Premenstrual Syndrome and Physical Activity Self-Worth

March 22, 2023 updated by: Asli Celik, Nigde Omer Halisdemir University

Comparison of Physical Activity Self Worth of Women With and Without Premenstrual Syndrome

Premenstrual syndrome (PMS) negatively affects the quality of life of millions of women. PMS is a common cyclic disorder characterized by somatic, cognitive, emotional and behavioral symptoms that usually occurs in young and middle-aged women, lasts during the luteal phase of the menstrual cycle and ends with the onset of menstruation.Studies have shown that women with high PMS symptoms are more inactive. Physical activity participation in women affects a wide spectrum of self-perceptions, including knowledge, social, and emotional self-perceptions. By determining which physical, emotional, social and academic/knowledge areas are affected by women, increasing their participation in physical activity can be achieved. The subject of the study is to determine the symptom severity of women with and without premenstrual syndrome and to examine how premenstrual syndrome affects physical activity self-worth.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Premenstrual syndrome (PMS) negatively affects the quality of life of millions of women. PMS is a common cyclic disorder characterized by somatic, cognitive, emotional and behavioral symptoms that usually occurs in young and middle-aged women, lasts during the luteal phase of the menstrual cycle and ends with the onset of menstruation.Studies have shown that women with high PMS symptoms are more inactive. Physical activity participation in women affects a wide spectrum of self-perceptions, including knowledge, social, and emotional self-perceptions. By determining which physical, emotional, social and academic/knowledge areas are affected by women, increasing their participation in physical activity can be achieved. The subject of the study is to determine the symptom severity of women with and without premenstrual syndrome and to examine how premenstrual syndrome affects physical activity self-worth.

A total of 296 women age of 18-35 participate in the research. Participants were divide into two groups with and without premenstrual syndrome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Niğde, Turkey, 51200
        • Nigde Omer Halisdemir University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Premenstrual syndrome (PMS) negatively affects the quality of life of millions of women. PMS is a common cyclic disorder characterized by somatic, cognitive, emotional and behavioral symptoms that usually occurs in young and middle-aged women, lasts during the luteal phase of the menstrual cycle and ends with the onset of menstruation.

Description

Inclusion Criteria:

  • Volunteer to participate in the study
  • Being 18-35 years old
  • Being women
  • To be menstruating

Exclusion Criteria:

  • Evaluation form missing
  • Not menstruating for 12 months or more
  • Having any psychological diagnosis
  • Being pregnant

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1 and Group 2
Women With and Without Premenstrual Syndrome
Other: Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data
Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Descriptive Data
Time Frame: Baseline
In the general evaluation form, data such as age, gender, weight, height, age at menarche, menstruation interval, menstrual pattern, presence of gynecological problems, presence of dysmenorrhea, pain level, exercise status, presence of chronic disease will be recorded.
Baseline
Premenstrual Syndrome Scale
Time Frame: Baseline
The Premenstrual Syndrome Scale (PMSS) was developed by Gençdoğan in 2006, based on DSM III and DSM-IV, and its validity and reliability were established. PMSS is a 44-item five-point Likert-type scale. After each item is read in PMSS, marking is made by taking into account the degrees to the right of the relevant item, depending on whether this situation is within the period of "one week before menstruation". In scoring the scale, "Never" is evaluated as 1, "Very little" as 2, "Sometimes" as 3, "Often" as 4, and "Constantly" as 5 points. A score of 138 or higher indicates PMS.
Baseline
Women's Physical Activity Self-Worth Inventory
Time Frame: Baseline
The Women's Physical Activity Self-Worth Inventory (Women's Physical Activity Self-Worth Inventory), developed by Huberty J. et al. in 2013, is a 37-item multidimensional scale. Turkish version study, validity and reliability were done by Yutçiçek and Kömürcü in 2019. FAESQ is a 37-item Likert-type (Strongly Disagree (1), Disagree (2), Agree, (3), Strongly Agree (4)) scale that evaluates the non-physical aspects of physical activity-related self-worth in women. The total score obtained from the scale varies between 37 and 148. As the score increases, the sense of self-worth increases.
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nigde Omer Halisdemir University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ankara Yildirim Beyazıt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gürkan Demirtaş, MSc., Nigde Omer Halisdemir University
  • Principal Investigator: Arife Akbulut, MSc., Ankara Yildirim Beyazıt University
  • Principal Investigator: Havva Sümeyye Eroğlu, MSc., Gazi University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06.10.2022-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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