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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06075654
Other study ID # P.T.REC/012/004091
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date October 3, 2023

Study information

Verified date October 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to investigate the difference in the severity of primary dysmenorrhea between athletic and non-athletic females.


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


Recruitment information / eligibility

Status Completed
Enrollment 628
Est. completion date October 3, 2023
Est. primary completion date September 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria: - Common inclusion criteria for athletic and non-athletic female. 1. They had a regular menstrual cycle with a menstrual cycle length of 21-30 days. 2. All females were virgins. 3. Their ages ranged from 18 to 28 years old. 4. Their BMI was ranged from 18.5 -29,9 kg/m2 5. They did not use any pharmacological therapies for controlling pain during menstruation and during the application of the study. Inclusion criteria athletic female: 1. They participated in the exercise for the last = 6 months. 2. They did exercises for = 3 days/ week. 3. They practiced (swimming, basketball, volleyball, ballet, gymnastics, judo, wrestling, karate, and boxing). Exclusion Criteria: 1. History of pelvic pathology or any gynecological disease. 2. They had a history of chronic illness (eg: diabetes). 3. Their symptoms of dysmenorrhea became worse over time

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention it is considered (Epidemiological Study)
It was a survey used Visual Analog Scale and WaLIDD scale to measure the severity of primary dysmenorrhea between both groups

Locations

Country Name City State
Egypt Khloud Ramadan Abd El- Fatah Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain Data will be collected at a single time point, which is the baseline assessment
Secondary Working ability, location, Intensity, Disability Dysmenorrhea scale. 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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