Lifestyle Influence on Primary Dysmenorrhea

October 5, 2020 updated by: Naser Al-Husban, University of Jordan

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

Study Overview

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Al-Husban Naser, A. Professor
  • Phone Number: +962772086080
  • Email: Husban48@yahoo.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

Females Healthy Living in Jordan

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the prevalence of primary dysmenorrhea in Jordanian females
Time Frame: 6 months
Assess the prevalence of primary dysmenorrhea in Jordanian females aged 18-25
6 months
the severity of primary dysmenorrhea
Time Frame: 6 months
Assess the severity of primary dysmenorrhea in Jordanian females aged 18-25
6 months
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
national recommendations to the Jordanian community regarding primary dysmenorrhea and ways to deal with this common problem.
Time Frame: 6 months
Come up with national recommendations to the Jordanian community regarding primary dysmenorrhea and ways to deal with this common problem.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Al-Husban Naser, A. Professor, The University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2020

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

April 30, 2021

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (ACTUAL)

October 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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