Magnetic Reflexologic Insoles for Primary Dysmenorrhea

Medipol Health Group

Status: Not yet enrolling

Conditions: Primary Dysmenorrhea

Treatments: Device: Orthopedic Insole Group; Device: Reflexologic Magnetic Insole Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06383312

E-10840098-772.02-4248

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having been diagnosed with primary dysmenorrhea
• Visual Analogue Scale (VAS) value is 3 and above
• The patient has cooperation
• Having regular menstruation

Exclusion criteria

• Getting pregnant during treatment
• Using analgesic medication
• Visual Analogue Scale (VAS) value should be between 0-3
• Having pain in another part of the body

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Reflexologic Magnetic Insoles Group

Active Comparator group

Description:

Participants will place the insoles inside their shoes and use them for at least 7 hours a day, every day, for 12 weeks.

Treatment:

Device: Reflexologic Magnetic Insole Group

Orthopedic Insoles Group

Sham Comparator group

Description:

Participants will place the insoles inside their shoes and use them for at least 7 hours a day, every day, for 12 weeks.

Treatment:

Device: Orthopedic Insole Group