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临床试验/NCT05831280
NCT05831280进行中(未招募)不适用

The Effect of Laughter Yoga on the Stress Levels of Infertility Women: A Randomized Controlled Trial

Ataturk University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
2
主要终点
Stress levels of women

研究概览

简要总结

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. Randomization was provided in the sample included in the study, and it was divided into experimental and control groups. At the beginning of the study, the Infertility Stress Scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks. No application was made to the control group. After 4 weeks, the Infertility Stress Scale was administered to the women in both groups to re-determine their stress levels.

详细描述

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. At the beginning of the study, necessary ethics committee permission and institutional permissions were obtained. Both of the researchers have a certificate of leadership in laughter yoga. As a result of the power analysis, it was determined that 80 women should be included in the study. Considering that there may be losses, it was decided to include 90 women in the study. By providing randomization, 90 women who met the sampling criteria and volunteered to participate in the study were divided into two groups as 45 experimental and 45 control. At the beginning of the study, the Infertility stress scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks, two sessions a week. No application was made to the control group. After 4 weeks, the Infertility stress scale was administered to the women in both groups to re-determine their stress levels.

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
Double (Participant, Outcomes Assessor)

盲法说明

The women in the experimental and control groups did not know which group they were in. Data were collected online due to the pandemic. Therefore, the researchers and the people who would conduct the analyzes did not know the women in the experimental and control groups. The women used a nickname to fill in the questions on the measurement tools.

入排标准

年龄范围
19 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • be between the ages of 19-45
  • have been diagnosed with infertility
  • At least primary school graduate
  • Not having a diagnosed psychiatric disease
  • Will not have an ovulation pick up process, Intrauterine insemination and Embryo transfer procedure in the next 1 month

排除标准

  • Have ovulation pick up process in the last 1 month
  • undergoing Intrauterine insemination in the last 1 month
  • undergoing an Embryo transfer in the last 1 month
  • Not regularly attending laughter yoga sessions (for the experimental group)
  • Applying another alternative method to reduce stress during the research process

结局指标

主要结局

Stress levels of women

时间窗: 1 month

The difference between the infertility stress scale pretest and posttest mean scores of women in both groups. Higher scores indicate increased stress.

次要结局

未报告次要终点

研究者

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

Aslı SİS ÇELİK

Associate Professor

Ataturk University

研究点 (2)

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