Premenstrual SyndromeNCT05144568
The Effect of Nutrition Education on Premenstrual Syndrome
A study testing Nutrition education in people with Premenstrual Syndrome, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to examine the effect of nutritional education given to university students with premenstrual syndrome (PMS) on premenstrual symptom severity, nutrient intake and anthropometric measures. Our hypothesis is that nutrition education reduces symptoms in students with PMS. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2019to 30 Sep 2019
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the study
- be woman
- have a regular menstrual cycle
- be 18 years or older
Who cannot join
- have a chronic illness
- have been on a diet in the last 3 months
- using oral contraceptives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nutrition Education on Premenstrual Syndrome: Randomized Controlled Study
The aim of our study is to examine the effect of nutritional education given to university students with premenstrual syndrome (PMS) on premenstrual symptom severity, nutrient intake and anthropometric measures. Our hypothesis is that nutrition education reduces symptoms in students with PMS. The effect of nutrition education on premenstrual syndrome was evaluated. The sample for this study included 83 female students, with 43 in the experimental and 40 in the control group, who were studying at the health sciences faculty of a state university and met the inclusion criteria. Experimental and control groups were formed by randomized method. Nutrition training was given to the experimental group. Participant data were collected before and four months after nutrition training. The data were collected with the personal information form, Premenstrual Syndrome Scale and food consumption record form. Nutrient amounts were determined in the Nutrition Information System (BEBİS) program.
Read the detailed description
- INTRODUCTION Premenstrual Syndrome (PMS) is a condition in which physical, psychological and emotional symptoms related to the menstrual cycle of women are seen together. These symptoms experienced by many women occur before menstruation and disappear with menstrual bleeding. Imbalance in estrogen and progesterone levels, stress and malnutrition are among the factors affecting PMS. PMS, which has many symptoms such as changes in appetite, increased body weight, abdominal pain, back pain, headache, breast swelling and sensitivity, irritability, and fatigue, has incidence in Turkey in the range of 58.1% to 91.8%. It is known that individuals who do not exercise regularly, eat too much salt and sugar, and have high stress levels experience more PMS symptoms. While the presence of PMS in women causes an increase in health expenditures, loss of labor and low quality of life, in addition to these, it causes low concentration, absenteeism from school and academic failure. The etiology of premenstrual syndrome is not fully known, but one of the most emphasized reasons is hormone imbalance. Since the pathophysiology of PMS is not known exactly, the aim is to alleviate the severity of the symptoms during treatment of this syndrome. Non-pharmacological treatment methods such as exercise and diet are used. Studies reported that there is a positive relationship between increasing body mass index (BMI) and the risk of PMS. The incidence and severity of PMS is accepted to increase with simple carbohydrate consumption, and the aim is to reduce simple carbohydrate consumption and increase complex carbohydrate and fiber consumption in the treatment of PMS. It is reported that the consumption of foods with high fat content is a diet that increases the severity of PMS. Excessive consumption of salt, sugar, caffeine and alcohol negatively affects PMS. Studies conducted so far revealed various causes of PMS, and the effect of malnutrition on the etiology of PMS was mentioned. However, there are a few studies on providing nutrition training to individuals with PMS. Studies were conducted to show that excessive consumption of certain foods such as salt, sugar and caffeine, and insufficient intake of calcium, magnesium, B group vitamins and many other nutrients increase the severity of PMS. However, studies to reduce the severity of PMS by providing nutrition training to women with PMS are limited. This study was carried out to examine the effect of nutritional education given to nursing students studying at university on premenstrual symptom severity, nutrient intake and anthropometric measures. Research hypotheses: H1: Nutrition education has an impact on anthropometric measurements. H2: Nutrition education affects nutrient intake. H3: Nutrition education is effective in reducing the severity of premenstrual syndrome
- METHODS 2.1. Participants and Recruitment The population of this randomized controlled experimental study consisted of 117 female students who scored 111 and higher on the premenstrual syndrome scale (PMSS). The sample of the study included 83 nursing students, 43 in the experimental group and 40 in the control group, who agreed to participate in the study and were eligible for the inclusion criteria. The groups were created using the randomization technique, and a computer program was used for randomization (https://www.randomizer.org/). The rate of participation in the research was 71%. Female students who volunteered to participate in the study, who had regular menstrual cycles and were over 18 years old were included in the study. Students with chronic disease, dieting in the last 3 months and using oral contraceptives were excluded from the study.
The reason for conducting the study with female students is to minimize confounding factors such as pregnancy, lactation, and the use of oral contraceptives.
2.2. Study Design The first data in the study were collected between June 3 and June 10, 2019 with a questionnaire prepared by the researchers, the Premenstrual Syndrome Scale, and a 24-hour retrospective food consumption record. After the first evaluation, nutrition training was given to the experimental group, and no intervention was made to the control group. Anthropometric measurements of the participants and a 24-hour retrospective food consumption record were completed again 4 months after the nutrition training (between September 23 and September 30, 2019) and PMSS was re-applied. With the information obtained, the effect of nutrition education on anthropometric measurements, daily nutrients and premenstrual symptom severity was examined.
2.3. Instruments 2.3.1. Question form. In the questionnaire, there were questions about the students' age, class of education, current place of residence, anthropometric measurements including body weight, height, waist and hip circumference, smoking status, exercise status, coffee and salt consumption, skipping meals status, skipped meals, reason for skipping meals and what they consumed in the last 24 hours.
2.3.2. Anthropometric measurements. Anthropometric measurements including body weight, height, waist and hip circumference of the participants were taken. Participant weight was measured with a portable digital scale in light clothing and without shoes, and height without shoes was measured with the aid of a meter fixed to the wall with the feet side by side and on the head Frankfort plane. For the waist circumference measurement, the midpoint of the lowest rib of the individual and the crista iliac crest were found and the circumference passing through the midpoint was measured with an inelastic tape measure. Hip circumference was measured with a non-stretch tape measure at the highest point of the hip circumference, standing by the side of the participant. BMI was calculated by the ratio of body weight in kg to the square of height in meters.
2.3.3. Premenstrual syndrome scale. The Premenstrual Syndrome Scale (PMSS), developed by Gençdoğan20 based on DSM-III and DSM-IVR criteria, consists of 44 questions. The PMSS is Likert type and its items are scored between 1 and 5 points. Lowest points of 44 and highest points of 220 can be obtained on the PMSS. The scale has a total of 9 subscales: depressive feeling, anxiety, fatigue, irritability, depressive thoughts, pain, changes in appetite, changes in sleeping habits and swelling. A higher score on the scale indicates that the severity of premenstrual syndrome is high. When the score of the total PMSS and subscales is higher than 50% of the total score, it is considered to indicate PMS. In the original study, the Cronbach alpha value for the whole scale was 0.75, in this study the Cronbach alpha value was 0.90 before nutrition education and 0.96 after the education. For premenstrual syndrome subscales, the Cronbach alpha values before and after the intervention were depressive feeling 0.85-0.89, anxiety 0.77-0.86, fatigue 0.81-0.87, irritability 0.88-0.92, depressive thoughts 0.82-0.91, pain 0.74-0.79, changes in appetite 0.55-0.58, changes in sleeping habits 0.77-0.79 and swelling 0.85-0.81.
2.4. Intervention-Nutrition Education In the experimental group, 43 students were divided into 4 groups, and each group received an hour of nutrition education. The education was carried out in classrooms where the students were trained, supported by a power point presentation. Nutritional sources of nutrients were taught, the relationship of some specific foods such as salt and coffee with premenstrual syndrome, the number of meals, meal time and importance of body weight control in premenstrual syndrome were emphasized. On the 30th and 60th days after the nutrition education, an e-mail was sent to the participants to inform them about nutrition in order to reinforce the education.
2.5. Ethical Issues Before starting the study, permission was obtained from Gençdoğan to use the PMS scale. In order to conduct the research, permission of the institution was obtained from Ordu University where the research was conducted (decision dated 26 April 2019 and numbered ….). Ethics committee approval was obtained from Ordu University Non-Interventional Clinical Research Ethics Committee (May 23, 2019 and numbered 2019/82). After the participants were informed about the study, their informed written consent was obtained. In this study, the principles of the Declaration of Helsinki were followed.
- Conditions
- Premenstrual Syndrome
- Being tested
- Nutrition education
- Keywords
- premenstrual syndrome, nutritional status, nutrition education, nursing students, university students
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationOther
Nutrition education will be given to improve PMS
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Nutrition education will be given to participants with PMS in the experimental group. Receives: Other: Nutrition education |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of the nutrition education given to the experimental group was evaluated with the Premenstrual Syndrome Scale.
The Premenstrual Syndrome Scale consists of 44 questions. The PMSS is Likert type and its items are scored between 1 and 5 points. Lowest points of 44 and highest points of 220 can be obtained on the PMSS. The scale has a total of 9 subscales: depressive feeling, anxiety, fatigue, irritability, depressive thoughts, pain, changes in appetite, changes in sleeping habits and swelling. A higher score on the scale indicates that the severity of premenstrual syndrome is high. When the score of the total PMSS and subscales is higher than 50% of the total score, it is considered to indicate PMS.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start3 Jun 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu MATARACI DEĞİRMENCİ, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144568
- Sponsor's protocol ID
- orduüniversitesiDuyguMataracı1
- Status last verified
- Nov 2021
- First submitted
- 18 Oct 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition Education on Premenstrual Syndrome: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05144568
- Acronym / sponsor ID
- orduüniversitesiDuyguMataracı1
- Conditions
- Premenstrual Syndrome
- Keywords
- premenstrual syndrome, nutritional status, nutrition education, nursing students, university students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 3 Dec 2021 (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 aim of our study is to examine the effect of nutritional education given to university students with premenstrual syndrome (PMS) on premenstrual symptom severity, nutrient intake and anthropometric measures. Our hypothesis is that nutrition education reduces symptoms in students with PMS. The effect of nutrition education on premenstrual syndrome was evaluated. The sample for this study included 83 female students, with 43 in the experimental and 40 in the control group, who were studying at the health sciences faculty of a state university and met the inclusion criteria. Experimental and control groups were formed by randomized method. Nutrition training was given to the experimental group. Participant data were collected before and four months after nutrition training. The data were collected with the personal information form, Premenstrual Syndrome Scale and food consumption record form. Nutrient amounts were determined in the Nutrition Information System (BEBİS) program.
Detailed description
- INTRODUCTION Premenstrual Syndrome (PMS) is a condition in which physical, psychological and emotional symptoms related to the menstrual cycle of women are seen together. These symptoms experienced by many women occur before menstruation and disappear with menstrual bleeding. Imbalance in estrogen and progesterone levels, stress and malnutrition are among the factors affecting PMS. PMS, which has many symptoms such as changes in appetite, increased body weight, abdominal pain, back pain, headache, breast swelling and sensitivity, irritability, and fatigue, has incidence in Turkey in the range of 58.1% to 91.8%. It is known that individuals who do not exercise regularly, eat too much salt and sugar, and have high stress levels experience more PMS symptoms. While the presence of PMS in women causes an increase in health expenditures, loss of labor and low quality of life, in addition to these, it causes low concentration, absenteeism from school and academic failure. The etiology of premenstrual syndrome is not fully known, but one of the most emphasized reasons is hormone imbalance. Since the pathophysiology of PMS is not known exactly, the aim is to alleviate the severity of the symptoms during treatment of this syndrome. Non-pharmacological treatment methods such as exercise and diet are used. Studies reported that there is a positive relationship between increasing body mass index (BMI) and the risk of PMS. The incidence and severity of PMS is accepted to increase with simple carbohydrate consumption, and the aim is to reduce simple carbohydrate consumption and increase complex carbohydrate and fiber consumption in the treatment of PMS. It is reported that the consumption of foods with high fat content is a diet that increases the severity of PMS. Excessive consumption of salt, sugar, caffeine and alcohol negatively affects PMS. Studies conducted so far revealed various causes of PMS, and the effect of malnutrition on the etiology of PMS was mentioned. However, there are a few studies on providing nutrition training to individuals with PMS. Studies were conducted to show that excessive consumption of certain foods such as salt, sugar and caffeine, and insufficient intake of calcium, magnesium, B group vitamins and many other nutrients increase the severity of PMS. However, studies to reduce the severity of PMS by providing nutrition training to women with PMS are limited. This study was carried out to examine the effect of nutritional education given to nursing students studying at university on premenstrual symptom severity, nutrient intake and anthropometric measures. Research hypotheses: H1: Nutrition education has an impact on anthropometric measurements. H2: Nutrition education affects nutrient intake. H3: Nutrition education is effective in reducing the severity of premenstrual syndrome
- METHODS 2.1. Participants and Recruitment The population of this randomized controlled experimental study consisted of 117 female students who scored 111 and higher on the premenstrual syndrome scale (PMSS). The sample of the study included 83 nursing students, 43 in the experimental group and 40 in the control group, who agreed to participate in the study and were eligible for the inclusion criteria. The groups were created using the randomization technique, and a computer program was used for randomization (https://www.randomizer.org/). The rate of participation in the research was 71%. Female students who volunteered to participate in the study, who had regular menstrual cycles and were over 18 years old were included in the study. Students with chronic disease, dieting in the last 3 months and using oral contraceptives were excluded from the study.
The reason for conducting the study with female students is to minimize confounding factors such as pregnancy, lactation, and the use of oral contraceptives.
2.2. Study Design The first data in the study were collected between June 3 and June 10, 2019 with a questionnaire prepared by the researchers, the Premenstrual Syndrome Scale, and a 24-hour retrospective food consumption record. After the first evaluation, nutrition training was given to the experimental group, and no intervention was made to the control group. Anthropometric measurements of the participants and a 24-hour retrospective food consumption record were completed again 4 months after the nutrition training (between September 23 and September 30, 2019) and PMSS was re-applied. With the information obtained, the effect of nutrition education on anthropometric measurements, daily nutrients and premenstrual symptom severity was examined.
2.3. Instruments 2.3.1. Question form. In the questionnaire, there were questions about the students' age, class of education, current place of residence, anthropometric measurements including body weight, height, waist and hip circumference, smoking status, exercise status, coffee and salt consumption, skipping meals status, skipped meals, reason for skipping meals and what they consumed in the last 24 hours.
2.3.2. Anthropometric measurements. Anthropometric measurements including body weight, height, waist and hip circumference of the participants were taken. Participant weight was measured with a portable digital scale in light clothing and without shoes, and height without shoes was measured with the aid of a meter fixed to the wall with the feet side by side and on the head Frankfort plane. For the waist circumference measurement, the midpoint of the lowest rib of the individual and the crista iliac crest were found and the circumference passing through the midpoint was measured with an inelastic tape measure. Hip circumference was measured with a non-stretch tape measure at the highest point of the hip circumference, standing by the side of the participant. BMI was calculated by the ratio of body weight in kg to the square of height in meters.
2.3.3. Premenstrual syndrome scale. The Premenstrual Syndrome Scale (PMSS), developed by Gençdoğan20 based on DSM-III and DSM-IVR criteria, consists of 44 questions. The PMSS is Likert type and its items are scored between 1 and 5 points. Lowest points of 44 and highest points of 220 can be obtained on the PMSS. The scale has a total of 9 subscales: depressive feeling, anxiety, fatigue, irritability, depressive thoughts, pain, changes in appetite, changes in sleeping habits and swelling. A higher score on the scale indicates that the severity of premenstrual syndrome is high. When the score of the total PMSS and subscales is higher than 50% of the total score, it is considered to indicate PMS. In the original study, the Cronbach alpha value for the whole scale was 0.75, in this study the Cronbach alpha value was 0.90 before nutrition education and 0.96 after the education. For premenstrual syndrome subscales, the Cronbach alpha values before and after the intervention were depressive feeling 0.85-0.89, anxiety 0.77-0.86, fatigue 0.81-0.87, irritability 0.88-0.92, depressive thoughts 0.82-0.91, pain 0.74-0.79, changes in appetite 0.55-0.58, changes in sleeping habits 0.77-0.79 and swelling 0.85-0.81.
2.4. Intervention-Nutrition Education In the experimental group, 43 students were divided into 4 groups, and each group received an hour of nutrition education. The education was carried out in classrooms where the students were trained, supported by a power point presentation. Nutritional sources of nutrients were taught, the relationship of some specific foods such as salt and coffee with premenstrual syndrome, the number of meals, meal time and importance of body weight control in premenstrual syndrome were emphasized. On the 30th and 60th days after the nutrition education, an e-mail was sent to the participants to inform them about nutrition in order to reinforce the education.
2.5. Ethical Issues Before starting the study, permission was obtained from Gençdoğan to use the PMS scale. In order to conduct the research, permission of the institution was obtained from Ordu University where the research was conducted (decision dated 26 April 2019 and numbered ….). Ethics committee approval was obtained from Ordu University Non-Interventional Clinical Research Ethics Committee (May 23, 2019 and numbered 2019/82). After the participants were informed about the study, their informed written consent was obtained. In this study, the principles of the Declaration of Helsinki were followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Nutrition educationNutrition education will be given to participants with PMS in the experimental group. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteer to participate in the study
- be woman
- have a regular menstrual cycle
- be 18 years or older
Key exclusion criteria (3 listed)
- have a chronic illness
- have been on a diet in the last 3 months
- using oral contraceptives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition educationNutrition education will be given to improve PMS | Other | experimental group |
Primary outcome
The effectiveness of the nutrition education given to the experimental group was evaluated with the Premenstrual Syndrome Scale.
Time frame: 3 months
The Premenstrual Syndrome Scale consists of 44 questions. The PMSS is Likert type and its items are scored between 1 and 5 points. Lowest points of 44 and highest points of 220 can be obtained on the PMSS. The scale has a total of 9 subscales: depressive feeling, anxiety, fatigue, irritability, depressive thoughts, pain, changes in appetite, changes in sleeping habits and swelling. A higher score on the scale indicates that the severity of premenstrual syndrome is high. When the score of the total PMSS and subscales is higher than 50% of the total score, it is considered to indicate PMS.
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 3 Dec 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education in people with Premenstrual Syndrome, run by Ordu University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 3 Dec 2021. 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 Turkey (Türkiye). 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?
The effectiveness of the nutrition education given to the experimental group was evaluated with the Premenstrual Syndrome Scale. (time frame: 3 months). 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 3 Dec 2021.