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Magnetic Reflexologic Insoles for Primary Dysmenorrhea

Investigation of the Effectiveness of Reflexologic Magnetic Insoles on Dysmenorrhea Symptoms in Primary Dysmenorrhea

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06383312
Enrollment
60
Registered
2024-04-25
Start date
2024-05-31
Completion date
2024-09-30
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea, Reflexology, Pain, Foot Orthoses

Brief summary

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

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.

Interventions

DEVICEReflexologic 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.

DEVICEOrthopedic 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.

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

two groups; treatment group and sham group

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
McGill Pain Questionnaire-Short Form:12 weeksIt 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.
Menstruation Attitude Questionnaire12 weeksValuated 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.
Menstruation Symptom Questionnaire12 weeksIt 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.
Visual Analogue Scale (VAS)12 weeksThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactGizem BOZTAŞ ELVERİŞLİ, Ph.D
gboztas@medipol.edu.tr5439076494
Backup ContactMuhammed Çağrı ELVERİŞLİ, M.D
muhammedelverisli@gmail.com5537165614

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026