NCT05692479

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

January 11, 2023

Last Update Submit

March 22, 2023

Conditions

Keywords

Premenstrual syndromewomenself-worthphysical activity

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline

Study Arms (1)

Group 1 and Group 2

Women With and Without Premenstrual Syndrome

Other: Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data

Interventions

Premenstrual Syndrome Scale, Women's Physical Activity Self-Worth Inventory, Descriptive data

Group 1 and Group 2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenstrual syndrome occurs only in women.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University

Niğde, 51200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Gürkan Demirtaş, MSc.

    Niğde Ömer Halisdemir University

    PRINCIPAL INVESTIGATOR
  • Arife Akbulut, MSc.

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR
  • Havva Sümeyye Eroğlu, MSc.

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc. Lecturer

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

October 10, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations