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

M

Medipol Health Group

Status

Completed

Conditions

Pelvic Floor
Telerehabilitation
Acupressure
Drug Effect
Dysmenorrhea Primary
Exercise

Treatments

Other: Conservative and Non-conservative treatments

Study type

Interventional

Funder types

Other

Identifiers

NCT04687852
10840098-604.01.01-E.66761

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

85 participants in 5 patient groups

Focused Pelvic Floor Exercise with Motor ImageryTechnique Group
Experimental group
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.
Treatment:
Other: Conservative and Non-conservative treatments
Nonsteroidal Anti-Inflammatory Drug(NSAID) Group
Active Comparator group
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.
Treatment:
Other: Conservative and Non-conservative treatments
Diosmin Group
Other group
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.
Treatment:
Other: Conservative and Non-conservative treatments
Acupressure Group
Experimental group
Description:
4 acupuncture points will be applied twice a day for 12 weeks. These points are; LI4, CV4, CV6, SP6 .
Treatment:
Other: Conservative and Non-conservative treatments
Control Group
No Intervention group
Description:
Participants will not be treated.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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