Primary DysmenorrheaNCT06075654
Primary Dysmenorrhea Severity in Athletic vs. Non-Athletic Females
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to investigate the difference in the severity of primary dysmenorrhea between athletic and non-athletic females. Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- How many people
- 628 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 3 Oct 2023
- Phase
- Observational
- 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 28 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
The aim of the study is to investigate the difference in the severity of primary dysmenorrhea between athletic and non-athletic females.
Read the 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
- Conditions
- Primary Dysmenorrhea
- Being tested
- no intervention it is considered (Epidemiological Study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention it is considered (Epidemiological Study)Other
It was a survey used Visual Analog Scale and WaLIDD scale to measure the severity of primary dysmenorrhea between both groups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: no intervention it is considered (Epidemiological Study) | |
| Non-Athletic Group | Non-athletic females complaining form primary dysmenorrhea who are have not participated in any physical activity before Receives: Other: no intervention it is considered (Epidemiological Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Data will be collected at a single time point, which is the baseline assessment
Secondary outcomes (1)
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.
Measured: Data will be collected at a single time point, which is the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Mar 2023
- Primary completion21 Sep 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khloud ramadan Abd El- fatah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075654
- Sponsor's protocol ID
- P.T.REC/012/004091
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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.
- ClinicalTrials.gov ID
- NCT06075654
- Acronym / sponsor ID
- P.T.REC/012/004091
- Conditions
- Primary Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 10 Oct 2023 (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.
The aim of the study is to investigate the difference in the severity of primary dysmenorrhea between athletic and non-athletic females.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Athletic Group | – | Other: no intervention it is considered (Epidemiological Study)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. |
| Non-Athletic Group | – | Other: no intervention it is considered (Epidemiological Study)Non-athletic females complaining form primary dysmenorrhea who are have not participated in any physical activity before |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (9 listed)
- Common inclusion criteria for athletic and non-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).
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| 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 | Other | Athletic Group, Non-Athletic Group |
Primary outcome
Visual Analogue Scale
Time frame: Data will be collected at a single time point, which is the baseline assessment
The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain
1 secondary outcome
Working ability, location, Intensity, Disability Dysmenorrhea scale.
Time frame: Data will be collected at a single time point, which is the baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 3 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: finished, as of the sponsor's last update on 16 Oct 2023. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Data will be collected at a single time point, which is the baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2023.