- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06146673
A Multidimensional Study of Premenstrual Syndrome and Body Image
November 23, 2023 updated by: Dózsa-Juhász Olívia, University of Pecs
A Multidimensional Study of Premenstrual Syndrome, Body Image, Physical Activity and Sleep Quality Among Women in Reproductive Age
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.
Study Overview
Status
Recruiting
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
329
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: Olívia Dózsa-Juhász, Bsc
- Phone Number: +36205472290
- Email: dj.olivia97@gmail.com
Study Contact Backup
- Name: Alexandra Makai, PhD
- Email: alexandra.makai@etk.pte.hu
Study Locations
-
-
Baranya
-
Pécs, Baranya, Hungary, 7621
- Recruiting
- University of Pécs
-
Contact:
- Olívia Dózsa-Juhász
- Phone Number: +36205472290
- Email: dj.olivia97@gmail.com
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
women between the ages of 18-45 who reported symptoms of PMS during the period of parameterization of the target group
Description
Inclusion Criteria:
- women
- between the ages of 18-45 years
- regular menstruation
Exclusion Criteria:
- older than 45 years
- pregnancy
- amenorrhoea
- premature ovarian failure
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 |
|---|---|---|
|
Body Image
Time Frame: 1 day
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Physical Activity Questionnaire
Time Frame: 1 week
|
MET/min 16 questions Assessing work-, travel-related and recreational physical activity and the hours spent sitting.
|
1 week
|
|
Sleep Quality
Time Frame: 1 day
|
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
|
|
Premenstrual syndrome
Time Frame: 1 day
|
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
|
|
Body mass index
Time Frame: 1 day
|
kg/m^2
|
1 day
|
|
Knowledge of he Female Body
Time Frame: 1 day
|
points; Knowledge of the Female Body Scale 26 questions 0-17=low knowledge 18-26=high knowledge
|
1 day
|
|
Health Literacy
Time Frame: 1 day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Olívia Dózsa-Juhász, BSc, University of Pécs
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)
September 1, 2023
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
August 31, 2024
Study Registration Dates
First Submitted
November 17, 2023
First Submitted That Met QC Criteria
November 23, 2023
First Posted (Actual)
November 27, 2023
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BM/23899-1/2023
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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