- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06075654
Primary Dysmenorrhea Severity in Athletic vs. Non-Athletic Females
"Comparison of the Severity of Primary Dysmenorrhea Between Athletic and Non-Athletic Females: A Cross-Sectional Study" Comparison of the Severity of Primary Dysmenorrhea Between Athletic and Non-Athletic Females: A Cross-Sectional Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary dysmenorrhea is defined as colic pain in the lower abdomen which starts with the onset of menstruation. It is one of the most common gynecological disorders, an important cause of morbidity, and the most common cause of pelvic pain in menstruating girls and women it affects women in any age group. The prevalence varies widely, ranging from 17% to as high as 91%. Between 16% to 29% of women with dysmenorrhea have significant impairment in quality of life and the women's well-being. The rate of absenteeism from school, work, or other activities represents up to 15% of women with dysmenorrhea, dysmenorrhea is considered a source of considerable economic losses due to the costs of medications, medical care, and decreased productivity. Yoga, pilates, stretching, and other types of exercises have a noticeable effect on decreasing pain, and improving general health, and quality of sleep with different health conditions including primary dysmenorrhea. In addition, exercise and physical activity are used widely and proven to not only decrease pain but also improve quality of life, decrease stress, improve mental health, and in management of depression and stress.
For dysmenorrhea the mechanism that explained the effect of exercises on primary dysmenorrhea has been classified according to the intensity of the exercises; moderate -high-intensity exercise was believed to increase the anti-inflammatory cytokines, decrease the overall amount of prostaglandins released because of the decrease of the overall amount of menstrual flow. Low-intensity exercise reduces cortisol levels and prostaglandin synthesis
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Khloud Ramadan Abd El- Fatah
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The athletic group will be selected from different clubs in Egypt for example; Benha, Tanta, Maadi, and Wadi-Degla clubs.
Non- athletic will be selected from females and their their accompanying individuals
Description
Inclusion Criteria:
Common inclusion criteria for athletic and non-athletic female.
- They had a regular menstrual cycle with a menstrual cycle length of 21-30 days.
- All females were virgins.
- Their ages ranged from 18 to 28 years old.
- Their BMI was ranged from 18.5 -29,9 kg/m2
- They did not use any pharmacological therapies for controlling pain during menstruation and during the application of the study.
Inclusion criteria athletic female:
- They participated in the exercise for the last ≥ 6 months.
- They did exercises for ≥ 3 days/ week.
- They practiced (swimming, basketball, volleyball, ballet, gymnastics, judo, wrestling, karate, and boxing).
Exclusion Criteria:
- History of pelvic pathology or any gynecological disease.
- They had a history of chronic illness (eg: diabetes).
- Their symptoms of dysmenorrhea became worse over time
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Athletic Group
athletic females complaining of primary dysmenorrhea, they participated in the exercise for the last ≥ 6 months, did exercises for ≥ 3 days/ week, and practiced (swimming, basketball, volleyball, gymnastics, judo, wrestling, karate, and boxing.
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It was a survey used Visual Analog Scale and WaLIDD scale to measure the severity of primary dysmenorrhea between both groups
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Non-Athletic Group
Non-athletic females complaining form primary dysmenorrhea who are have not participated in any physical activity before
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It was a survey used Visual Analog Scale and WaLIDD scale to measure the severity of primary dysmenorrhea between both groups
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Scale
Time Frame: Data will be collected at a single time point, which is the baseline assessment
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The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain
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Data will be collected at a single time point, which is the baseline assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Working ability, location, Intensity, Disability Dysmenorrhea scale.
Time Frame: Data will be collected at a single time point, which is the baseline assessment
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measuring a combination of manifestations: subjective (intensity /Wong-Baker, work ability) and objective (days of pain, location). In which each aspect of scale are rated from 0 to 3. 0 indicate no dysmenorrhea, 1-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 sever dysmenorrhea. |
Data will be collected at a single time point, which is the baseline assessment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004091
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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