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

Premenstrual Syndrome Clinical Trial

— Premenstrual  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105567
• Other study ID #: KAFKAS-SAG-CMAYDIN-002
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Kafkas University
• Contact: cansu M aydin, research assistant
• Phone: 05529402140
• Email: cansumine2236[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• • 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

Related Conditions & MeSH terms

• Emotional Disorder
• Perceived Stress
• Premenstrual Syndrome

Intervention

Behavioral:
• Training given according to the health promotion model by applying the Philips 66 technique
The Effect of Education Given According to the Health Promotion Model on Premenstrual Symptoms, Emotional Eating Behavior and Perceived Stress

Locations

Country	Name	City	State
Turkey	Kafkas University	Kars

Sponsors (1)

Lead Sponsor	Collaborator
Kafkas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3 month
Primary	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.	3 month
Primary	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.	3 month
Primary	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.	3 month
Primary	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.	3 month
Primary	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.	3 month
Primary	Personal Information Form	The form prepared by the researchers consists of 3 sections and 46 questions.	3 month
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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).	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year