Effect of Exercise on Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Effect of Exercise on Pain and Qulity of Life on People in Primary Dysmenorrhea Complaints

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04451629
• Other study ID #: NEU
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: January 30, 2021

Study information

• Verified date: June 2020
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dismenored that menstruation is painful enough to interfere with the normal activity of the individual and require drug use. Dysmenorrhea is a localized pain in the lower abdominal quadrant and may spread to the back, waist, groin and vulva. This periodic pain may be accompanied by GIS complaints such as nausea, vomiting and frequent defecation, headache, emotional disorders and palpitations. Primary dysmenorrhea manifests itself as painful cramps in the lower part of the abdomen during the menstruation period without a pelvic pathology (endometriosis, pelvic adhesion or uterine fibroids, etc.). Menstrual problems affect 75% of adolescent girls and cause widespread medical treatment. The prevalence of primary dysmenorrhea in adolescents is significantly high, which is reported to be a major public health problem requiring attention. When Dysmenorrhea prevalence by examining the situation regarding in Turkey is noteworthy that dysmenorrhea prevalence in the 34-% 89.6% range. Non-drug applications are frequently used in the management of primary dysmenorrhea . Often, exercise is seen as an important method among these practices. Often, exercise is seen as an important method among these practices.

It has been reported that the effect of regular exercise on dysmenorrhea may be due to the effect of hormonal changes on the epithelial tissue of the uterus or an increase in endorphin levels, and it is concluded that dysmenorrhea reduces symptoms The aim of this study was to determine the effectiveness of pelvic floor exercise and quality of life in reducing pain in adolescents with primary dysmenorrhea.

Description:

Research; planned as randomized controlled. The research is planned to be carried out in a faculty of Nursing, which provides service with 1 department of a university with 38.482 student capacity, continuing education with 15 faculties, 1,600 academic 1.152 administrative staff in the city center of Konya.

The population of the study is all female students who have been studying since 2018-2019 academic year. The population of the study is all female students who have been studying since 2018-2019 academic year.

The sample size of the study will be composed of female students who have the complaint of dysmenorrhea as a result of the pre-test and who agree to participate in the study.

The power analysis was used to determine the number of cases that required pelvic floor exercise and control groups for the study. In the study of Gamit et al., It was accepted that the mean pain decreased from 6.10 (1 ± 35) to 4.6 with a 1.5 decrease. Considering the data losses to be experienced during the study, 30 female patients were planned to be included in each group (Potur and Kömürcü 2014).

Working Group: Before randomization, Dismenorrhea Diagnosis Form will be applied to women students who agree to participate in the study according to the sample selection criteria and general information about the study will be given and their general consent will be obtained for participation in the study. In accordance with the sample size determined by power analysis, random assignment to experimental and control groups will be made. Block randomization system will be used.

Once randomization has occurred, it is not possible to blind the participants or health professionals. However, in the analysis phase of the data, the blind of the statistician and the writing of the report will be made.

Data Collection Technique and Tools Participation Criteria Form (Dysmenorrhea Diagnostic Form), Data Collection Form, Dysmenorrhea Follow-up Form, Visual Analogue Scale (VAS), Health Related Quality of Life Questionnaire (Short Form-36) (SF-36).

Data collection forms were created by the researcher in the light of literature .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 30, 2021
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 25 Years

Eligibility

Inclusion Criteria:

• Describe dysmenorrhea pain severity as five and above on the visual comparison scale in the form of diagnosis of dysmenorrhea,

• Being single,

• Regular menstruation for the last 6 months (every 21-35 days with no intermittent bleeding),

• Body Mass Index (BMI) is between 19-29,

• 19-25 years of age

• Voluntary acceptance of participation in the study

Exclusion Criteria:

• Having systemic and chronic diseases,

• Physical disability,

• Professional athlete,

• Using hormonal contraception (such as oral contraceptives and injections) and IUD,

• Secondary dysmenorrhea pathology (ultrasound examinations will be performed by a gynecologist).

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Behavioral:
• pelvic base exercise, core exercise
Effectiveness of the pelvic base exercise on the pain and quality of life in dysmenoral youth 40 minutes exercise intervention 4 times a week for 8 weeks

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
SINEM BAGCI

Country where clinical trial is conducted

Turkey, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (pain intensity)	Patients will be asked to keep a diary with VAS to determine the severity of pain during menstruation. Patients will be asked to mark their degree of pain on a horizontal line of 100 millimeters (mm). 0: no pain, 10: maximum means more pain than can be tolerated. The point marked on the line will be measured with a ruler and recorded as the pain intensity in cm during the menstruation. Patients will be asked to mark their pain on a separate scale for each day of menstruation. Cases will mark the most severe pain during the day during menstruation on the Visual Analogue Scale (VAS) during the 3 menstrual cycles in which the study is being conducted.8 weeks of application will be done and 3 cycle will be followed	8 weeks
Secondary	Quality of Life Questionnaire(short form-36)(SF-36)	SF-36 is a 36-item self-assessment scale consisting of eight subscales. This scale is based on physical function (10 items), role restrictions (physical (4 items) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items). and general health (5 items), each subscale is scored between 0-100 and 0 0 'is the lowest and "100' is the best quality of life.; Before starting the study, the first measurement will be taken in the 2nd and 3rd menstrual cycle with an interval of 4 weeks.	8 weeks