Clinical trial NCT04355091: Emotional Freedom Techniques (EFT) and Postpartum Depression
Official title: Effect of Emotional Freedom Techniques (EFT) on Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: postpartum depression
pregnancy
stress
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In order to determine the risk of depression, the Edinburgh Postpartum Depression Scale (EPDS) will be administered to the pregnant women. Pregnant women who receive 12 ≥ points from the EPDS will be included in the randomization process.

Subsequently, the tests will be applied to experimental and control groups. EFT will be applied to women in the experimental group. One or two weeks after the application, it will be discussed again and questioned how she feels, whether that problem still disturbs her. The number of EFT sessions can be increased or decreased depending on the condition of the woman (the average number of sessions reported in the studies ranges from 2-10). After all EFT sessions are completed, three months and six months after the last application, post-tests will be done. the control group will receive routine midwifery care. The post-tests will be done by the control group after three months and six months
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Considering all these data, it is necessary to focus primarily on the prenatal period in order to develop preventive and therapeutic interventions. In the literature, scientific studies evaluating the effectiveness of EFT on depression are included, but only one study has been reached in which EFT is applied during pregnancy, and this study is related to stress and endurance. In addition, with this study, an important step will be taken to include an easy-to-apply, inexpensive therapeutic method such as pregnancy and postpartum depression treatments, and evidence will be sought to ensure that all professionals dealing with women's health, especially midwifery, use this technique.

The aim of the study is to evaluate the effect of EFT on postpartum depression.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-

Primary outcomes:
measure: Change from baseline in Edinburgh Postpartum Depression Scale scores at 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Stress Coping Styles Scale
timeFrame: Change from baseline in stress coping styles at 6 months
measure: State-Trait Anxiety Inventory
timeFrame: Change from baseline in State-Trait Anxiety scores at 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpaşa
state: Eyalet/Yerleşke
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Neslihan Ozcan, Professor
role: STUDY_DIRECTOR
References: