Body ImageNCT06146673
A Multidimensional Study of Premenstrual Syndrome and Body Image
An observational study of Body Image and Premenstrual Syndrome, run by University of Pecs at 1 site in Hungary.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image, Premenstrual Syndrome, Sleep
- How many people
- 329 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2023to 31 Aug 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women between the ages of 18-45 who reported symptoms of PMS during the period of parameterization of the target group
Who may be able to join
- women
- between the ages of 18-45 years
- regular menstruation
Who cannot join
- older than 45 years
- pregnancy
- amenorrhoea
- premature ovarian failure
Trial locations and contacts
1 site in 1 country.
Alexandra Makai, PhD contact
Hungary1 site, 1 recruiting
- Recruiting
University of Pécs
Pécs, Baranya, 7621
Olívia Dózsa-Juhász, +36205472290, dj.olivia97@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Body Image, Premenstrual Syndrome, Sleep, Physical Inactivity
- Keywords
- physical activity, premenstrual syndrome, body mass index, 24 hour movement behaviour, sleep quality, body image
- Medical subject headings
- Premenstrual Syndrome, Sedentary Behavior, Motor Activity, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (6)
Global Physical Activity Questionnaire
MET/min 16 questions Assessing work-, travel-related and recreational physical activity and the hours spent sitting.
Measured: 1 week
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
Measured: 1 day
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
Measured: 1 day
Body mass index
kg/m^2
Measured: 1 day
Knowledge of he Female Body
points; Knowledge of the Female Body Scale 26 questions 0-17=low knowledge 18-26=high knowledge
Measured: 1 day
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Sep 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dózsa-Juhász Olívia, University of Pecs
- Investigators
- Olívia Dózsa-Juhász, BSc, Study chair, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146673
- Sponsor's protocol ID
- BM/23899-1/2023
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Premusz V, Kovacs KA, Skriba E, Tandor Z, Szmatona G, Dozsa-Juhasz O. Socio-Economic and Health Literacy Inequalities as Determinants of Women's Knowledge about Their Reproductive System: A Cross-Sectional Study. Epidemiologia (Basel). 2024 Sep 26;5(4):627-642. doi: 10.3390/epidemiologia5040044.
PubMed 39449387
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidimensional Study of Premenstrual Syndrome, Body Image, Physical Activity and Sleep Quality Among Women in Reproductive Age
- ClinicalTrials.gov ID
- NCT06146673
- Acronym / sponsor ID
- BM/23899-1/2023
- Conditions
- Body Image, Premenstrual Syndrome, Sleep, Physical Inactivity
- Keywords
- physical activity, premenstrual syndrome, body mass index, 24 hour movement behaviour, sleep quality, body image
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 329 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 27 Nov 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women between the ages of 18-45 who reported symptoms of PMS during the period of parameterization of the target group
Key inclusion criteria (3 listed)
- women
- between the ages of 18-45 years
- regular menstruation
Key exclusion criteria (4 listed)
- older than 45 years
- pregnancy
- amenorrhoea
- premature ovarian failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Global Physical Activity Questionnaire
Time frame: 1 week
Sleep Quality
Time frame: 1 day
Premenstrual syndrome
Time frame: 1 day
Body mass index
Time frame: 1 day
Knowledge of he Female Body
Time frame: 1 day
Health Literacy
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Derived from this study: PubMed 39449387Premusz V, Kovacs KA, Skriba E, Tandor Z, Szmatona G, Dozsa-Juhasz O. Socio-Economic and Health Literacy Inequalities as Determinants of Women's Knowledge about Their Reproductive System: A Cross-Sectional Study. Epidemiologia (Basel). 2024 Sep 26;5(4):627-642. doi: 10.3390/epidemiologia5040044.
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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.
Alexandra Makai, PhD contact
Olívia Dózsa-Juhász, BSc study chair
University of Pecs
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 Body Image and Premenstrual Syndrome, run by University of Pecs at 1 site in Hungary.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Nov 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olívia Dózsa-Juhász, Bsc (+36205472290, dj.olivia97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Image (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06146673, which also lists 1 linked publication.
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 27 Nov 2023.