NCT06105567

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2024

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

October 16, 2023

Last Update Submit

February 6, 2025

Conditions

Keywords

premenstrual syndromeemotional eatinghealth promotion model

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Personal Information Form

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

    3 month

Secondary Outcomes (7)

  • Feedback of the training using the Health Promotion Model and Philips 66 technique

    1 year

  • Eating Habits During the Premenstrual Period Form

    1 year

  • Premenstrual Syndrome Scale (PMSS)

    1 year

  • Healthy Lifestyle Behaviors Scale

    1 year

  • Emotional Eating Scale

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Effect of Education on Premenstrual Symptoms, Emotional Eating Behavior and Perceived Stress

EXPERIMENTAL

Students 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.

Behavioral: Training given according to the health promotion model by applying the Philips 66 technique

control group

NO INTERVENTION

Students 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.

Interventions

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

Also known as: control group, health promotion model, Philips 66 technique
Effect of Education on Premenstrual Symptoms, Emotional Eating Behavior and Perceived Stress

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspremenstrual syndrome
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • st and 4th year nursing and midwifery students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafkas University

Kars, Kars, 36100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual SyndromeEmotional Eating

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The research will be conducted as a pretest-posttest randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 27, 2023

Study Start

October 30, 2023

Primary Completion

November 30, 2023

Study Completion

October 7, 2024

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations