CClinicalTrials.gg
Status unknownNCT04451629Updated Jun 30, 2020

Effect of Exercise on Primary Dysmenorrhea

An interventional study of pelvıc base exercıse, core exercise in Primary Dysmenorrhea, sponsored by SİNEM BAĞCI. Status unknown at 1 site in Turkey. Open to female participants aged 19 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by SİNEM BAĞCI · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2018, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 25 Years
Sex
Female
01

Study 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.

Read the 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 .

02

Conditions studied

  • Primary Dysmenorrhea

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Keywords

  • Exercise
  • Quality of Life
  • Dysmenorrhea
03

In context

Dysmenorrhea

398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 333 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

This is the only study on the registry with SİNEM BAĞCI as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Exercises group

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

    Behavioral: pelvıc base exercıse, core exercise

  • No intervention
    control group

    students will be watched without any intervention

Interventions

  • Behavioralpelvıc base exercıse, core exercise

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Necmettin Erbakan University
    Konya, 42100, Turkey
08

References and documents

Publications

  • Abbaspour Z, Rostami M, Najjar S. Theeffect of exercise on primary dysmenorrhea. J Res Health Sci; 2006. 6(1):26-31.
  • 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. PubMed 23158705 ↗
  • 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. PubMed 11358700 ↗
  • 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. PubMed 18045301 ↗
  • 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. PubMed 26841639 ↗
  • 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. PubMed 7469530 ↗
  • 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. PubMed 17060018 ↗
  • 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. PubMed 24656704 ↗
  • 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. PubMed 20493741 ↗
  • 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. PubMed 22901294 ↗
  • 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. PubMed 24856936 ↗
  • 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. PubMed 15243011 ↗
  • 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. PubMed 15575029 ↗
  • 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. PubMed 24230963 ↗
  • 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. PubMed 24631318 ↗
  • 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. PubMed 28042403 ↗
  • 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. PubMed 9817107 ↗

Individual participant data

Plan to share: No — will be planned with the conclusion of the study

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04451629
Lead sponsor
SİNEM BAĞCI
Responsible party
SİNEM BAĞCI (Principal Investigator, Necmettin Erbakan University) — Sponsor-investigator
First posted
Jun 30, 2020
Start date
Nov 15, 2018
Primary completion
May 31, 2019
Completion
Jan 30, 2021 (estimated)
Last update
Jun 30, 2020

Study contacts

Emel EGE, PROFESOR
study director · THESIS ADVISOR

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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