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The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students

Primary Purpose

Premenstrual Syndrome, Quality of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laughter yoga
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring Premenstrual Syndrome, Quality of life, Laughter yoga, Laughter therapy, Student

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: To agree to participate in the research, To be over 18 years old, Not having taken vocational courses Not having a chronic disease, Having a regular menstrual period, Having at least 110 points on the PMS scale Not receiving medical treatment for PMS. Exclusion Criteria: Refusing to participate in the research, To have taken vocational courses, Having a chronic illness Getting a score lower than 110 on the PMS scale, Having any condition where laughter yoga should be avoided (having had abdominal surgery in the last three months, taking regular medications, epilepsy, uncontrollable hypertension, glaucoma, hernia, etc.) Receiving medical treatment for PMS.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental (laughter yoga) group

    Control group

    Arm Description

    The intervention group will receive 12 online laughter yoga sessions, only one session per week for 12 weeks. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.

    The control group will receive no intervention for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Premenstrual Syndrome Scale (PMSS)
    The Premenstrual Syndrome Scale is a five-point Likert type scale consisting of 44 questions that measures the severity of premenstrual symptoms, based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms

    Secondary Outcome Measures

    World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)
    Life of quality will be evaluated by using the WHOQOL-BREF-TR. This scale consists of 27 questions. There are a total of five areas in the scale: physical, mental, social, environmental and national environmental areas. Each area is evaluated within itself. The domain score is calculated with the score it gets from the questions that determine it. Field scores are evaluated between 4-20. Increasing score indicates goodness.

    Full Information

    First Posted
    May 5, 2023
    Last Updated
    May 15, 2023
    Sponsor
    Mersin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05859399
    Brief Title
    The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students
    Official Title
    The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students With Premenstrual Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mersin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The research was planned as a prospective, randomized controlled experimental study to determine the effect of laughter yoga applied to midwifery students on premenstrual symptoms (PMS) and quality of life. Research Hypotheses H0: Online laughter yoga has no effect on premenstrual symptoms. H1: Online laughter yoga has an effect on premenstrual symptoms. H0: Online laughter yoga has no effect on quality of life. H1: Online laughter yoga has an impact on quality of life.
    Detailed Description
    59 midwifery students will participate in the research. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premenstrual Syndrome, Quality of Life
    Keywords
    Premenstrual Syndrome, Quality of life, Laughter yoga, Laughter therapy, Student

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, parallel, two arm, randomized controlled clinical trial
    Masking
    Outcomes Assessor
    Masking Description
    Statistical analysis of the data will be done by an expert independent of the research.
    Allocation
    Randomized
    Enrollment
    58 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental (laughter yoga) group
    Arm Type
    Experimental
    Arm Description
    The intervention group will receive 12 online laughter yoga sessions, only one session per week for 12 weeks. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The control group will receive no intervention for 12 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Laughter yoga
    Other Intervention Name(s)
    Laughter therapy
    Intervention Description
    Although the history of laughter yoga dates back to ancient times, its use in medicine has become widespread in the 21st century, while it is used to reduce pain, anxiety, stress, depression and fatigue, it is also a method that can be used to accelerate immunity, quality of life, happiness, sleep quality and recovery.
    Primary Outcome Measure Information:
    Title
    Premenstrual Syndrome Scale (PMSS)
    Description
    The Premenstrual Syndrome Scale is a five-point Likert type scale consisting of 44 questions that measures the severity of premenstrual symptoms, based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms
    Time Frame
    change from baseline, at the end of 12th week of intervention.
    Secondary Outcome Measure Information:
    Title
    World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)
    Description
    Life of quality will be evaluated by using the WHOQOL-BREF-TR. This scale consists of 27 questions. There are a total of five areas in the scale: physical, mental, social, environmental and national environmental areas. Each area is evaluated within itself. The domain score is calculated with the score it gets from the questions that determine it. Field scores are evaluated between 4-20. Increasing score indicates goodness.
    Time Frame
    change from baseline, at the end of 12th week of intervention.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: To agree to participate in the research, To be over 18 years old, Not having taken vocational courses Not having a chronic disease, Having a regular menstrual period, Having at least 110 points on the PMS scale Not receiving medical treatment for PMS. Exclusion Criteria: Refusing to participate in the research, To have taken vocational courses, Having a chronic illness Getting a score lower than 110 on the PMS scale, Having any condition where laughter yoga should be avoided (having had abdominal surgery in the last three months, taking regular medications, epilepsy, uncontrollable hypertension, glaucoma, hernia, etc.) Receiving medical treatment for PMS.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahu AKSOY CAN, PhD
    Phone
    05444825892
    Email
    aksoyahu91@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9477613/pdf/main.pdf
    Description
    The effect of online laughter therapy on depression, anxiety, stress, and loneliness among nursing students during the Covid-19 pandemic

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    The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students

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