A Multidimensional Study of Premenstrual Syndrome and Body Image

Sleep Clinical Trial

Official title:

A Multidimensional Study of Premenstrual Syndrome, Body Image, Physical Activity and Sleep Quality Among Women in Reproductive Age

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06146673
• Other study ID #: BM/23899-1/2023
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: University of Pecs
• Contact: Olívia Dózsa-Juhász, Bsc
• Phone: +36205472290
• Email: dj.olivia97[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this cross-sectional study is to investigate the influencing factors of body image in women of reproductive age. The main question[s] it aims to answer are: - Is there a connection between physical activity, body mass index and body image? - Is there a connection between body image, premenstrual syndrome and sleep quality? Participants will fill out a complex online questionnaire.

Description:

During the research, the researchers use a quantitative method, in which the participants fill out the Knowledge of the Female Body Scale, the Global Physical Activity Questionnaire, the Body Appreciation Scale, the Sleep Quality Scale and the Premenstrual Assessment Form Short Form, as well as a general health status questionnaire. and a self-made questionnaire containing socio-demographic questions. In the course of the research, we form a sub-sample, on which we carry out further instrumental tests to monitor body composition and physical activity. The number of participants is approx. There will be 500 women between the ages of 18 and 45, who will be selected through targeted sampling. During the research, the data are processed in the SPSS v28.0 program and the following statistical methods are used: Kolmogorov-Smirnov and Shapiro-Wilk normality tests, Spearman and Pearson correlation analysis, Pearson chi-square test, linear regression analysis. During the research, the safety of the participants and the ethical rules are strictly observed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 329
• Est. completion date: August 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• women
• between the ages of 18-45 years
• regular menstruation

Exclusion Criteria:

• older than 45 years
• pregnancy
• amenorrhoea
• premature ovarian failure

Related Conditions & MeSH terms

• Body Image
• Physical Inactivity
• Premenstrual Syndrome
• Sleep
• Syndrome

Locations

Country	Name	City	State
Hungary	University of Pécs	Pécs	Baranya

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Image	points; Body Appreciation Scale (13 item version, 4 subscales); 1-5 point scale, minimum score: 13 points; maximum score: 65 points, the higher the points the worse the body image	1 day
Secondary	Global Physical Activity Questionnaire	MET/min 16 questions Assessing work-, travel-related and recreational physical activity and the hours spent sitting.	1 week
Secondary	Sleep Quality	points; Sleep Quality Scale (28 items, 6 subscales); 0-3 point scale, minimum score: 0 points; maximum score: 84 points, the higher the points the worse the sleep quality	1 day
Secondary	Premenstrual syndrome	points; Premenstrual Assessment Form Short Form Questionnaire (10 item version); 1-6 point scale, minimum score: 10 points; maximum score: 60 points, the higher the points the worse the symptoms	1 day
Secondary	Body mass index	kg/m^2	1 day
Secondary	Knowledge of he Female Body	points; Knowledge of the Female Body Scale 26 questions 0-17=low knowledge 18-26=high knowledge	1 day
Secondary	Health Literacy	points; Brief Health Literacy Screening Tool (4 questions) 1-5 point scale, minimum score: 4 points; maximum score: 20 points, 4-12 points=inadequate 13-16=marginal 17-20=adequate	1 day