Magnetic Reflexologic Insoles for Primary Dysmenorrhea

Not Applicable

Not yet recruiting

• Conditions: Primary Dysmenorrhea
• Interventions: Device: Reflexologic Magnetic Insole Group; Device: Orthopedic Insole Group

• Registration Number: NCT06383312
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-06
• Study First Submitted QC: 2024-04-20
• Last Update Submitted: 2024-04-20
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Study Start: 2024-05
• Primary Completion: 2024-08
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reflexologic Magnetic Insoles Group	Reflexologic Magnetic Insole Group	Participants will place the insoles inside their shoes and use them for at least 7 hours a day, every day, for 12 weeks.
Orthopedic Insoles Group	Orthopedic Insole Group	Participants will place the insoles inside their shoes and use them for at least 7 hours a day, every day, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	12 weeks	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.
McGill Pain Questionnaire-Short Form:	12 weeks	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.
Menstruation Attitude Questionnaire	12 weeks	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.
Menstruation Symptom Questionnaire	12 weeks	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.

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 Istanbul, Turkey