Magnetic Reflexologic Insoles for Primary Dysmenorrhea

April 20, 2024 updated by: gizem boztas, Istanbul Medipol University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34815
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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.
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
McGill Pain Questionnaire-Short Form:
Time Frame: 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.
12 weeks
Menstruation Attitude Questionnaire
Time Frame: 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.
12 weeks
Menstruation Symptom Questionnaire
Time Frame: 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.
12 weeks
Visual Analogue Scale (VAS)
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Investigators

  • Study Director: Gizem BOZTAŞ ELVERİŞLİ, Ph.D, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 6, 2024

First Submitted That Met QC Criteria

April 20, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 20, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-772.02-4248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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