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临床试验/NCT05345067
NCT05345067已完成不适用

The Effect of Laughter Yoga on the Anxiety and Stress Levels of Women in the Postpartum Period: A Randomized Controlled Trial

Ataturk University2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2022年1月1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
144
试验地点
2
主要终点
Questionnaire Form

研究概览

简要总结

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the anxiety and stress levels of postpartum 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 Postpartum anxiety scale and the perceived stress scale were applied to women in both groups to determine their anxiety and 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 Postpartum anxiety scale and the perceived stress scale were administered to the women in both groups to re-determine their anxiety and stress levels.

详细描述

This research is a randomized controlled study to evaluate the effect of Laughter yoga on the anxiety and stress levels of postpartum 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 128 women should be included in the study. Considering that there may be losses, it was decided to include 160 women in the study. By providing randomization, 160 women who met the sampling criteria and volunteered to participate in the study were divided into two groups as 80 experimental and 80 control. At the beginning of the study, the Postpartum anxiety scale and the perceived stress scale were applied to women in both groups to determine their anxiety and 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 Postpartum anxiety scale and the perceived stress scale were administered to the women in both groups to re-determine their anxiety and stress levels. In the study, 7 women from the experimental group and 9 women from the control group were excluded for various reasons. The study was conducted with 73 experimental and 71 control groups. The process of making analyzes and writing the final report continues. This study is financially supported by Atatürk University Scientific Research Coordination Unit. In addition, this study is carried out as a master's thesis accepted by Atatürk University Health Sciences Institute.

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
  • Giving birth by vaginal / Caesarean section
  • 1 month after birth
  • Having a healthy baby
  • Not experiencing any complications during birth and postpartum
  • At least primary school graduate
  • Not having a diagnosed psychiatric disease

排除标准

  • Having a medical condition (hypertension, wound complication, etc.)
  • Not regularly attending laughter yoga sessions (for the experimental group)
  • Applying another alternative method to reduce anxiety and stress in the postpartum period

结局指标

主要结局

Questionnaire Form

时间窗: up to 2 weeks

Prepared by the researcher; There are introductory information such as age, education level, family type and 24 questions about the postpartum period. This form determines the introductory characteristics of the participants. therefore no points are taken.

Postpartum Specific Anxiety Scale

时间窗: up to 2 weeks

This scale was developed by Fallon et al. to evaluate postpartum anxiety symptoms. The Turkish adaptation of the scale was made by Duran in 2019. Since it was determined that some items could be in different groups in the adaptation to Turkish, it was decided to be one-dimensional and some items not to be in the Turkish version. The Turkish form of the scale was evaluated as one-dimensional and 47 items. It can be said that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level of anxiety.

Perceived Stress Scale

时间窗: up to 2 weeks

It was developed by Cohen, Kamarck \& Mermelste in 1983 to measure the perceived stress of a person in any situation, and was adapted into Turkish by Eskin et al. It contains 14 items in total. Participants evaluated the items on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". 7 items containing positive statements are scored in reverse. Scoring ranges from 0 to 56, while a high score indicates that the person is highly stressed.

次要结局

  • Postpartum Specific Anxiety Scale(up to 3 weeks)
  • Perceived Stress Scale(up to 3 weeks)

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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