Premenstrual Syndrome Clinical Trial
— PremenstrualOfficial title:
The Effect of Education Given According to the Health Promotion Model on Premenstrual Symptoms, Emotional Eating Behavior and Perceived Stress
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Kafkas University | Kars |
Lead Sponsor | Collaborator |
---|---|
Kafkas University |
Turkey,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02481973 -
The Effect of Individualised Homoeopathic Treatment Using the Grant Bentley Method in Premenstrual Syndrome
|
Phase 2 | |
Completed |
NCT00195559 -
Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
|
Phase 3 | |
Completed |
NCT00048854 -
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
|
Phase 1/Phase 2 | |
Completed |
NCT00965562 -
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
|
N/A | |
Completed |
NCT05349344 -
Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS).
|
N/A | |
Recruiting |
NCT06146673 -
A Multidimensional Study of Premenstrual Syndrome and Body Image
|
||
Recruiting |
NCT05836454 -
The Soft Tissue Mobilization Techniques on PMS
|
N/A | |
Completed |
NCT05499000 -
The Effect of Emotional Freedom Technique on Premenstrual Syndrome
|
N/A | |
Recruiting |
NCT06144073 -
The Effect of Mandala Art Therapy in Coping With Premenstrual Syndrome
|
N/A | |
Completed |
NCT03298607 -
The Impact of Serelys PMS on Symptoms of PMS
|
Phase 3 | |
Recruiting |
NCT06176313 -
Effects of Training Given to Cope With Premenstrual Syndrome and Mandala Activity on Premenstrual Symptoms
|
N/A | |
Recruiting |
NCT02562053 -
Does Adding Oral Contraceptives to Fluoxetine Improve the Management of Premenstrual Syndrome?
|
Phase 3 | |
Completed |
NCT00229346 -
Fibromyalgia and Psychiatric Symptoms Among PMS and PMDD Patients
|
N/A | |
Completed |
NCT00516113 -
A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria
|
Phase 4 | |
Completed |
NCT04901598 -
Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome
|
||
Completed |
NCT05692479 -
Premenstrual Syndrome and Physical Activity Self-Worth
|
||
Completed |
NCT05665972 -
Effects of Mandala Coloring on Premenstrual Syndrome
|
N/A | |
Not yet recruiting |
NCT06052722 -
The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders
|
N/A | |
Completed |
NCT05556252 -
The Effect of Hydrogen-rich Water on Premenstrual Symptoms and Quality of Life
|
N/A | |
Completed |
NCT05725447 -
Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)
|