Clinical trial NCT05859594: The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality
Official title: The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality in Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasomotor; Syndrome
Sleep
Keywords: vasomotor symptoms
sleep quality
menopause
laughter yoga
laughter therapy
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 36
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scala (VAS)
timeFrame: change from baseline, at the end of 4th week of intervention.
Secondary outcomes:
measure: Sleep quality
timeFrame: change from baseline, at the end of 4th week of intervention.
Other outcomes:
Locations:
city: Yenişehir
country: Turkey
facility: Mersin University
state: Mersin
Study officials:
affiliation: Mersin University Nursing Faculty
name: Ahu Aksoy Can, PhD
role: PRINCIPAL_INVESTIGATOR
References: