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Effect of Exercise on Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pelvıc base exercıse, core exercise
Sponsored by
SİNEM BAĞCI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Dysmenorrhea focused on measuring Exercise, Quality of Life, Dysmenorrhea

Eligibility Criteria

19 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Necmettin Erbakan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercises group

control group

Arm Description

intervention group çalışma grubundaki kadın öğrencilere 8 hafta süresince haftada 4 kez 40 dakika boyunca pelvik taban ve core egzersizleri uygulatılacak

students will be watched without any intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 14, 2020
Last Updated
June 25, 2020
Sponsor
SİNEM BAĞCI
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1. Study Identification

Unique Protocol Identification Number
NCT04451629
Brief Title
Effect of Exercise on Primary Dysmenorrhea
Official Title
Effect of Exercise on Pain and Qulity of Life on People in Primary Dysmenorrhea Complaints
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
January 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
SİNEM BAĞCI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Exercise, Quality of Life, Dysmenorrhea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment a experimental design with pre test and post test
Masking
Outcomes Assessor
Masking Description
Parallel Assignment a experimental design with pre test and post test
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercises group
Arm Type
Experimental
Arm Description
intervention group çalışma grubundaki kadın öğrencilere 8 hafta süresince haftada 4 kez 40 dakika boyunca pelvik taban ve core egzersizleri uygulatılacak
Arm Title
control group
Arm Type
No Intervention
Arm Description
students will be watched without any intervention
Intervention Type
Behavioral
Intervention Name(s)
pelvıc base exercıse, core exercise
Intervention Description
Effectıveness of the pelvıc base exercıse on the paın and qualıty of lıfe ın dysmenoral youth 40 minutes exercise intervention 4 times a week for 8 weeks
Primary Outcome Measure Information:
Title
Visual Analogue Scale (pain intensity)
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire(short form-36)(SF-36)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Dysmenore as seen ın adolescent women face to face with the adolescent students themselves
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emel EGE, PROFESOR
Organizational Affiliation
THESIS ADVISOR
Official's Role
Study Director
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
ZIP/Postal Code
42100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
will be planned with the conclusion of the study
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Effect of Exercise on Primary Dysmenorrhea

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