- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04451629
Effect of Exercise on Primary Dysmenorrhea
Effect of Exercise on Pain and Qulity of Life on People in Primary Dysmenorrhea Complaints
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Konya, Turkey, 42100
- Necmettin Erbakan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercises group
intervention group çalışma grubundaki kadın öğrencilere 8 hafta süresince haftada 4 kez 40 dakika boyunca pelvik taban ve core egzersizleri uygulatılacak
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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
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No Intervention: control group
students will be watched without any intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (pain intensity)
Time Frame: 8 weeks
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Questionnaire(short form-36)(SF-36)
Time Frame: 8 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Emel EGE, PROFESOR, thesis advisor
Publications and helpful links
General Publications
- Davis AR, Westhoff CL. Primary dysmenorrhea in adolescent girls and treatment with oral contraceptives. J Pediatr Adolesc Gynecol. 2001 Feb;14(1):3-8. doi: 10.1016/s1083-3188(00)00076-0.
- Kannan P, Claydon LS. Some physiotherapy treatments may relieve menstrual pain in women with primary dysmenorrhea: a systematic review. J Physiother. 2014 Mar;60(1):13-21. doi: 10.1016/j.jphys.2013.12.003. Epub 2014 Apr 24.
- De Sanctis V, Soliman A, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Rigon F, Perissinotto E. Primary Dysmenorrhea in Adolescents: Prevalence, Impact and Recent Knowledge. Pediatr Endocrinol Rev. 2015 Dec;13(2):512-20.
- Apay SE, Arslan S, Akpinar RB, Celebioglu A. Effect of aromatherapy massage on dysmenorrhea in Turkish students. Pain Manag Nurs. 2012 Dec;13(4):236-40. doi: 10.1016/j.pmn.2010.04.002. Epub 2010 Sep 15.
- Abbaspour Z, Rostami M, Najjar S. Theeffect of exercise on primary dysmenorrhea. J Res Health Sci; 2006. 6(1):26-31.
- Cakir M, Mungan I, Karakas T, Girisken I, Okten A. Menstrual pattern and common menstrual disorders among university students in Turkey. Pediatr Int. 2007 Dec;49(6):938-42. doi: 10.1111/j.1442-200X.2007.02489.x.
- Dixon JS, Bird HA. Reproducibility along a 10 cm vertical visual analogue scale. Ann Rheum Dis. 1981 Feb;40(1):87-9. doi: 10.1136/ard.40.1.87.
- Erenel ŞA, Şentürk A. Sağlık Meslek Lisesi Öğrencilerinin Dismenore Yaşama Durumları ve Dismenore ile Baş Etmeye Yönelik Uygulamaları. Hacettepe Hemşirelik Yüksekokulu Dergisi. 2007. 2, 48-60.
- Erkek YZ, Pasinlioğlu T. Doğum Ağrısında Kullanılan Tamamlayıcı Tedavi Yöntemleri. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 2016. 19, 1.
- Gün Ç, Demirci N, Otrar M. Dismenore Yönetiminde Tamamlayıcı Alternatif Tedavileri Kullanma Durumu. Spatula DD, 2014. 4(4), 191-197.
- Doty E, Attaran M. Managing primary dysmenorrhea. J Pediatr Adolesc Gynecol. 2006 Oct;19(5):341-4. doi: 10.1016/j.jpag.2006.06.005. No abstract available.
- Kapoor J, Kaur N, Sharma M, Kaur S. A study to assess the effectiveness of pelvic rocking exercises on dysmenorrhea among adolescent girls. International Journal of Applied Research. 2017. 3(3): 431-434.
- Khare D, Jain P. Effect of Different Exercise Techniques on Primary Dysmenorrhoea among Higher Secondary School Girls. International Journal of Science and Research (IJSR). Index Copernicus Value. 2015. 78-96.
- Mazza D. Primary dysmenorrhea. Women's Health Medicine. 2006. 3: 207-210.
- Potur DC, Komurcu N. The effects of local low-dose heat application on dysmenorrhea. J Pediatr Adolesc Gynecol. 2014 Aug;27(4):216-21. doi: 10.1016/j.jpag.2013.11.003. Epub 2014 Mar 19.
- Rosyida DAC, Suwandono A, Ariyanti I, Suhartono, Mashoedi ID, Fatmasari D. Comparison of Effects of Abdominal Stretching Exercise and Cold CompressTherapy on Menstrual PainIntensity in Teenage Girls. Belitung Nursing Journal. 2017. 3(3):221-228.
- Sevil Ü. Adölesan Dönemi. İçinden: Kadın Sağlığı. Eds: Ahsen Şirin, Oya Kavlak. Bedray Basın Yayıncılık LtdŞti.,İstanbul.2008.s.57-91.
- Shahr-Jerdy S, Hosseini RS, Gh ME. The effect of stretching exercises on primary dysmenorrhea in adolescent girls. Biomedical Human Kinetics.2012; 4 : 127-132 .10.2478 / v10101-012-0024-y.
- Sutar A, Paldhikar S, Shikalgar N, Ghodey S. Effect of aerobic exercises on primary dysmenorrhoea in college students. IOSR Journal of Nursing and Health Science (IOSR -JNHS) ISSN: 2320-1959.p-Volume 5, Issue 5 Ver. V (Sep.Oct. 2016), PP 20-24.
- Taşkın L. (Ed). Doğum ve Kadın Sağlığı Hemşireliği. Üreme siklusus anomalileri. İçinde: X. baskı. Ankara: Sistem Ofset Matbaacılık; 2016:ss 733-736.
- Eryilmaz G, Ozdemir F, Pasinlioglu T. Dysmenorrhea prevalence among adolescents in eastern Turkey: its effects on school performance and relationships with family and friends. J Pediatr Adolesc Gynecol. 2010 Oct;23(5):267-72. doi: 10.1016/j.jpag.2010.02.009. Epub 2010 May 21.
- Guvenc G, Kilic A, Akyuz A, Ustunsoz A. Premenstrual syndrome and attitudes toward menstruation in a sample of nursing students. J Psychosom Obstet Gynaecol. 2012 Sep;33(3):106-11. doi: 10.3109/0167482X.2012.685906.
- Marsden JS, Strickland CD, Clements TL. Guaifenesin as a treatment for primary dysmenorrhea. J Am Board Fam Pract. 2004 Jul-Aug;17(4):240-6. doi: 10.3122/jabfm.17.4.240.
- Nasir L, Bope ET. Management of pelvic pain from dysmenorrhea or endometriosis. J Am Board Fam Pract. 2004 Nov-Dec;17 Suppl:S43-7. doi: 10.3122/jabfm.17.suppl_1.s43.
- Potur DC, Bilgin NC, Komurcu N. Prevalence of dysmenorrhea in university students in Turkey: effect on daily activities and evaluation of different pain management methods. Pain Manag Nurs. 2014 Dec;15(4):768-77. doi: 10.1016/j.pmn.2013.07.012. Epub 2013 Nov 11.
- Seven M, Guvenc G, Akyuz A, Eski F. Evaluating dysmenorrhea in a sample of Turkish nursing students. Pain Manag Nurs. 2014 Sep;15(3):664-71. doi: 10.1016/j.pmn.2013.07.006. Epub 2014 Mar 14.
- Motahari-Tabari N, Shirvani MA, Alipour A. Comparison of the Effect of Stretching Exercises and Mefenamic Acid on the Reduction of Pain and Menstruation Characteristics in Primary Dysmenorrhea: A Randomized Clinical Trial. Oman Med J. 2017 Jan;32(1):47-53. doi: 10.5001/omj.2017.09.
- Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998 Nov;51(11):903-12. doi: 10.1016/s0895-4356(98)00081-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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