The Effect of Laughter Therapy On The Food Craving

December 19, 2023 updated by: Sinop University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group

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.
Experimental: Experimental Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Premenstrual Syndrom Scale
Time Frame: One day
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.
One day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Food Craving:
Time Frame: 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.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinop University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meryem Erdoğan, PhD, Sinop University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • sınopUmeryem-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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