Primary DysmenorrheaNCT04451629
Effect of Exercise on Primary Dysmenorrhea
A study testing pelvıc base exercıse, core exercise in people with Primary Dysmenorrhea, run by SİNEM BAĞCI at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- pelvıc base exercıse, core exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2018to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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 .
- Conditions
- Primary Dysmenorrhea
- Being tested
- pelvıc base exercıse, core exercise
- Keywords
- Exercise, Quality of Life, Dysmenorrhea
- Medical subject headings
- Motor Activity, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvıc base exercıse, core exerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Exercises group | Experimental | intervention group çalışma grubundaki kadın öğrencilere 8 hafta süresince haftada 4 kez 40 dakika boyunca pelvik taban ve core egzersizleri uygulatılacak Receives: Behavioral: pelvıc base exercıse, core exercise |
| control group | No intervention | students will be watched without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start15 Nov 2018
- Primary completion31 May 2019
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment a experimental design with pre test and post test
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SİNEM BAĞCI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SİNEM BAĞCI, Necmettin Erbakan University
- Investigators
- Emel EGE, PROFESOR, Study director, THESIS ADVISOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451629
- Sponsor's protocol ID
- NEU
- Status last verified
- Jun 2020
- First submitted
- 14 Jan 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be planned with the conclusion of the study
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 23158705Davis 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 11358700Cakir 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 18045301De 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 26841639Dixon 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 7469530Erenel 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 17060018Kapoor 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 24656704Rosyida 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Pain and Qulity of Life on People in Primary Dysmenorrhea Complaints
- ClinicalTrials.gov ID
- NCT04451629
- Acronym / sponsor ID
- NEU
- Conditions
- Primary Dysmenorrhea
- Keywords
- Exercise, Quality of Life, Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SİNEM BAĞCIUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment a experimental design with pre test and post test
| Arm | Type | Receives |
|---|---|---|
| Exercises group | Experimental | Behavioral: pelvıc base exercıse, core exerciseintervention group çalışma grubundaki kadın öğrencilere 8 hafta süresince haftada 4 kez 40 dakika boyunca pelvik taban ve core egzersizleri uygulatılacak |
| control group | No intervention | –students will be watched without any intervention |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Describe dysmenorrhea pain severity as five and above on the visual comparison scale in the form of diagnosis of dysmenorrhea,
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pelvıc base exercıse, core exerciseEffectıveness 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 | Behavioural | Exercises group |
Primary outcome
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
1 secondary outcome
Quality of Life Questionnaire(short form-36)(SF-36)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- BackgroundAbbaspour Z, Rostami M, Najjar S. Theeffect of exercise on primary dysmenorrhea. J Res Health Sci; 2006. 6(1):26-31.
- Background: PubMed 23158705Apay 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.
- Background: PubMed 11358700Davis 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.
- Background: PubMed 18045301Cakir 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.
- Background: PubMed 26841639De 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.
- Background: PubMed 7469530Dixon 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.
- BackgroundErenel 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.
- BackgroundErkek YZ, Pasinlioğlu T. Doğum Ağrısında Kullanılan Tamamlayıcı Tedavi Yöntemleri. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 2016. 19, 1.
- BackgroundGün Ç, Demirci N, Otrar M. Dismenore Yönetiminde Tamamlayıcı Alternatif Tedavileri Kullanma Durumu. Spatula DD, 2014. 4(4), 191-197.
- Background: PubMed 17060018Doty 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.
- BackgroundKapoor 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.
- BackgroundKhare 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.
- Individual participant dataSharing planned: No. will be planned with the conclusion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emel EGE, PROFESOR study director
THESIS ADVISOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvıc base exercıse, core exercise in people with Primary Dysmenorrhea, run by SİNEM BAĞCI at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (pain intensity) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451629, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.