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

Sponsor
Mersin University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05859399
Collaborator
(none)
58
2
7.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Laughter yoga
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, parallel, two arm, randomized controlled clinical trialProspective, parallel, two arm, randomized controlled clinical trial
Masking:
Single (Outcomes Assessor)
Masking Description:
Statistical analysis of the data will be done by an expert independent of the research.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Laughter Yoga on Premenstrual Symptoms and Quality of Life in Midwifery Students With Premenstrual Syndrome
Anticipated Study Start Date :
May 15, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental (laughter yoga) group

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.

Other: Laughter yoga
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.
Other Names:
  • Laughter therapy
  • No Intervention: Control group

    The control group will receive no intervention for 12 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Premenstrual Syndrome Scale (PMSS) [change from baseline, at the end of 12th week of intervention.]

      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

    1. World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) [change from baseline, at the end of 12th week of intervention.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mersin University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ahu AKSOY, Research Assistant, PhD, Mersin University
    ClinicalTrials.gov Identifier:
    NCT05859399
    Other Study ID Numbers:
    • 001
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 16, 2023
    Last Verified:
    May 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 Ahu AKSOY, Research Assistant, PhD, Mersin University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 16, 2023