This study is looking to test a non-compressive semiconductor embedded body sleeve for treatment of primary dysmenorrhea symptoms. Dysmenorrhea is the lower abdominal pain (sometimes referred to as "cramping") experienced during menstruation (monthly "period"), affecting up to 94% of people aged from 10-20 years old. The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases energy waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for menstrual cramping.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
The active device contains semiconductors embedded into the body sleeve fabric
Identical body sleeve absent of semiconductors
Participant-Reported Changes in Pain
Reduction in menstrual symptom severity as determined by the Visual Analog Scale (VAS) compared to placebo group: Visual Analog Scale for Pain (VAS) Minimum value: 0 (no pain) Maximum value: 10 (worst possible pain)
Time frame: 6 months
Participant-Reported Changes in Quality of Life
Improvement in health-related quality of life as determined by the Short Form quality of life enjoyment and satisfaction questionnaire (Q-LES-Q-SF) compared to placebo group. Q-LES-Q-SF: Lowest score: 14 (indicating very poor quality of life) Highest score: 70 (indicating very good quality of life)
Time frame: 6 months
Changes in oral medication intake compared to placebo group
As measured by collecting concomitant medication information at baseline and changes throughout participation in the study.
Time frame: 6 months
Changes in Participant Pain Score (SF-MPQ-2)
Changes in participant menstrual pain as determined by menstrual pain questionnaire, Short Form McGill Pain Questionnaire (SF-MPQ-2), compared to placebo group. SF-MPQ-2: Lowest score: 0 (no pain) Highest score: 10 (worst possible pain)
Time frame: 6 months
Changes in participant function in daily life
Changes in participant function/distress as determined by Menstrual Distress Questionnaire (MEDI-Q), compared to placebo group. MEDI-Q: Lowest score: 0 (no distress) Highest score: 5 (very much distress)
Time frame: 6 months
Changes in menstrual symptom duration
Changes in menstrual symptom duration compared to placebo group as reported by participants at each menstrual cycle.
Time frame: 6 months
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