Premenstrual SyndromeNCT05811130
Premenstrual Syndrome and Its Influencing Factors Such as Physical Activity, Perceived Stress and Mental Status
An observational study of Premenstrual Syndrome, run by University of Pecs at 1 site in Hungary.
Trial summary
Our research aimed to investigate how a sedentary lifestyle, body mass index, depression, and stress affect the severity of PMS symptoms and how the listed factors influence each other. 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
- Premenstrual Syndrome
- How many people
- 204 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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.
About this study
Official title: Examinating Premenstrual Syndrome and Its Influencing Factors Such as Physical Activity, Perceived Stress and Mental Status - Cross Sectional Study
Our research aimed to investigate how a sedentary lifestyle, body mass index, depression, and stress affect the severity of PMS symptoms and how the listed factors influence each other.
Read the detailed description
The measuring instrument used was compiled from standard and self-made questionnaires.
The data collection spanned 6 months on the Google Forms platform. The sampling procedure used was convenience sampling. 500 people were invited to fill out the questionnaire, which was sent to women's health-themed groups on social media, and it was also sent to universities in Hungary.
At the same time as the cross-sectional research, the investigators formed two groups concerning the results of the Premenstrual Assessment Form questionnaire: a case group and a control group. The obtained results were examined for both the experimental and control groups.
The self-edited part of the examining tool consisted of general questions (socio-demographic, women's and public health, anthropometric) and standardized questionnaires integrated into the online questionnaire.
The investigators assessed the age of the subjects and calculated their body mass index (BMI) by assessing the participants weight and height.
During the questionnaire, The investigators covered the lifestyle of the subjects: smoking, coffee, alcohol, and drug consumption habits. The investigators asked about the characteristics of the menstrual cycle, such as the presence of pain and cramps or the regularity of the cycle (a cycle between 21-35 days was considered regular). The investigators have also assessed the presence of pregnancy and breastfeeding.
In general questions about physical activity, the investigators collected data on how often subjects engage in physical activity.
The General Health Questionnaire-12
To assess the presence of depression, the investigators used Goldberg's 12-item General Health Questionnaire (GHQ-12). The original questionnaire consisted of 60 questions, and several versions have proven useful over time. The questionnaire assesses mental health through 4 subscales: somatic symptoms, anxiety and insomnia, social dysfunctions, and severe depression. The participants could answer the 12 questions on a scale from 0 to 3. Two scoring systems can be used when evaluating the GHQ-12: the so-called bimodal scoring (0-0-1-1) and the other is Likert scoring (0-1-2-3). The cut-off point limit for the bimodal scoring method is 2/3, and the maximum score that can be obtained is 12; for the Likert scale, it is 8/9, and the top score is 36.
The Perceived Stress Scale
The investigators used the Hungarian-language, validated version of the Perceived Stress Scale (PSS) to assess perceived stress. The questionnaire gives the investigators feedback on the stress level experienced during the past month. The questionnaire consists of 10 questions, which respondents can answer on a 5-point scale from 0-4, so the lowest possible score is 0, and the highest is 40. During the evaluation, based on the total scores, the respondents can be divided into 3 categories: 0-13 points = low level of perceived stress; 14-26 points = moderate perceived stress; 27-40 points = high level of perceived stress.
The International Physical Activity Questionnaire-Short Form
The investigators used the shortened version of the International Physical Activity Questionnaire (IPAQ-SF) to assess physical activity, validated in Hungarian. The questionnaire assesses the number of days and hours the subjects spend in heavy, moderate, or light physical work and examines the time all activities spent walking, lying down, and sitting for a period of one week.
The Premenstrual Assessment Form - Short Form
The investigators used the shortened version of the Premenstrual Assessment Form (PAF-SF), containing 10 questions translated into Hungarian to assess premenstrual symptoms. The questionnaire consists of 3 subscales; the first is called "Affect," which asks about increased irritability and bad mood, sad mood, stress, and overwork. The second subscale asks the participant about "Water retention," such as questions about edema and limb swelling, bloating, and weight gain. The third and last subscale assesses the existence of "Pain." It asks about lower abdominal cramps, back pain, joint pain, and pain caused by tense breasts. It is important to emphasize that all questions ask about the 7-14 days before menstruation and that the respondents can answer on a scale from one to six, the values of which are as follows: 1=uncharacteristic or no change; 2=minimal change; 3=slight change; 4=moderate change; 5=severe change; 6=very severe change. The total score can be calculated based on the scores given to these questions. The minimum number of points that can be obtained is 10, and the maximum number that can be obtained is 60. According to several international literature, the diagnostic point limit is 27, so this was used to evaluate the obtained data.
After evaluating the results of the PAF questionnaire, the investigators created a control and a case group to examine individual factors depending on the symptoms of PMS.
Among the applied statistical calculations, the minimum, maximum, mean (± standard deviation), and median (interquartile range) functions were used to characterize the descriptive statistics. During the normality test, the investigators used the Kolmogorov-Smirnov test, based on the results of which Spearman correlation analysis, independent sample T-test, Mann-Whitney U test, and Pearson chi-square test were performed to test the hypotheses.
The statistical data analysis software used in the study included Microsoft Excel 2016 and IBM SPSS version 28.0 (SPSS Inc., Chicago, IL, USA).
The level of significance was defined as p<0.05.
- Conditions
- Premenstrual Syndrome
- Keywords
- physical activity, perceived stress, mental health
- Medical subject headings
- Premenstrual Syndrome, Motor Activity, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (4)
Physical activity
minutes/week
Measured: 1 day
Perceived Stress
- points;
- Perceived Stress Scale;
- 10 questions
- 0-4 point scale,
- minimum score: 0 points;
- maximum score: 40 points,
- the higher the points, the worse the symptoms:
- 0-13 points: low level perceived stress
- 14-26 points: medium level perceived stress
- 27-40 points: high level perceived stress
Measured: 1 day
Mental Health
- points;
- General Health Questionnaire-12 items version;
- 12 questions
- 0-3 point scale,
- two scoring methods: bimodal (0-0-1-1) and Likert-type (0-1-2-3).
- the cut-off point for bimodal scoring is 3, and the maximum possible score is 12 points.
- for Likert scoring, the maximum score is 36, and the cut-off point is 9.
Measured: 1 day
BMI
kg/m^2
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 posted13 Apr 2023
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olívia Dózsa-Juhász, BSc, Study chair, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811130
- Sponsor's protocol ID
- 9386/2022
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examinating Premenstrual Syndrome and Its Influencing Factors Such as Physical Activity, Perceived Stress and Mental Status - Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05811130
- Acronym / sponsor ID
- 9386/2022
- Conditions
- Premenstrual Syndrome
- Keywords
- physical activity, perceived stress, mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Apr 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.
Our research aimed to investigate how a sedentary lifestyle, body mass index, depression, and stress affect the severity of PMS symptoms and how the listed factors influence each other.
Detailed description
The measuring instrument used was compiled from standard and self-made questionnaires.
The data collection spanned 6 months on the Google Forms platform. The sampling procedure used was convenience sampling. 500 people were invited to fill out the questionnaire, which was sent to women's health-themed groups on social media, and it was also sent to universities in Hungary.
At the same time as the cross-sectional research, the investigators formed two groups concerning the results of the Premenstrual Assessment Form questionnaire: a case group and a control group. The obtained results were examined for both the experimental and control groups.
The self-edited part of the examining tool consisted of general questions (socio-demographic, women's and public health, anthropometric) and standardized questionnaires integrated into the online questionnaire.
The investigators assessed the age of the subjects and calculated their body mass index (BMI) by assessing the participants weight and height.
During the questionnaire, The investigators covered the lifestyle of the subjects: smoking, coffee, alcohol, and drug consumption habits. The investigators asked about the characteristics of the menstrual cycle, such as the presence of pain and cramps or the regularity of the cycle (a cycle between 21-35 days was considered regular). The investigators have also assessed the presence of pregnancy and breastfeeding.
In general questions about physical activity, the investigators collected data on how often subjects engage in physical activity.
The General Health Questionnaire-12
To assess the presence of depression, the investigators used Goldberg's 12-item General Health Questionnaire (GHQ-12). The original questionnaire consisted of 60 questions, and several versions have proven useful over time. The questionnaire assesses mental health through 4 subscales: somatic symptoms, anxiety and insomnia, social dysfunctions, and severe depression. The participants could answer the 12 questions on a scale from 0 to 3. Two scoring systems can be used when evaluating the GHQ-12: the so-called bimodal scoring (0-0-1-1) and the other is Likert scoring (0-1-2-3). The cut-off point limit for the bimodal scoring method is 2/3, and the maximum score that can be obtained is 12; for the Likert scale, it is 8/9, and the top score is 36.
The Perceived Stress Scale
The investigators used the Hungarian-language, validated version of the Perceived Stress Scale (PSS) to assess perceived stress. The questionnaire gives the investigators feedback on the stress level experienced during the past month. The questionnaire consists of 10 questions, which respondents can answer on a 5-point scale from 0-4, so the lowest possible score is 0, and the highest is 40. During the evaluation, based on the total scores, the respondents can be divided into 3 categories: 0-13 points = low level of perceived stress; 14-26 points = moderate perceived stress; 27-40 points = high level of perceived stress.
The International Physical Activity Questionnaire-Short Form
The investigators used the shortened version of the International Physical Activity Questionnaire (IPAQ-SF) to assess physical activity, validated in Hungarian. The questionnaire assesses the number of days and hours the subjects spend in heavy, moderate, or light physical work and examines the time all activities spent walking, lying down, and sitting for a period of one week.
The Premenstrual Assessment Form - Short Form
The investigators used the shortened version of the Premenstrual Assessment Form (PAF-SF), containing 10 questions translated into Hungarian to assess premenstrual symptoms. The questionnaire consists of 3 subscales; the first is called "Affect," which asks about increased irritability and bad mood, sad mood, stress, and overwork. The second subscale asks the participant about "Water retention," such as questions about edema and limb swelling, bloating, and weight gain. The third and last subscale assesses the existence of "Pain." It asks about lower abdominal cramps, back pain, joint pain, and pain caused by tense breasts. It is important to emphasize that all questions ask about the 7-14 days before menstruation and that the respondents can answer on a scale from one to six, the values of which are as follows: 1=uncharacteristic or no change; 2=minimal change; 3=slight change; 4=moderate change; 5=severe change; 6=very severe change. The total score can be calculated based on the scores given to these questions. The minimum number of points that can be obtained is 10, and the maximum number that can be obtained is 60. According to several international literature, the diagnostic point limit is 27, so this was used to evaluate the obtained data.
After evaluating the results of the PAF questionnaire, the investigators created a control and a case group to examine individual factors depending on the symptoms of PMS.
Among the applied statistical calculations, the minimum, maximum, mean (± standard deviation), and median (interquartile range) functions were used to characterize the descriptive statistics. During the normality test, the investigators used the Kolmogorov-Smirnov test, based on the results of which Spearman correlation analysis, independent sample T-test, Mann-Whitney U test, and Pearson chi-square test were performed to test the hypotheses.
The statistical data analysis software used in the study included Microsoft Excel 2016 and IBM SPSS version 28.0 (SPSS Inc., Chicago, IL, USA).
The level of significance was defined as p<0.05.
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
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
4 secondary outcomes
Physical activity
Time frame: 1 day
Perceived Stress
Time frame: 1 day
Mental Health
Time frame: 1 day
BMI
Time frame: 1 day
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 18 Apr 2023.
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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.
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 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: finished, as of the sponsor's last update on 18 Apr 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?
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?
Premenstrual syndrome (time frame: 1 day). 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 18 Apr 2023.