The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality
September 7, 2023 updated by: Ahu AKSOY, Mersin University
The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality in Menopausal Women
The research was planned as a prospective, randomized controlled experimental study to determine the effect of online laughter yoga applied to menopausal women on vasomotor symptoms (VMS) and sleep quality.
Research Hypotheses ar below; H0: Online laughter yoga has no effect on VMS.
H1: Online laughter yoga has an effect on VMS.
H0: Online laughter yoga has no effect on sleep quality.
H1: Online laughter yoga has an effect on sleep quality.
Study Overview
Detailed Description
The sample will consist of 82 menopausal women aged 40-60 years and experiencing at least one of the VMS. Intervention group: Online laughter yoga will be applied to women by a researcher who has an internationally approved certificate. The intervention group will receive eight online laughter yoga sessions, two sessions per week for four 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.
No intervention will be applied to the control group.
Study Type
Interventional
Enrollment (Actual)
36
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 Locations
-
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Mersin
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Yenişehir, Mersin, Turkey
- Mersin University
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-
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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- - enrolled in the Menopause School,
- Signing the Informed Consent Form,
- Willing to participate in the research,
- Able to read and write Turkish,
- Open to communication,
- Those who are between the ages of 40-60 and have not experienced menstruation for at least one year,
- Experiencing at least one of the vasomotor symptoms
- A VMS severity of at least 4 according to the Visual Analog Scale,
- Not using drugs for the treatment of vasomotor symptoms,
- No chronic disease
- Regular laughter yoga is not practiced,
- Those who have not entered the menopause surgically,
- Women without psychiatric problems
Exclusion Criteria:
- - Not enrolled in Menopause School,
- Not signing the Informed Consent Form,
- Not willing to participate in the research,
- Cannot read and write Turkish,
- Unable to communicate
- Less than 40 years old, over 60 years old, experienced menstruation for at least one year,
- Not experiencing vasomotor symptoms,
- VMS severity is less than 4 according to the Visual Analog Scale,
- Using drugs for the treatment of vasomotor symptoms,
- Having a chronic disease,
- Regular laughter yoga practice
- Those who have surgically entered the menopause,
- Women with psychiatric problems
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 eight online laughter yoga sessions, two sessions per week for four 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.
|
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:
|
|
No Intervention: Control group
The control group will receive no intervention for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scala (VAS)
Time Frame: change from baseline, at the end of 4th week of intervention.
|
The Visual Analog Scale is used to measure the pain perceived by the person.
There is a 10 cm mark on the one end of the scale, where there is no pain (zero), and on the other end there is the most severe (10) pain.
Between the (100 mm.) part, the individual can indicate his or her pain by drawing a line, putting a dot or pointing.
The distance from the point where there is no pain to the point marked by the individual is measured in centimeters, and the value found indicates the severity of the individual's pain.
In this study, VAS will be used for hot flashes, night sweats and sweating experienced by women.
Women will indicate where their situation is appropriate on this line by drawing a line or by placing a dot/mark.
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change from baseline, at the end of 4th week of intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality
Time Frame: change from baseline, at the end of 4th week of intervention.
|
The Pittsburgh Sleep Quality Index (PUKI) will be used to assess sleep quality.
PUKI sleep quality; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction.
Those with a total score above five on the PUKI are considered "poor", and those with a score of five or below are considered "good".
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change from baseline, at the end of 4th week of intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahu Aksoy Can, PhD, Mersin University Nursing Faculty
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.
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 (Actual)
May 2, 2023
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
August 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)
September 8, 2023
Last Update Submitted That Met QC Criteria
September 7, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 246
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
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