The Effect of Laughter Therapy On The Food Craving

Food Habits Clinical Trial

Official title:

The Effect of Laughter Therapy On The Food Craving in Young Women With Premenstrual Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796869
• Other study ID #: sinopUmeryem-1
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: December 2023
• Source: Sinop University
• Contact: Meryem Erdogan, PhD
• Phone: +905364959633
• Email: meryemerdogan84[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 30, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Being a nursing student,
• Being a female student,
• Volunteering to participate in the study.
• Having a PMS score of 43 and above

Exclusion Criteria:

• Not to study as a nursing student
• Being a male student
• Not to volunteer to participate in the study
• Participants who have a PMS score of 42 and below

Related Conditions & MeSH terms

• Food Habits
• PMS

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sinop University	Sinop

Sponsors (1)

Lead Sponsor	Collaborator
Sinop University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premenstrual Syndrom Scale	It is a scale developed by Gençdogan 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.	One day
Secondary	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.	One day