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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05859399
Other study ID # 001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2023
Est. completion date December 31, 2023

Study information

Verified date May 2023
Source Mersin University
Contact Ahu AKSOY CAN, PhD
Phone 05444825892
Email aksoyahu91@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 58
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 change from baseline, at the end of 12th week of intervention.
Secondary 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. change from baseline, at the end of 12th week of intervention.
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