Clinical trial NCT03625375: Effects of Combined Exercises on Primary Dysmenorrhea
Official title: Effects of Combined Exercises on Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: exercise
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dysmenorrhea is one of the most common gynecological problem in adolescents and young women. Symptoms of dysmenorrhea include pelvic / abdominal pain, back pain, headache, nausea, vomiting, diarrhea. These symptoms occur before menstrual bleeding or with bleeding and lasts in 12-74 hours. The objective of this study to investigate the effects of combined exercises on dysmenorrhea symptoms. Exercise protocol aerobic, stretching, kegels, pelvic motions and relaxation exercises.

Detailed description: Women with a positive primary dysmenorrhoea symptom between 18 and 30 years of age living in the Turkish Republic of Northern Cyprus will be included in the study. According to the result of the power analysis, 14 subjet for control and 14subjet intervention group were decided.

The eligibility criteria for this study are:

* The Visual Analogue Scale value is at least 5 per day when the dysmenorrhea symptoms are the most painful,
* To have the regular menstrual cycle (24-35 days),
* To be sedentary

The exclusion criteria for this study are:

* Women with secondary dysmenorrhea,
* The women who gave birth or abortion,
* People with active sexual experience,
* Women who use intrauterine devices,
* Individuals with regular drug use,
* Serious psychological problems
* Acute musculoskeletal problems,
* People with neurological or cardiopulmonary disease

This research will consist of exercise and control groups. An exercise protocol consisting of a combination of various exercises will be applied to the exercise group and no exercises will be done for the control group. women in the exercise group will perform two menstrual cycles, three times a week in the presence of a physiotherapist.

Assessments will be made on the day that the symptoms are seen to be the most severe in order to determine the symptoms of the women in both groups. After baseline assements exercises will start at 3rd day of cycle. Assesments will repeat at second and third menstrual bleedings.

Visual Analogue Scale, Menstrual symptom questionnarie and Pittsburgh Sleep Quality Index will be use.

Eligibility criteria: Inclusion Criteria:

* The Visual Analogue Scale value is at least 5 per day when the dysmenorrhea symptoms are the most painful,
* To have the regular menstrual cycle (24-35 days),
* Being a sedentary (not participating in any regular exercise program).

Exclusion Criteria:

* Women with secondary dysmenorrhea,
* The women who gave birth or abortion,
* People with active sexual experience,
* Women who use intrauterine devices,
* Individuals with regular drug use,
* Serious psychological problems
* Acute musculoskeletal problems,
* People with neurological or cardiopulmonary disease.

Primary outcomes:
measure: pain changes from baseline to 8 weeks
timeFrame: To asses pain level changes in this study assement make at baseline and repeat after 1 and 2 months
Secondary outcomes:
measure: menstrual symptoms changes from baseline to 8 weeks
timeFrame: At baseline, after 4 weeks from baseline and 8 weeks after baseline
measure: sleep quality changes from baseline to 8 weeks
timeFrame: At baseline of the study, after 4 weeks from baseline and 8 weeks after baseline
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Meditteranean University
name: Berkiye Kırmızıgil
role: STUDY_DIRECTOR
References:
citation: Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.