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In the study, easy-to-access and easy-to-use reflexologic magnetic insoles were used in women with primary dysmenorrhea who did not want to receive medical treatment; In addition to reducing symptoms such as pain, nausea, dizziness, fainting, vomiting, weakness, constipation/acute gastroenteritis, it is aimed to increase individuals' participation in daily life activities and increase their quality of life by increasing their emotional state.
60 women diagnosed with primary dysmenorrhea through examination by a gynecologist will be included in the study. 60 women will be randomly divided into 2 groups. These groups; Reflexologic Magnetic Insoles Sham Group: They will use orthopedic insoles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reflexologic Magnetic Insoles Group | Active Comparator | Participants will place the insoles inside their shoes and use them for at least 7 hours a day, every day, for 12 weeks. |
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| Orthopedic Insoles Group | Sham Comparator | Participants will place the insoles inside their shoes and use them for at least 7 hours a day, every day, for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflexologic Magnetic Insole Group | Device | Reflexologic magnetic insole will be used for at least 7 hours a day, every day, for 12 weeks in participants diagnosed with primary dysmenorrhea. Then the effectiveness of the insoles will be compared. |
| Measure | Description | Time Frame |
|---|---|---|
| McGill Pain Questionnaire-Short Form: | It evaluates the sensory dimension of pain and the affective dimension of pain. Affective and sensory dimension scores of pain are measured with a Likert-type scale (0-No pain, 3-Severe Pain). The total pain dimension subparametric is the sum of the sensory dimension and the affective dimension of the pain. Total pain intensity is measured with a 6-point Likert-type scale (0-No pain, 5-Unbearable Pain). A high score indicates a high level of pain. | 12 weeks |
| Menstruation Attitude Questionnaire | Valuated subdimensions include menstruation as a deliberating event, menstruating as a bothersome event, menstruation as a natural event, anticipation and prediction of the onset of menstruation, and denial of any effects of menstruation. The scale is evaluated with a 5-point Likert-type." A high mean score indicates a "positive" attitude toward menstruation. | 12 weeks |
| Menstruation Symptom Questionnaire | It contains 24 items. It is a 5-point Likert type scale. Participants are asked to evaluate the symptoms that occur during menstruation as a-never (1), b-rarely (2), c-sometimes (3), d-often (4) and e-always (5). The overall score of the scale is calculated by taking the average of the total score obtained from the scale items. A higher score indicates that the symptoms are experienced more clearly. | 12 weeks |
| Visual Analogue Scale (VAS) | The Visual Analogue Scale (VAS) is used to convert non-numerical values to digital. The value 0 means I have no pain, 10 means I have unbearable pain. The person marks his pain on this ruler. It measures the intensity of the pain. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Since dysmenorrhea is a problem seen in the menstrual cycle in women, female participants will be included in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gizem BOZTAŞ ELVERİŞLİ, Ph.D | Contact | 5439076494 | gboztas@medipol.edu.tr | |
| Muhammed Çağrı ELVERİŞLİ, M.D | Contact | 5537165614 | muhammedelverisli@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gizem BOZTAŞ ELVERİŞLİ, Ph.D | Medipol University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Istanbul | 34815 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D010146 | Pain |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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two groups; treatment group and sham group
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| Orthopedic Insole Group | Device | Orthopedic insole (sham) will be used for at least 7 hours a day, every day, for 12 weeks in participants diagnosed with primary dysmenorrhea. Then the effectiveness of the insoles will be compared. |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |