Magnetic Reflexologic Insoles for Primary Dysmenorrhea

NCT06383312 | Not Yet Recruiting

• 1 other identifier: E-10840098-772.02-4248
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Dysmenorrhea; Reflexology; Pain; Foot Orthoses

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Device: Reflexologic Magnetic Insole Group

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.

Device: Orthopedic Insole Group

Interventions

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.

Reflexologic Magnetic Insoles Group

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.

Orthopedic Insoles Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Since dysmenorrhea is a problem seen in the menstrual cycle in women, female participants will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea; Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Gizem BOZTAŞ ELVERİŞLİ, Ph.D

  Medipol University

  STUDY DIRECTOR

Central Study Contacts

Gizem BOZTAŞ ELVERİŞLİ, Ph.D

CONTACT

5439076494; gboztas@medipol.edu.tr

Muhammed Çağrı ELVERİŞLİ, M.D

CONTACT

5537165614; muhammedelverisli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: two groups; treatment group and sham group

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 25, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)