An interventional study of Assigned Interventions in PMS, LAUGHTER and Food Habits, sponsored by Sinop University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by Sinop University · Not applicable, Interventional, and Supportive care
Premenstrual syndrome (PMS) is characterized by physical, emotional, and behavioral symptoms in the luteal phase that significantly disrupt women's daily lives, including work and personal activities, and resolve spontaneously within a few days of the onset of menstruation. The premenstrual syndrome causes emotional eating, excessive consumption of certain foods, and increased appetite. These unhealthy eating patterns in eating behavior affect health negatively. Women with PMS have an increased appetite and food cravings. It has been stated that the increase in appetite and food cravings are reduced by laughter therapy. Thus, the laughter therapy method, which has no side effects in PMS and negative eating behaviors, can be used and recommended or applied by health professionals.
The universe of the research will be all young women with PMS who study at the designated Faculty of Health Sciences in the Spring semester of the 2022-2023 academic year. The sample of the study will be all young women studying at the Faculty of Health Sciences, meeting the inclusion criteria and agreeing to participate in the study. All young women with a Premenstrual Syndrome Scale total score of 110 and above will be included in the study. Since all women who have a Premenstrual Syndrome Diagnostic Scale of 110 and above, volunteer to participate in the study, and meet the inclusion criteria will be included in the study, no additional sample selection will be made. The application and control group will be determined on random.org among the group that constitutes the sample of the study. Laughter therapy sessions will be applied online for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. At the end of two months, the Personal Information Form, Premenstrual Syndrome Scale, and the Food Craving Scale will be administered again to both the application group and the control group.
Sinop University is the lead sponsor of 30 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
At the beginning of the study, data collection tools Personal Information Form, Premenstrual Syndrome Scale and Food Craving Scale will be applied to the control group. No intervention will be made in the control group. Measurement tools will be applied for the post-test.
All young women with a Premenstrual Syndrome Scale total score of 110 and above will be included in the study. Since all women who have a Premenstrual Syndrome Diagnostic Scale of 110 and above, volunteer to participate in the study and meet the inclusion criteria will be included in the study, no additional sample selection will be made. The application and control group will be determined on random.org among the group that constitutes the sample of the study. Laughter therapy sessions will be administered face to face to the application group once a week for 2 months by a researcher with a laughter therapy certificate. At the end of two months, the Personal Information Form, Premenstrual Syndrome Scale, and the Food Craving Scale will be administered again to both the application group and the control group.
Behavioral: Assigned Interventions
The laughter therapy session will be administered to the application group face to face for 25-30 minutes once a week for 2 months by a researcher with a laughter therapy certificate. In the laughter therapy session, introducing the practitioner and introducing the therapy, breathing exercises for a healthy life, maintaining the rhythm with music, turning laughter that starts like a child's play into reality and meditation practices will be carried out.
Premenstrual Syndrom Scale
It is a scale developed by Gençdoğan in 2006, measuring the severity of premenstrual symptoms, with a five-point Likert type, containing 44 items and consisting of nine subscales: Depressive Affectiveness, Anxiety, Fatigue, Nervousness, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes and Bloating. When scoring on the scale, "Always" is scored as 5 points, "Often" as 4 points, "Sometimes" as 3 points, "Very little" as 2 points and "Never" as 1 point, and it is evaluated over the total score. The application of the scale is done by retrospectively evaluating the person's "being in the week before menstrual bleeding" situation. The lowest score from the scale is 44 and the highest score is 220. The higher the score, the more severe PMS symptoms are considered. If the person exceeds 50% (110) of the total scale score (220) on the PMS scale, PMS is considered to be present. In the reliability study of the scale, Cronbach's Alpha value was found to be 0.75.
Time frame: One day
Food Craving:
The scale was developed by Cepeda-Benito et al. (2000) Akkurt et al. (2019) Turkish validity and reliability were performed. The scale consists of 39 items and is evaluated in a 6-point Likert type. The scale has 9 sub-dimensions. Sub-dimensions and items in sub-dimensions are as follows. "Having Intentions and Plans to Consume Food", "Anticipation of Positive Reinforcement Feelings As a Result of Eating", "Lack of Eating Control Over Eating", "Thoughts or Preoccupation with Food Cravings or Eating", "Craving as a Physiological State", "Emotions That May Be Experienced Before or During Meal", "Cues That May Trigger Food Craving", "Guilt From Cravings and/or for Giving Into Them". The score of each sub-dimension and scale is obtained by dividing the total item scores by the number of items. The scores obtained in this way express the high desire to eat in the scale and in the sub-dimensions.
Time frame: One day
Plan to share: No
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