

3. Female subject who is:

   • using adequate contraception since last menstruation and no plan for conception during the study.
   • non-lactating.
   • has negative pregnancy test (urine) within 14 days prior to the study.
4. Informed consent form signed.

Exclusion Criteria:

1. Sensitivity to study product.
2. Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic pathology).
3. Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co-investigator.
4. Participation of any clinical investigation during the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline	The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).	baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medicine Administration for Pain Relief During Study Period	Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.	first menstrual cycle, second menstrual cycle and third menstrual cycle

Collaborators and Investigators

• Sponsor: Chen Yi Enterprise, Co., Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 7, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Estimate): February 4, 2013
• Last Update Submitted That Met QC Criteria: February 1, 2013
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: Nanoone