The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality

NCT ID: NCT05859594

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vasomotor; Syndrome Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, two arm, randomized controlled clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Statistical analysis of the data will be done by an expert independent of the research.

Study Groups

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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.

Group Type EXPERIMENTAL

Laughter yoga

Intervention Type OTHER

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.

Control group

The control group will receive no intervention for 4 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Laughter therapy

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Ahu AKSOY

Research Assistant, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahu Aksoy Can, PhD

Role: PRINCIPAL_INVESTIGATOR

Mersin University Nursing Faculty

Locations

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Mersin University

Yenişehir, Mersin, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9477613/pdf/main.pdf

The effect of online laughter therapy on depression, anxiety, stress, and loneliness among nursing students during the Covid-19 pandemic

Other Identifiers

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246

Identifier Type: -

Identifier Source: org_study_id

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