Premenstrual SyndromeNCT05692479
Premenstrual Syndrome and Physical Activity Self-Worth
An observational study of Premenstrual Syndrome, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2022to 28 Feb 2023
- How long will I take part?
- 1 Day
- 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 35 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Volunteer to participate in the study
- Being 18-35 years old
- Being women
- To be menstruating
Who cannot join
- Evaluation form missing
- Not menstruating for 12 months or more
- Having any psychological diagnosis
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data
- Keywords
- Premenstrual syndrome, women, self-worth, physical activity
- Medical subject headings
- Premenstrual Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive dataOther
Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data
| Study group | Role | What they receive |
|---|---|---|
| Group 1 and Group 2 | Women With and Without Premenstrual Syndrome Receives: Other: Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Data
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.
Measured: Baseline
Premenstrual Syndrome Scale
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.
Measured: Baseline
Women's Physical Activity Self-Worth Inventory
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start10 Oct 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Responsible party
- Principal investigator, Asli Celik, Nigde Omer Halisdemir University
- Investigators
- Gürkan Demirtaş, MSc., Principal investigator, Niğde Ömer Halisdemir UniversityArife Akbulut, MSc., Principal investigator, Ankara Yildirim Beyazıt UniversityHavva Sümeyye Eroğlu, MSc., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692479
- Sponsor's protocol ID
- 06.10.2022-14
- Status last verified
- Mar 2023
- First submitted
- 11 Jan 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physical Activity Self Worth of Women With and Without Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT05692479
- Acronym / sponsor ID
- 06.10.2022-14
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual syndrome, women, self-worth, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 20 Jan 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 and Group 2 | – | Other: Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive dataWomen With and Without Premenstrual Syndrome |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Volunteer to participate in the study
- Being 18-35 years old
- Being women
- To be menstruating
Key exclusion criteria (4 listed)
- Evaluation form missing
- Not menstruating for 12 months or more
- Having any psychological diagnosis
- Being pregnant
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 |
|---|---|---|
| Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive dataPremenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data | Other | Group 1 and Group 2 |
Primary outcome
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.
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.
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.
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 23 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Gürkan Demirtaş, MSc. principal investigator
Niğde Ömer Halisdemir University
Arife Akbulut, MSc. principal investigator
Ankara Yildirim Beyazıt University
Havva Sümeyye Eroğlu, MSc. principal investigator
Gazi University
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 Premenstrual Syndrome, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 23 Mar 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 Turkey (Türkiye). 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?
Descriptive Data (time frame: Baseline). 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?
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 23 Mar 2023.