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Premenstrual SyndromePremenstrualNCT06105567

The Effect of Education Given According to the Health Promotion Model on Premenstrual Symptoms, Emotional Eating Behavior and Perceived Stress

A study testing Training given according to the health promotion model by applying the Philips 66 technique in people with Premenstrual Syndrome and Emotional Disorder, run by Kafkas University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nurses have important duties in this regard due to their roles such as health education, health protection, development and consultancy. In this study, it is thought that the training given according to the health promotion model will both create a resource for nurses and contribute to the literature with the results… Read more about this study

Who is it for?
Ages 18 to 30 years, women only
What is being tested?
Training given according to the health promotion model by applying the Philips 66 technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Oct 2023to 7 Oct 2024
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 to 30 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Getting over 110 points from the PMS scale,
  • Experiencing at least five PMS symptoms every month,
  • Not having had sexual intercourse
  • Regular menstruation, (regular menstruation (between 21-35 days))
  • Not having any chronic disease,
  • Not using any method to cope with PMS
  • Not taking Hormone Replacement Therapy
  • Women who agreed to participate in the study were included in the study group.

Who cannot join

  • • Having had sexual intercourse,
  • Allergy,
  • Irregular menstruation,
  • Not having regular menstrual periods in the last three months,
  • Having received a psychiatric diagnosis,
  • Do not have any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
  • Using contraceptive medication,
  • 1st and 4th year nursing and midwifery students

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kafkas University

    Kars, Kars, 36100

Other trials in Turkey (Türkiye)

About this study

Nurses have important duties in this regard due to their roles such as health education, health protection, development and consultancy.

In this study, it is thought that the training given according to the health promotion model will both create a resource for nurses and contribute to the literature with the results obtained by applying this training to people experiencing PMS.The research will be conducted as a pretest-posttest randomized controlled study.

Read more

H1: Education given according to the health promotion model has an effect on premenstrual symptoms, emotional eating behavior and perceived stress.

H0: Education given according to the health promotion model has no effect on premenstrual symptoms, emotional eating behavior and perceived stress.

The total number of students in the research population is 330.In the G*Power 3.1.9.7 program, for the effect size t test, d = 0.94, alpha (α) = 0.05, and power (1-β) = 0.95, and the minimum total sample number was determined as 52, experimental group: 26, control group: 26. . However, taking into account the losses in the study, a total of 60 people will be included in the study. (experiment:30, control:30).

The first group will be divided into the group trained according to the health promotion model using the Philips 66 technique, and the second group will be divided into the control group.

Read the detailed description

Changes that gradually disappear with the onset of menstruation in women are called premenstrual syndrome.In this syndrome, anxiety, irritability, lack of concentration, depression, mood swings, drowsiness, sleep disturbance, breast tenderness, appetite change, bloating, headache, weight gain, abdominal pain, fatigue and gastrointestinal symptoms are observed. Since these symptoms negatively affect both the work and personal lives of women, safe and effective treatments are needed. In this case, many women report using exercise as a strategy to help them cope with PMS, and exercise is often recommended for symptom management.PMS can also play a role in symptoms by affecting the individual's food choices. Emotional eating behavior is defined as a person's use of food as an escape from negative emotions and can lead to many conditions such as obesity, eating disorders and hormonal problems. Health promotion means increasing one's control over one's health by improving one's own health. It enables the individual to improve their physical and social environment, change their behavior, and reach the best level of physical and mental health. Philips 66 technique is a process based on active learning, problem and collaborative learning theory, student-centered, and uses the best learning techniques to improve students' performance and realize meaningful learning activity. It is among the responsibilities of healthcare personnel to identify the factors that negatively affect women's lives in order to ensure continuity of health, ease of premenstrual symptoms, and to use the findings to improve women's health. Nurses have important duties in this regard due to their roles such as health education, health protection, development and consultancy. In this study, it is thought that the training given according to the health promotion model will both create a resource for nurses and contribute to the literature with the results obtained by applying this training to people experiencing PMS.Nurses have important duties in this regard due to their roles such as health education, health protection, development and consultancy.In this study, it is thought that the training given according to the health promotion model will both create a resource for nurses and contribute to the literature with the results obtained by applying this training to people experiencing PMS.The research will be conducted as a pretest-posttest randomized controlled study.

H1: Education given according to the health promotion model has an effect on premenstrual symptoms, emotional eating behavior and perceived stress.

H0: Education given according to the health promotion model has no effect on premenstrual symptoms, emotional eating behavior and perceived stress.

The total number of students in the research population is 330.In the G*Power 3.1.9.7 program, for the effect size t test, d = 0.94, alpha (α) = 0.05, and power (1-β) = 0.95, and the minimum total sample number was determined as 52, experimental group: 26, control group: 26. . However, taking into account the losses in the study, a total of 60 people will be included in the study. (experiment:30, control:30).

The first group will be divided into the group trained according to the health promotion model using the Philips 66 technique, and the second group will be divided into the control group.In the first stage, the "Premenstrual Syndrome Scale" will be applied to the students and the students will be placed in the experimental and control groups. In the second stage, Personal Information Form, PMS Scale, Premenstrual Eating Habits Form, Healthy Lifestyle Behaviors Scale, Emotional Eating Scale, Perceived Stress Scale and Visual Vissual Pain Scale will be applied to the students in this group before training. Data will be collected by face-to-face research method. Premenstrual syndrome periods will be determined by creating a menstrual cycle calendar for the participants. In the third stage, students in the experimental group will be trained with the first powerpoint presentation. Then brochures will be distributed. It will be applied according to the Philips 66 technique. In the fourth stage, 4 weeks after the first training, general reminder training will be given online during students' pms periods. In the fifth stage, 4 weeks after the second training, survey forms will be filled out by the experimental group and the control group.

Being tested
Training given according to the health promotion model by applying the Philips 66 technique
Keywords
premenstrual syndrome, emotional eating, health promotion model
Medical subject headings
Premenstrual Syndrome, Emotional Eating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training given according to the health promotion model by applying the Philips 66 techniqueBehavioural

    Also called control group, health promotion model, Philips 66 technique

    The Effect of Education Given According to the Health Promotion Model on Premenstrual Symptoms, Emotional Eating Behavior and Perceived Stress

Study groups in NCT06105567
Study groupRoleWhat they receive
Effect of Education on Premenstrual Symptoms, Emotional Eating Behavior and Perceived StressExperimentalStudents who score over 110 on the premenstrual syndrome scale and meet the study criteria will be included in the experimental and control groups. Personal Information Form, PMS Scale, Premenstrual Eating Habits Form, Healthy Lifestyle Behaviors Scale, Emotional Eating Scale, Perceived Stress Scale and Visual Visual Pain Scale will be administered to the students in this group before the training. Premenstrual syndrome periods will be determined by creating a menstrual cycle calendar for the participants. Students will be trained with their first powerpoint presentation. Afterwards, brochures will be distributed. It will be applied according to the Philips 66 technique. 4 weeks after the first training, students will be given general reminder training online during pms periods. Survey forms will be filled out by the group 4 weeks after the second training.
Receives: Behavioral: Training given according to the health promotion model by applying the Philips 66 technique
control groupNo interventionStudents who score over 110 on the premenstrual syndrome scale and meet the study criteria will be included in the experimental and control groups. Students in this group will not receive training and will be administered the Personal Information Form, PMS Scale, Premenstrual Eating Habits Form, Healthy Lifestyle Behaviors Scale, Emotional Eating Scale, Perceived Stress Scale and Visual Vissual Pain Scale. Data will be collected by face-to-face research method. Survey forms will be filled out by the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Premenstrual Syndrome Scale (PMSS)

    Participants in the study will be asked to fill out this scale in the 1st and 8th weeks. Women with premenstrual syndrome will be included in the study. The total score is obtained from the sum of the scores from all sub-dimensions. A minimum of 44 points and a maximum of 220 points can be obtained from the scale. An increase in the score obtained from the scale indicates that the intensity of the symptoms increases. PMS is considered "present" if the total scale score (220) on the PMS scale exceeds 50% (110).

    Measured: 3 month

  2. Eating Habits During the Premenstrual Period Form

    The form created by the researchers covering the change in food consumption during the PMS period consists of a total of 15 questions.Since there is no scale, there is no low or high score.

    Measured: 3 month

  3. Healthy Lifestyle Behaviors Scale

    The scale, which determines people's health-improving behaviors regarding their healthy lifestyle, consists of 48 items and 6 subgroups. The lowest total score of the scale, which has all positive items and 4 answer options, is 48 and the highest total score is 192.

    Measured: 3 month

  4. Emotional Eating Scale

    Emotional eating is defined as a coping strategy with negative emotions and experiences.The lowest score that can be obtained from the single-factor scale is 14 and the highest score is 70.

    Individuals who score 35 points and above from the scale are considered to have emotional eating.

    Measured: 3 month

  5. Perceived Stress Scale

    It shows how stressful the individual perceives the events he encounters.Scoring of the scale varies between 0 and 56, with a high score indicating that the individual has a high perception of stress.

    Measured: 3 month

  6. Visual comparison scale

    They were asked to question the existence of pain and to mark it on this scale by explaining the pain expressed by the points on it.The lowest score is 1 and the highest is 10, and as the score increases, the pain level increases.

    Measured: 3 month

  7. Personal Information Form

    The form prepared by the researchers consists of 3 sections and 46 questions.

    Measured: 3 month

Secondary outcomes (7)
  1. Feedback of the training using the Health Promotion Model and Philips 66 technique

    It will be filled out by the participants at the end of the training in the 8th week.

    Measured: 1 year

  2. Eating Habits During the Premenstrual Period Form

    The form will be filled out again in the 4th and 8th weeks of the study.The form created by the researchers covering the change in food consumption during the PMS period consists of a total of 15 questions.Since there is no scale, there is no low or high score.

    Measured: 1 year

  3. Premenstrual Syndrome Scale (PMSS)

    Participants in the study will be asked to fill out this scale in the 8th weeks. Women with premenstrual syndrome will be included in the study. The total score is obtained from the sum of the scores from all sub-dimensions. A minimum of 44 points and a maximum of 220 points can be obtained from the scale. An increase in the score obtained from the scale indicates that the intensity of the symptoms increases. PMS is considered "present" if the total scale score (220) on the PMS scale exceeds 50% (110).

    Measured: 1 year

  4. Healthy Lifestyle Behaviors Scale

    The scale will be applied at the 8th week. The scale, which determines people's health-improving behaviors regarding their healthy lifestyle, consists of 48 items and 6 subgroups. The lowest total score of the scale, which has all positive items and 4 answer options, is 48 and the highest total score is 192.

    Measured: 1 year

  5. Emotional Eating Scale

    The scale will be applied at the 8th week.Emotional eating is defined as a coping strategy with negative emotions and experiences.The lowest score that can be obtained from the single-factor scale is 14 and the highest score is 70. Individuals who score 35 points and above from the scale are considered to have emotional eating.

    Measured: 1 year

  6. Perceived Stress Scale

    The scale will be applied at the 8th week.It shows how stressful the individual perceives the events he encounters.Scoring of the scale varies between 0 and 56, with a high score indicating that the individual has a high perception of stress.

    Measured: 1 year

  7. Visual comparison scale

    The scale will be applied at the 8th week.They were asked to question the existence of pain and to mark it on this scale by explaining the pain expressed by the points on it.The lowest score is 1 and the highest is 10, and as the score increases, the pain level increases.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2023
  2. Study start30 Oct 2023
  3. Primary completion30 Nov 2023
  4. Study completion7 Oct 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The research will be conducted as a pretest-posttest randomized controlled study.
Masking
Single blind
Who is masked
Participant
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06105567
Sponsor's protocol ID
KAFKAS-SAG-CMAYDIN-002
Acronym
Premenstrual
Status last verified
Feb 2025
First submitted
16 Oct 2023
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aydin CM, Karabulutlu O. The effect of training provided according to the health promotion model on premenstrual symptoms, emotional eating behavior, and perceived stress. BMC Womens Health. 2026 May 12;26(1):336. doi: 10.1186/s12905-026-04538-4.

    PubMed 42121133

Questions about this trial

What is this clinical trial studying?

A study testing Training given according to the health promotion model by applying the Philips 66 technique in people with Premenstrual Syndrome and Emotional Disorder, run by Kafkas 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 8 inclusion and 8 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 10 Feb 2025. 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?

Premenstrual Syndrome Scale (PMSS) (time frame: 3 month). The study lists 7 primary outcomes in all. 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 NCT06105567, 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 10 Feb 2025.

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