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

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Drug Effect; Telerehabilitation; Pelvic Floor; Dysmenorrhea Primary; Acupressure
• Intervention / Treatment: Other: Conservative and Non-conservative treatments

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kavacık
    • Istanbul, Kavacık, Turkey, 34040
      • Gizem BOZTAŞ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: 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.
Other: 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.	Other: 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.
Experimental: Acupressure Group; 4 acupuncture points will be applied twice a day for 12 weeks. These points are; LI4, CV4, CV6, SP6 .	Other: 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.
No Intervention: Control Group; Participants will not be treated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Information Form	Participants age, height, weight, educational status, marital status, exercise habits will be recorded. In addition, sociodemographic information, clinical features such as background and family history; Information on menarche age, average cycle duration and menstruation duration, and methods of coping with dysmenorrhea were recorded.	5 minutes
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.	2 minutes
McGill Pain Questionnaire	The characteristic of pain felt by the patients during menstruation was evaluated using the McGill Pain Questionnaire-Short Form,With the McGill Melzack Pain Questionnaire, the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of viable pain for the individual are determined. High score indicates high level of pain	5 minutes
Ultrasonography (US)	Ultrasonography is a soft tissue examination method.Its biggest advantages are that it is an easily accessible method and does not contain ionizing radiation. In the evaluation by ultrasonography, dysmenorrhea due to organic problems will be evaluated and excluded by the obstetrician.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual Attitude Questionnaire	The Turkish version of the Menstrual Attitude Scale (MBI) will be applied to determine the attitudes and behaviors of the participants during the menstrual period. Menstruation attitude scale includes 5 subtitles. These subheadings are; Menstruation as a debilitating event; Menstruation as a bothersome event; Menstruation as a natural event; Ancipitation and prediction of the onset of menstruation; Denial of any effect of menstruation	5 minutes

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Gizem BOZTAŞ ELVERİŞLİ, Phd, İstanbul Medipol Üniversitesi

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Drug therapy; Telerehabilitation; Acupressure; Pelvic Floor; Dysmenorrhea Primary
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 10840098-604.01.01-E.66761

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No