Comparison of the Efficacy of Pharmacology and Non-pharmacological Treatment in Women With Primary Dysmenorrhea.

NCT ID: NCT04687852

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-09
• Study Completion Date: 2021-12-10

Brief Summary

Primary dysmenorrhea is a common problem in women. Women use many treatment methods to deal with primary dysmenorrhea. Therefore, this study aims to find the most effective treatment by determining the effectiveness of conservative and non-conservative treatment in women with primary dysmenorrhea. Another aim of the study is to generalize the use of conservative treatment methods in the treatment of primary dysmenorrhea.On the other hand, it aims to spread the telerehabilitation method, which allows the global Covid 19 outbreak to be maintained remotely online, in the world and in our country.

Detailed Description

This study aims to determine the effects of different treatment approaches in women diagnosed with primary dysmenorrhea. Patients who are examined by a physician and diagnosed with primary dysmenorrhea using ultrasonography will be included in the study. The cases will be divided into 5 groups by randomization. In the first group, patients who are prescribed diosmin by the attending physician will be taken. The second group; Patients who are prescribed naproxen sodium by the attending physician will be taken. The third group; Pelvic floor exercises will be performed 2 days a week and 12 weeks a week using the motor imagination technique created by the women health physiotherapist. In the fourth group, acupressure technique applied by applying pressure to non-invasive acupuncture points will be applied daily for 12 weeks. The fifth group will be the control group. Online access will be synchronized with the phone or computer, and training sessions will not be recorded to protect the patient's personal information. Cases will be evaluated online at the beginning of the study and at the end of the 12-week program.

Conditions

Pelvic Floor; Exercise; Telerehabilitation; Acupressure; Dysmenorrhea Primary; Drug Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Focused Pelvic Floor Exercise with Motor ImageryTechnique Group

5 minute-Meditation Therapy 10 minute-Progressive Relaxation training ( Bernstein-Borkovec Method) 5 min - Breathing Exercises (Diaphragmatic Breathing Exercise, Pursed lip breathing Exercise) 35 min -Motor Imagery Technique Focused Pelvic Floor Exercises-MOPEXE 5 min - Meditation Therapy Twice a week for 60 minutes 12 weeks Participants will be evaluated online at the beginning of the research and at the end of the 12-week program.

Group Type: EXPERIMENTAL

Conservative and Non-conservative treatments

Intervention Type: OTHER

This program includes Focused Pelvic Floor with Motor Imagery Technique Group ,Nonsteroidal Anti-Inflammatory Drug Group, Diosmin Group, Acupressure Group (LI-4 (Bilateral), CV-6, CV-4, SP-6 (Bilateral). It is aimed to determine the most effective treatment among these groups.

Nonsteroidal Anti-Inflammatory Drug(NSAID) Group

Naproxen Sodium 550 mg film-coated tablet prescribed by the physician will be given to patients. During the menstrual period, 1 or 2 times a day will be used depending on the pain of the patient. Treatment time; 12 weeks.

Group Type: ACTIVE_COMPARATOR

Conservative and Non-conservative treatments

Intervention Type: OTHER

This program includes Focused Pelvic Floor with Motor Imagery Technique Group ,Nonsteroidal Anti-Inflammatory Drug Group, Diosmin Group, Acupressure Group (LI-4 (Bilateral), CV-6, CV-4, SP-6 (Bilateral). It is aimed to determine the most effective treatment among these groups.

Diosmin Group

Diosmin (90%) 500 mg film-coated tablets prescribed by the physician will be given to patients. During the menstrual period, 1 or 2 times a day will be used depending on the patient's pain. Treatment time; 12 weeks.

Group Type: OTHER

Conservative and Non-conservative treatments

Intervention Type: OTHER

This program includes Focused Pelvic Floor with Motor Imagery Technique Group ,Nonsteroidal Anti-Inflammatory Drug Group, Diosmin Group, Acupressure Group (LI-4 (Bilateral), CV-6, CV-4, SP-6 (Bilateral). It is aimed to determine the most effective treatment among these groups.

Acupressure Group

4 acupuncture points will be applied twice a day for 12 weeks. These points are; LI4, CV4, CV6, SP6

.

Group Type: EXPERIMENTAL

Conservative and Non-conservative treatments

Intervention Type: OTHER

This program includes Focused Pelvic Floor with Motor Imagery Technique Group ,Nonsteroidal Anti-Inflammatory Drug Group, Diosmin Group, Acupressure Group (LI-4 (Bilateral), CV-6, CV-4, SP-6 (Bilateral). It is aimed to determine the most effective treatment among these groups.

Control Group

Participants will not be treated.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Conservative and Non-conservative treatments

This program includes Focused Pelvic Floor with Motor Imagery Technique Group ,Nonsteroidal Anti-Inflammatory Drug Group, Diosmin Group, Acupressure Group (LI-4 (Bilateral), CV-6, CV-4, SP-6 (Bilateral). It is aimed to determine the most effective treatment among these groups.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over the age of 18 whose menstrual cycle continues,
• Primary dysmenorrhea was diagnosed by the obstetrician by ultrasonographic evaluation.
• Participants who agree to participate in the study will be included.
• Participants in the diosmin group who were prescribed diosmin by the physician
• Participants in the NSAI group who were prescribed an NSAI by the physician

Exclusion Criteria

• Receiving hormone therapy
• Those receiving psychiatric treatment for stress disorder or anxiety
• Intrauterine contraceptive device
• Using birth control pills
• Women diagnosed with secondary dysmenorrhea
• With neurological deficits
• Patients who were not suitable for NSAI and Diosmin treatment by the physician were excluded by the physician and were not included in our study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gizem BOZTAŞ ELVERİŞLİ, Phd

Role: STUDY_DIRECTOR

Istanbul Medipol Üniversitesi

Locations

Gizem BOZTAŞ

Istanbul, Kavacık, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

10840098-604.01.01-E.66761

Identifier Type: -

Identifier Source: org_study_id