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

Primary Purpose

Pelvic Floor, Exercise, Telerehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conservative and Non-conservative treatments
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor focused on measuring Pelvic Floor, Dysmenorrhea Primary, Drug therapy, Telerehabilitation, Acupressure

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Gizem BOZTAŞ

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Other

Experimental

No Intervention

Arm Label

Focused Pelvic Floor Exercise with Motor ImageryTechnique Group

Nonsteroidal Anti-Inflammatory Drug(NSAID) Group

Diosmin Group

Acupressure Group

Control Group

Arm Description

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.

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.

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.

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

Participants will not be treated.

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2020
Last Updated
May 23, 2022
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04687852
Brief Title
Comparison of the Efficacy of Pharmacology and Non-pharmacological Treatment in Women With Primary Dysmenorrhea.
Official Title
Comparison of the Efficacy of Pharmacology and Non-pharmacological Treatment in Women With Primary Dysmenorrhea.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor, Exercise, Telerehabilitation, Acupressure, Dysmenorrhea Primary, Drug Effect
Keywords
Pelvic Floor, Dysmenorrhea Primary, Drug therapy, Telerehabilitation, Acupressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focused Pelvic Floor Exercise with Motor ImageryTechnique Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Nonsteroidal Anti-Inflammatory Drug(NSAID) Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diosmin Group
Arm Type
Other
Arm Description
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.
Arm Title
Acupressure Group
Arm Type
Experimental
Arm Description
4 acupuncture points will be applied twice a day for 12 weeks. These points are; LI4, CV4, CV6, SP6 .
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will not be treated.
Intervention Type
Other
Intervention Name(s)
Conservative and Non-conservative treatments
Intervention Description
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.
Primary Outcome Measure Information:
Title
Demographic Information Form
Description
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.
Time Frame
5 minutes
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
2 minutes
Title
McGill Pain Questionnaire
Description
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
Time Frame
5 minutes
Title
Ultrasonography (US)
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Menstrual Attitude Questionnaire
Description
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
Time Frame
5 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gizem BOZTAŞ ELVERİŞLİ, Phd
Organizational Affiliation
Istanbul Medipol Üniversitesi
Official's Role
Study Director
Facility Information:
Facility Name
Gizem BOZTAŞ
City
Istanbul
State/Province
Kavacık
ZIP/Postal Code
34040
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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