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临床试验/NCT07449013
NCT07449013已完成不适用

The Effect Of Laughter Yoga and Emotional Freedom Technique on Anxiety in Pregnant Women: A Randomized Controlled Trial

Kırklareli University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
State-Trait Anxiety Inventory (STAI) scale

研究概览

简要总结

This research was designed as a randomized controlled experimental study to determine the effects of laughter yoga and emotional freedom techniques(EFT) on anxiety in pregnant women.

详细描述

Pregnancy is a process that involves not only physical changes to the body but also profound and continuous emotional and psychological changes. Hormonal fluctuations, bodily changes, cultural norms, and the responsibilities that come with motherhood can cause anxiety in pregnant women. A systematic review and meta-analysis conducted to determine anxiety experienced during pregnancy found that the prevalence of anxiety was 22%. In a study conducted in Turkey, it was reported that 32% of pregnant women experienced anxiety during pregnancy. When looking at the effects of anxiety during pregnancy on the mother and baby, it is seen that there are many negative effects, ranging from low birth weight to an increased risk of postpartum depression. Therefore, methods for coping with anxiety become important at this point.

Laughter yoga and the emotional freedom technique(EFT) are effective methods for reducing anxiety. Laughter yoga is an exercise programme that combines unconditional laughter with yoga breathing (Pranayama) techniques. It lowers stress hormone levels and stimulates the release of endorphins, making the person feel good. The emotional freedom technique is an energy technique based on the idea that 'the source of negative emotions is disturbances in the body's energy system.' It provides relaxation by balancing the person's energy fields. A review of the literature reveals that no studies have been conducted on the effects of laughter yoga and the emotional freedom technique on anxiety during pregnancy.This research was planned to determine the effect of laughter yoga and the emotional freedom technique applied to pregnant women on anxiety.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • For the laughter yoga group: Pregnant women who are willing to participate in the study, can read and understand Turkish, are aged 18 or over, have scored 37 or above on the STAI, have a spontaneous pregnancy, are in their second or third trimester, and have not previously practised laughter yoga.
  • For the emotional freedom technique(EFT) group: Pregnant women who are willing to participate in the study, can read and understand Turkish, are aged 18 or over, have scored 37 or above on the STAI, have a spontaneous pregnancy, are in their second or third trimester, have not previously undergone EFT, and have no infections, wounds, scars, etc. in the tapping areas where EFT will be applied.
  • For the control group: Pregnant women who volunteered to participate in the study, can read and understand Turkish, are aged 18 or over, scored 37 or above on the STAI, have a spontaneous pregnancy, are in their second or third trimester, and have not previously practised laughter yoga or EFT.

排除标准

  • For the laughter yoga group: Those wishing to continue working, those diagnosed with a high-risk pregnancy, those with chronic illnesses (hypertension, diabetes, thyroid disorders, etc.), those with psychiatric illnesses and/or undergoing psychiatric treatment (pharmacotherapy or psychotherapy), those with any issues that prevent communication (such as impaired hearing, speech, or comprehension), those using pharmacological or non-pharmacological methods to reduce anxiety, those who have undergone abdominal surgery in the last three months, and pregnant women with glaucoma, hernia, epilepsy, bleeding haemorrhoids, or heart disease.
  • For the EFT and control group: Those who do not wish to continue the study, those diagnosed with a high-risk pregnancy, those with chronic illnesses (hypertension, diabetes, thyroid disorders, etc.), Those with psychiatric disorders and/or undergoing psychiatric treatment (pharmacotherapy or psychotherapy), Those with any condition that impedes communication (such as impaired hearing, speech, or comprehension), Pregnant women using either pharmacological or non-pharmacological methods to reduce anxiety.

研究组 & 干预措施

Emotional freedom technique(EFT) group

Experimental

Emotional freedom technique will be applied to pregnant women with anxiety during pregnancy.

干预措施: Emotional freedom technique (Other)

Laughter yoga group

Experimental

Laughter yoga will be applied to pregnant women with anxiety during pregnancy.

干预措施: Laughter yoga (Other)

Control group

No Intervention

Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms.

结局指标

主要结局

State-Trait Anxiety Inventory (STAI) scale

时间窗: between six to twelve months

This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.

Introductory Information Form

时间窗: between six to twelve months

A form that includes questions about women's socio-demographic and pregnancy and characteristics.

Pregnancy-related anxiety scale(PrAS)

时间窗: between six to twelve months

This scale was originally developed by Brunton, and its Turkish validity and reliability were established by Solt and Gul. It is used to evaluate pregnancy-related anxiety. Higher total scores, as well as higher scores across its nine subscales, indicate greater levels of anxiety in pregnant women.It will be used to assess pregnancy-related anxiety.

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

Efsun Derin

Principal Investigator

Kırklareli University

研究点 (1)

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