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

May 15, 2023 updated by: Ahu AKSOY, Mersin University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

58

Phase

  • 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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premenstrual Syndrome Scale (PMSS)
Time Frame: 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
change from baseline, at the end of 12th week of intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)
Time Frame: 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.
change from baseline, at the end of 12th week of intervention.

Collaborators and Investigators

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

Sponsor

Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Anticipated)

May 15, 2023

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES))

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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