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

NCT04687852 | Completed

• 1 other identifier: 10840098-604.01.01-E.66761
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pelvic Floor; Dysmenorrhea Primary; Drug therapy; Telerehabilitation; Acupressure

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Menstrual Attitude Questionnaire

  5 minutes

Study Arms (5)

Focused Pelvic Floor Exercise with Motor ImageryTechnique Group

EXPERIMENTAL

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

Nonsteroidal Anti-Inflammatory Drug(NSAID) Group

ACTIVE COMPARATOR

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

Diosmin Group

OTHER

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

Acupressure Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants will not be treated.

Interventions

Conservative and Non-conservative treatments 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; Diosmin Group; Focused Pelvic Floor Exercise with Motor ImageryTechnique Group; Nonsteroidal Anti-Inflammatory Drug(NSAID) Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Gizem BOZTAŞ

Istanbul, Kavacık, 34040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Gizem BOZTAŞ ELVERİŞLİ, Phd

  Istanbul Medipol Üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 29, 2020
• Study Start: July 9, 2021
• Primary Completion: December 9, 2021
• Study Completion: December 10, 2021
• Last Updated: May 24, 2022

Record last verified: 2021-06

Locations

TU (1)