跳至主要内容
临床试验/NCT04355091
NCT04355091已完成不适用

Effect of Emotional Freedom Techniques (EFT) on Postpartum Depression

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
Change from baseline in Edinburgh Postpartum Depression Scale scores at 6 months

研究概览

简要总结

Hypothesis 1: Pregnant women in the EFT group will have a lower test score from Edinburgh Postpartum Depression Scale, and a follow-up score of three months and six months after the last application date, compared to the control group.

Hypothesis 2: In the post-test of pregnant women in the EFT group, three months and six months after the last application date, the optimistic, self-confident and social support approach methods used to deal with stress will increase, and the helpless and submissive approach styles will decrease compared to the control group.

Hypothesis 3: Pregnant women in the EFT group will have a lower test score from the State-Trait Anxiety Inventory, and a follow-up score of three months and six months after the last application date, compared to the control group.

详细描述

In addition to being a natural life event for women, pregnancy is also a period in which significant biological and psychosocial changes are experienced, and the risk of encountering many factors that may create anxiety and stress. While many women easily adapt to these changes occurring with pregnancy and childbirth, some women may develop various levels of mental illness. It is reported that the majority of depression, one of the mental illnesses, occurs in women aged 18-44, including fertility processes such as pregnancy, childbirth, and puerperium. A meta-analysis on the subject indicates that the rate of depression increases in pregnancy and postpartum period.

Depression during pregnancy can cause serious effects for all family members. Pregnancy depression which is not managed well, damages the developing fetüs due to problems such as poorly managed pregnancy depression, substance abuse, insufficient prenatal care, and suicide attempt. It also causes an increased level of cortisol, which can lead to insulin resistance and, if not compensated, gestational diabetes may occur. In this process, elevated norepinephrine and cortisol reduce blood flow to the uterus, causing very serious obstetric and neonatal consequences both on pregnant and fetus, and pregnancy-related adverse events such as HT and preeclampsia are also increasing. Postpartum depression is the most negative result of untreated depression during pregnancy.

In the initial treatment of pregnancy depression and postpartum depression, good psychosocial evaluation, activation of support systems and the combined use of integrated therapies are the most ideal options. Treatment options for postpartum depression are psychotherapy (interpersonal relationships therapy and cognitive - behavioral therapy), drug therapy and non-pharmacology applications. While it is recommended to apply psychotherapy and non-pharmacological approaches as the first choice in mild depression, the use of pharmacological treatments (antidepressants) stands out in moderate and severe depression.

One of the psychotherapeutic techniques, whose numbers have increased rapidly in recent years, is "Emotional Freedom Techniques (EFT)". EFT; It combines cognitive therapy, acceptance and stability therapy, and acupuncture point stimulation, and is based on manual stimulation of acupuncture points specific to Shiatsu or other acupressure massage forms, rather than using acupuncture needles.Manual pressure on acupuncture sites has been found to be as effective as acupuncture needling technique.It is an initiative that can be applied by individuals and midwives easily after receiving the necessary education all over the world.

EFT has a comprehensive research bibliography that includes successful treatment of various psychological conditions such as depression, anxiety, phobias, and post-traumatic stress disorder. The duration of treatment in these studies varies from one to ten sessions. Feinstein states that in EFT studies that include a follow-up assessment, participants maintain their profit and the rehabilitation period varies between 3 months and 2 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • To be in the 18-49 age range
  • To be at least a primary school graduate
  • To be pregnant between 13-30 weeks
  • Not having a risky pregnancy,
  • Having spontaneous pregnancy,
  • Having a single and live fetus
  • Not having a chronic serious physical illness or disability
  • The absence of infection, wound, scar in the tapping area

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in Edinburgh Postpartum Depression Scale scores at 6 months

时间窗: Baseline and 6 months

The scale consists of 10 items. Items are evaluated in 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0, the highest score is 30. Each item is scored as 0,1,2,3 in the scale. In the evaluation of 3,5,6,7,8,9,10 items, the scoring is reversed (3,2,1,0). Individuals with a total scale score higher than the cut-off point are considered a risk group for depression. The cut-off score was taken as 12 in this study.

次要结局

  • State-Trait Anxiety Inventory(Change from baseline in State-Trait Anxiety scores at 6 months)
  • Stress Coping Styles Scale(Change from baseline in stress coping styles at 6 months)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Neriman Guducu

Research Assistant

Istanbul University - Cerrahpasa

研究点 (2)

Loading locations...

相似试验