Menstruation DisturbancesNCT04583943
Lifestyle Influence on Primary Dysmenorrhea
An observational study of Menstruation Disturbances and Dysmenorrhea Primary, run by University of Jordan.
Trial summary
There is a correlation between the effect of lifestyle and prevalence and severity of primary dysmenorrhea. We will collect data through an online questionnaire. This study is an attempt to elaborate on and clarify the prevalence and severity of primary dysmenorrhea in Jordan. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation Disturbances, Dysmenorrhea Primary
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 30 Apr 2021
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will be conducted in all Jordanian governorates (Amman, Irbid, Madaba, Zarqa, Balqa, Mafraq, Ajloun, Jerash, Karak, Tafileh, Maan, and Aqaba) The inclusion criteria for this study include females between the age of 18 and 25, living in Jordan only, medically free. We will not regard ethnicity and religion as part of our inclusion criteria since they are out of the scope of our research and can be specifically studied in future researches
Who may be able to join
- Females Healthy Living in Jordan
Who cannot join
- Males females beyond age group 18-25 women not living in Jordan Females with chronic medical or gynecological illness Females not able to provide consent for the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Influence of Lifestyle Variables on Primary Dysmenorrhea; Cross-sectional Study
There is a correlation between the effect of lifestyle and prevalence and severity of primary dysmenorrhea. We will collect data through an online questionnaire. This study is an attempt to elaborate on and clarify the prevalence and severity of primary dysmenorrhea in Jordan. This study has already been applied to other target populations therefore the purpose of this study is to establish solid numbers of dysmenorrhea prevalence in Jordan among the age group 18-25 and to exhibit a clear correlation between the lifestyle habits adopted by individuals and the intensity of dysmenorrhea present. The lifestyle factors chosen include body mass index (BMI), smoking, early menarche, prolonged menstrual flow and psychological disturbances. The significance of forming this relationship is to help raise awareness among the young generation of Jordanian women to improve on their adopted lifestyle habits in order to eventually lead to lower numbers of morbidity associated with dysmenorrhea
Read the detailed description
Primary cross-sectional study. The study will be conducted in all Jordanian governorates (Amman, Irbid, Madaba, Zarqa, Balqa, Mafraq, Ajloun, Jerash, Karak, Tafileh, Maan, and Aqaba) The inclusion criteria for this study include females between the age of 18 and 25, living in Jordan only, medically free. We will not regard ethnicity and religion as part of our inclusion criteria since they are out of the scope of our research and can be specifically studied in future researches. The exclusion criteria will be; males, females beyond the age limit which is (18-25), women not living In Jordan, women having any chronic illnesses or gynecological illnesses. Moreover, participants that were unable to provide consent will be excluded from the study. The sampling technique will be simple random sampling by filling the structured self-reported online questionnaire.
A Structured self-report questionnaire which we had the approval to take it, edit it and translate it to Arabic from a research conducted in Spain(1) .It's the main tool used in this research, there will be no interviews or direct contact with the participants.
Links to the questionnaire:
Pdf version: https://drive.google.com/file/d/1K7KRLsdRbCRfdklS0wwjQv-A-Yi8le4z/view?usp=sharing Google form: https://forms.gle/8juxuMc8y3BeX9io9 Word document: https://drive.google.com/file/d/168oryAAXa1S1zvz-7KYK0p2sOob2jQxJ/view?usp=sharing The questionnaire will be sent online by using different social media panels and emails, it will be also printed out and distributed in different areas, including the university of Jordan by our team of 5th year medical students.
After data collection, data will be checked and entered. It will be analyzed using the statistical software package for the social sciences (SPSS).
We will ensure participant's privacy by not asking about their names, phone number or their address. The questionnaire will be totally anonymous. Any participant has the right to withdraw from the questionnaire at any time without repercussions.
- Conditions
- Menstruation Disturbances, Dysmenorrhea Primary
- Keywords
- Dysemnorrhea, Primary, Life style, variables
- Medical subject headings
- Menstruation Disturbances
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of primary dysmenorrhea in Jordanian females
Assess the prevalence of primary dysmenorrhea in Jordanian females aged 18-25
Measured: 6 months
the severity of primary dysmenorrhea
Assess the severity of primary dysmenorrhea in Jordanian females aged 18-25
Measured: 6 months
the effect of lifestyle on the prevalence and severity of primary dysmenorrhea in
Assess the effect of lifestyle on the prevalence and severity of primary dysmenorrhea in Jordanian females aged 18-25
Measured: 6 months
Secondary outcomes (1)
national recommendations to the Jordanian community regarding primary dysmenorrhea and ways to deal with this common problem.
Come up with national recommendations to the Jordanian community regarding primary dysmenorrhea and ways to deal with this common problem.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (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 Menstruation DisturbancesStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naser Al-Husban, Jordan University Hospital
- Investigators
- Al-Husban Naser, A. Professor, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583943
- Sponsor's protocol ID
- Questionnaire
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Husban N, Odeh O, Dabit T, Masadeh A. The Influence of Lifestyle Variables on Primary Dysmenorrhea: A Cross-Sectional Study. Int J Womens Health. 2022 Apr 13;14:545-553. doi: 10.2147/IJWH.S338651. eCollection 2022.
PubMed 35444471
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Lifestyle Variables on Primary Dysmenorrhea; Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04583943
- Acronym / sponsor ID
- Questionnaire
- Conditions
- Menstruation Disturbances, Dysmenorrhea Primary
- Keywords
- Dysemnorrhea, Primary, Life style, variables
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 12 Oct 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.
There is a correlation between the effect of lifestyle and prevalence and severity of primary dysmenorrhea. We will collect data through an online questionnaire. This study is an attempt to elaborate on and clarify the prevalence and severity of primary dysmenorrhea in Jordan. This study has already been applied to other target populations therefore the purpose of this study is to establish solid numbers of dysmenorrhea prevalence in Jordan among the age group 18-25 and to exhibit a clear correlation between the lifestyle habits adopted by individuals and the intensity of dysmenorrhea present. The lifestyle factors chosen include body mass index (BMI), smoking, early menarche, prolonged menstrual flow and psychological disturbances. The significance of forming this relationship is to help raise awareness among the young generation of Jordanian women to improve on their adopted lifestyle habits in order to eventually lead to lower numbers of morbidity associated with dysmenorrhea
Detailed description
Primary cross-sectional study. The study will be conducted in all Jordanian governorates (Amman, Irbid, Madaba, Zarqa, Balqa, Mafraq, Ajloun, Jerash, Karak, Tafileh, Maan, and Aqaba) The inclusion criteria for this study include females between the age of 18 and 25, living in Jordan only, medically free. We will not regard ethnicity and religion as part of our inclusion criteria since they are out of the scope of our research and can be specifically studied in future researches. The exclusion criteria will be; males, females beyond the age limit which is (18-25), women not living In Jordan, women having any chronic illnesses or gynecological illnesses. Moreover, participants that were unable to provide consent will be excluded from the study. The sampling technique will be simple random sampling by filling the structured self-reported online questionnaire.
A Structured self-report questionnaire which we had the approval to take it, edit it and translate it to Arabic from a research conducted in Spain(1) .It's the main tool used in this research, there will be no interviews or direct contact with the participants.
Links to the questionnaire:
Pdf version: https://drive.google.com/file/d/1K7KRLsdRbCRfdklS0wwjQv-A-Yi8le4z/view?usp=sharing Google form: https://forms.gle/8juxuMc8y3BeX9io9 Word document: https://drive.google.com/file/d/168oryAAXa1S1zvz-7KYK0p2sOob2jQxJ/view?usp=sharing The questionnaire will be sent online by using different social media panels and emails, it will be also printed out and distributed in different areas, including the university of Jordan by our team of 5th year medical students.
After data collection, data will be checked and entered. It will be analyzed using the statistical software package for the social sciences (SPSS).
We will ensure participant's privacy by not asking about their names, phone number or their address. The questionnaire will be totally anonymous. Any participant has the right to withdraw from the questionnaire at any time without repercussions.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be conducted in all Jordanian governorates (Amman, Irbid, Madaba, Zarqa, Balqa, Mafraq, Ajloun, Jerash, Karak, Tafileh, Maan, and Aqaba) The inclusion criteria for this study include females between the age of 18 and 25, living in Jordan only, medically free. We will not regard ethnicity and religion as part of our inclusion criteria since they are out of the scope of our research and can be specifically studied in future researches
Key inclusion criteria (1 listed)
- Females Healthy Living in Jordan
Key exclusion criteria (1 listed)
- Males females beyond age group 18-25 women not living in Jordan Females with chronic medical or gynecological illness Females not able to provide consent for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the prevalence of primary dysmenorrhea in Jordanian females
Time frame: 6 months
Assess the prevalence of primary dysmenorrhea in Jordanian females aged 18-25
the severity of primary dysmenorrhea
Time frame: 6 months
Assess the severity of primary dysmenorrhea in Jordanian females aged 18-25
the effect of lifestyle on the prevalence and severity of primary dysmenorrhea in
Time frame: 6 months
Assess the effect of lifestyle on the prevalence and severity of primary dysmenorrhea in Jordanian females aged 18-25
1 secondary outcome
national recommendations to the Jordanian community regarding primary dysmenorrhea and ways to deal with this common problem.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Derived from this study: PubMed 35444471Al-Husban N, Odeh O, Dabit T, Masadeh A. The Influence of Lifestyle Variables on Primary Dysmenorrhea: A Cross-Sectional Study. Int J Womens Health. 2022 Apr 13;14:545-553. doi: 10.2147/IJWH.S338651. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Al-Husban Naser, A. Professor principal investigator
University of Jordan
Questions about this trial
What is this clinical trial studying?
An observational study of Menstruation Disturbances and Dysmenorrhea Primary, run by University of Jordan.
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 1 inclusion and 1 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 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Al-Husban Naser, A. Professor (+962772086080, Husban48@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of primary dysmenorrhea in Jordanian females (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT04583943, 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 12 Oct 2020.