The Effect of Laughter Therapy On The Food Craving

Sponsor
Sinop University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05796869
Collaborator
(none)
100
1
2
4.9
20.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Assigned Interventions
N/A

Detailed 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 Diagnostic Scale total score of 43 and above will be included in the study. Since all women who have a Premenstrual Syndrome Diagnostic Scale of 43 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 Diagnostic Scale, and the Food Craving Scale will be administered again to both the application group and the control group.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Laughter Therapy On The Food Craving in Young Women With Premenstrual Syndrome
Anticipated Study Start Date :
Apr 3, 2023
Anticipated Primary Completion Date :
Jun 5, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

At the beginning of the study, data collection tools Personal Information Form, Premenstrual Syndrome Diagnostic 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.

Experimental: Experimental Group

All young women with a Premenstrual Syndrome Diagnostic Scale total score of 43 and above will be included in the study. Since all women who have a Premenstrual Syndrome Diagnostic Scale of 43 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 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 Diagnostic Scale, and the Food Craving Scale will be administered again to both the application group and the control group.

Behavioral: Assigned Interventions
Laughter therapy session 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. In the laughter therapy session, the practices of introducing the practitioner and introducing the therapy, breathing exercises for a healthy life, keeping the rhythm accompanied by music, turning the laughter that started as if it were childlike games into reality will be carried out.

Outcome Measures

Primary Outcome Measures

  1. Premenstrual Syndrom [One day]

    It was developed by Yıldırım Gürkan (2022) in accordance with DSM V criteria. The Premenstrual Symptoms Diagnostic Scale consists of 30 items and provides a 4-point Likert scale; It has five sub-dimensions: "Physical Status", "Cognitive Perception and Sleep Status", "Work and Social Life Status" and "Nutrition Status". There is no reverse coded expression in the measurement tool. The lowest 30 and the highest 120 points are obtained from the scale. Those who score between 30-42 are diagnosed as healthy, those with scores between 43-81 are diagnosed with PMS, and those with scores between 82-120 are diagnosed as PDD (Premenstrual Dysphroric Disorder).

Secondary Outcome Measures

  1. Food Craving: [One day]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sinop University Sinop Turkey 5700

Sponsors and Collaborators

  • Sinop University

Investigators

  • Principal Investigator: Meryem Erdoğan, PhD, Sinop University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sinop University
ClinicalTrials.gov Identifier:
NCT05796869
Other Study ID Numbers:
  • sınopUmeryem-1
First Posted:
Apr 4, 2023
Last Update Posted:
Apr 4, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sinop University

Study Results

No Results Posted as of Apr 4, 2023