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临床试验/NCT05859594
NCT05859594已完成不适用

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

Mersin University2 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2023年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Visual Analog Scala (VAS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • - 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

排除标准

  • - 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

结局指标

主要结局

Visual Analog Scala (VAS)

时间窗: 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.

次要结局

  • Sleep quality(change from baseline, at the end of 4th week of intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahu AKSOY

Research Assistant, PhD

Mersin University

研究点 (2)

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