NCT05796869

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

March 21, 2023

Last Update Submit

December 19, 2023

Conditions

Keywords

PMSLaughter TherapyYoung womenFood Craving

Outcome Measures

Primary Outcomes (1)

  • 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.

    One day

Secondary Outcomes (1)

  • Food Craving:

    One day

Study Arms (2)

Control Group

NO INTERVENTION

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 Group

EXPERIMENTAL

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

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.

Experimental Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHaving a PMS score of 43 and above
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop University

Sinop, 5700, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

LaughterFeeding Behavior

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehaviorBehavior, Animal

Study Officials

  • Meryem Erdoğan, PhD

    Sinop University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meryem Erdoğan, PhD

CONTACT

Adeviye Aydın, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 4, 2023

Study Start

November 20, 2023

Primary Completion

January 20, 2024

Study Completion

January 30, 2024

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations