Clinical trial NCT04687852: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor
Exercise
Telerehabilitation
Acupressure
Dysmenorrhea Primary
Drug Effect
Keywords: Pelvic Floor
Dysmenorrhea Primary
Drug therapy
Telerehabilitation
Acupressure
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Demographic Information Form
timeFrame: 5 minutes
measure: Visual Analogue Scale (VAS)
timeFrame: 2 minutes
measure: McGill Pain Questionnaire
timeFrame: 5 minutes
measure: Ultrasonography (US)
timeFrame: 5 minutes
Secondary outcomes:
measure: Menstrual Attitude Questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gizem BOZTAŞ
state: Kavacık
Study officials:
affiliation: Istanbul Medipol Üniversitesi
name: Gizem BOZTAŞ ELVERİŞLİ, Phd
role: STUDY_DIRECTOR
References: