Primary DysmenorrheaNCT03625375
Effects of Combined Exercises on Primary Dysmenorrhea
A study testing Exercise in people with Primary Dysmenorrhea, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Dysmenorrhea is one of the most common gynecological problem in adolescents and young women. Symptoms of dysmenorrhea include pelvic / abdominal pain, back pain, headache, nausea, vomiting, diarrhea. These symptoms occur before menstrual bleeding or with bleeding and lasts in 12-74 hours. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCyprus
- Study dates
- 20 Jun 2018to Sep 2018
- 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 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The Visual Analogue Scale value is at least 5 per day when the dysmenorrhea symptoms are the most painful,
- To have the regular menstrual cycle (24-35 days),
- Being a sedentary (not participating in any regular exercise program).
Who cannot join
- Women with secondary dysmenorrhea,
- The women who gave birth or abortion,
- People with active sexual experience,
- Women who use intrauterine devices,
- Individuals with regular drug use,
- Serious psychological problems
- Acute musculoskeletal problems,
- People with neurological or cardiopulmonary disease.
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Eastern Mediterranean University
Famagusta, 99450
Cisel Demiralp, Bsc
Cisel Demiralp, Bsc, 05338412953, ciseldemir.cd@gmail.com
About this study
Dysmenorrhea is one of the most common gynecological problem in adolescents and young women. Symptoms of dysmenorrhea include pelvic / abdominal pain, back pain, headache, nausea, vomiting, diarrhea. These symptoms occur before menstrual bleeding or with bleeding and lasts in 12-74 hours. The objective of this study to investigate the effects of combined exercises on dysmenorrhea symptoms. Exercise protocol aerobic, stretching, kegels, pelvic motions and relaxation exercises.
Read the detailed description
Women with a positive primary dysmenorrhoea symptom between 18 and 30 years of age living in the Turkish Republic of Northern Cyprus will be included in the study. According to the result of the power analysis, 14 subjet for control and 14subjet intervention group were decided.
The eligibility criteria for this study are:
- The Visual Analogue Scale value is at least 5 per day when the dysmenorrhea symptoms are the most painful,
- To have the regular menstrual cycle (24-35 days),
- To be sedentary
The exclusion criteria for this study are:
- Women with secondary dysmenorrhea,
- The women who gave birth or abortion,
- People with active sexual experience,
- Women who use intrauterine devices,
- Individuals with regular drug use,
- Serious psychological problems
- Acute musculoskeletal problems,
- People with neurological or cardiopulmonary disease
This research will consist of exercise and control groups. An exercise protocol consisting of a combination of various exercises will be applied to the exercise group and no exercises will be done for the control group. women in the exercise group will perform two menstrual cycles, three times a week in the presence of a physiotherapist.
Assessments will be made on the day that the symptoms are seen to be the most severe in order to determine the symptoms of the women in both groups. After baseline assements exercises will start at 3rd day of cycle. Assesments will repeat at second and third menstrual bleedings.
Visual Analogue Scale, Menstrual symptom questionnarie and Pittsburgh Sleep Quality Index will be use.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Exercise
- Keywords
- exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Intervention consist of aerobic, stretchig, pelvic motions, kegels and relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Individuals will perform exercises 3 times a week. Receives: Other: Exercise |
| Control Group | No intervention | Individuals will not perform exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain changes from baseline to 8 weeks
to asses pain level with Visual Analogue Scale. 0 means no pain. Higher points means higher pain.
Measured: To asses pain level changes in this study assement make at baseline and repeat after 1 and 2 months
Secondary outcomes (2)
menstrual symptoms changes from baseline to 8 weeks
to asses menstrual symptoms with menstrual symptoms questionnarie. we will use total point as a data. points are vary between 0 and 110. Higher points means having worse menstrual symptpms.
Measured: At baseline, after 4 weeks from baseline and 8 weeks after baseline
sleep quality changes from baseline to 8 weeks
to asses sleep quality with pittsburgh sleep quality index. We will use total point as data. lowest grade is 0 and 21 is higher point. 0-5 means good sleep, after 10 point it means worse sleep quality
Measured: At baseline of the study, after 4 weeks from baseline and 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start20 Jun 2018
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berkiye Kırmızıgil, Study director, Eastern Meditteranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625375
- Sponsor's protocol ID
- Dysmenorrhea
- Status last verified
- Sep 2018
- First submitted
- 4 Jun 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.
PubMed 32415471
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Exercises on Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03625375
- Acronym / sponsor ID
- Dysmenorrhea
- Conditions
- Primary Dysmenorrhea
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 10 Aug 2018 (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.
Dysmenorrhea is one of the most common gynecological problem in adolescents and young women. Symptoms of dysmenorrhea include pelvic / abdominal pain, back pain, headache, nausea, vomiting, diarrhea. These symptoms occur before menstrual bleeding or with bleeding and lasts in 12-74 hours. The objective of this study to investigate the effects of combined exercises on dysmenorrhea symptoms. Exercise protocol aerobic, stretching, kegels, pelvic motions and relaxation exercises.
Detailed description
Women with a positive primary dysmenorrhoea symptom between 18 and 30 years of age living in the Turkish Republic of Northern Cyprus will be included in the study. According to the result of the power analysis, 14 subjet for control and 14subjet intervention group were decided.
The eligibility criteria for this study are:
- The Visual Analogue Scale value is at least 5 per day when the dysmenorrhea symptoms are the most painful,
- To have the regular menstrual cycle (24-35 days),
- To be sedentary
The exclusion criteria for this study are:
- Women with secondary dysmenorrhea,
- The women who gave birth or abortion,
- People with active sexual experience,
- Women who use intrauterine devices,
- Individuals with regular drug use,
- Serious psychological problems
- Acute musculoskeletal problems,
- People with neurological or cardiopulmonary disease
This research will consist of exercise and control groups. An exercise protocol consisting of a combination of various exercises will be applied to the exercise group and no exercises will be done for the control group. women in the exercise group will perform two menstrual cycles, three times a week in the presence of a physiotherapist.
Assessments will be made on the day that the symptoms are seen to be the most severe in order to determine the symptoms of the women in both groups. After baseline assements exercises will start at 3rd day of cycle. Assesments will repeat at second and third menstrual bleedings.
Visual Analogue Scale, Menstrual symptom questionnarie and Pittsburgh Sleep Quality Index will be use.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: ExerciseIndividuals will perform exercises 3 times a week. |
| Control Group | No intervention | –Individuals will not perform exercises |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The Visual Analogue Scale value is at least 5 per day when the dysmenorrhea symptoms are the most painful,
- To have the regular menstrual cycle (24-35 days),
- Being a sedentary (not participating in any regular exercise program).
Key exclusion criteria (8 listed)
- Women with secondary dysmenorrhea,
- The women who gave birth or abortion,
- People with active sexual experience,
- Women who use intrauterine devices,
- Individuals with regular drug use,
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 |
|---|---|---|
| ExerciseIntervention consist of aerobic, stretchig, pelvic motions, kegels and relaxation exercises | Other | Treatment Group |
Primary outcome
pain changes from baseline to 8 weeks
Time frame: To asses pain level changes in this study assement make at baseline and repeat after 1 and 2 months
to asses pain level with Visual Analogue Scale. 0 means no pain. Higher points means higher pain.
2 secondary outcomes
menstrual symptoms changes from baseline to 8 weeks
Time frame: At baseline, after 4 weeks from baseline and 8 weeks after baseline
sleep quality changes from baseline to 8 weeks
Time frame: At baseline of the study, after 4 weeks from baseline and 8 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Derived from this study: PubMed 32415471Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Dysmenorrhea
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Recruiting
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Dysmenorrhea, Primary Dysmenorrhea
Not yet recruiting
The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
Dysmenorrhea Primary
Not yet recruiting
Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain
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.
Berkiye Kırmızıgil study director
Eastern Meditteranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Primary Dysmenorrhea, run by Eastern Mediterranean University at 1 site in Cyprus.
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 3 inclusion and 8 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 27 Sep 2018. 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 Cyprus. 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?
Contact Cisel Demiralp (095338412953, ptciseldemiralp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain changes from baseline to 8 weeks (time frame: To asses pain level changes in this study assement make at baseline and repeat after 1 and 2 months). 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 NCT03625375, which also lists 1 linked publication.
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 27 Sep 2018.