Magnetic Reflexologic Insoles for Primary Dysmenorrhea

NCT ID: NCT06383312

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups; treatment group and sham group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reflexologic Magnetic Insoles Group

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

Group Type ACTIVE_COMPARATOR

Reflexologic Magnetic Insole Group

Intervention Type 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.

Orthopedic Insoles Group

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

Group Type SHAM_COMPARATOR

Orthopedic Insole Group

Intervention Type 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.

Interventions

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Reflexologic Magnetic Insole Group

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.

Intervention Type DEVICE

Orthopedic Insole Group

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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gizem boztas

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gizem BOZTAŞ ELVERİŞLİ, Ph.D

Role: STUDY_DIRECTOR

Medipol University

Locations

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Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Gizem BOZTAŞ ELVERİŞLİ, Ph.D

Role: CONTACT

5439076494

Muhammed Çağrı ELVERİŞLİ, M.D

Role: CONTACT

5537165614

Other Identifiers

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E-10840098-772.02-4248

Identifier Type: -

Identifier Source: org_study_id

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