The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality

Sponsor

Mersin University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05859594

Collaborator

(none)

Enrollment

Arms

5.7

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vasomotor; Syndrome Sleep	Other: Laughter yoga	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, parallel, two arm, randomized controlled clinical trialProspective, parallel, two arm, randomized controlled clinical trial

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Supportive Care

Official Title:

The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality in Menopausal Women

Anticipated Study Start Date :

May 9, 2023

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

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.	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 4 weeks.

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.

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 4 weeks.

Outcome Measures

Primary Outcome Measures

Visual Analog Scala (VAS) [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.

Secondary Outcome Measures

Sleep quality [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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