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Completed

NCT Number: NCT05859594

The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality

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.

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Key information

Conditions

Vasomotor; Syndrome Disease Dyssomnias Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Syndrome

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University

Yenişehir, Mersin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laughter yoga

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.

Other names: Laughter therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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".

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 16, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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