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Emotional Freedom Techniques (EFT) and Postpartum Depression

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Emotional Freedom Techniques (EFT)
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring postpartum depression, pregnancy, stress

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Istanbul University Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

control group

Arm Description

The pregnant women in this group will be informed about the application of EFT with a written material. The pregnant women who have undergone EFT will be interviewed a week or two after the application, and how they feel and whether the problem still disturbs him. If a new issue is reported, similar actions will be repeated for this new issue. The number of EFT sessions was decided based on the condition of the pregnant woman. After all EFT sessions are completed, a re-evaluation (post-test) of Edinburgh Postpartum Depression Scale, Stress Coping Scale and State-Trait Anxiety Inventory will be done. The same participants will be asked to apply the other inventories and the postpartum interview form if she had birth three months and six months after the last application (follow-up). In the follow-up study performed three months after the last application, EFT will be applied to the pregnant women in need.

The participants in this group will be talked about the problems they should have in routine midwifery care, the problems they encounter during pregnancy or postpartum period and the subjects they want to receive information. If necessary, suggestions will be made for problems related to pregnancy, postpartum period or newborn care. Again, with these participants, after the depression risk determination (pre-test), after the interviews ended (post-test), three months and six months after the last application, Edinburgh Postpar All Depression Scale, Stressful Life Events List, Stress Coping Scale. If the pregnant woman has given birth, State-Trait Anxiety Inventory and postnatal interview form will be performed.

Outcomes

Primary Outcome Measures

Change from baseline in Edinburgh Postpartum Depression Scale scores at 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.

Secondary Outcome Measures

Stress Coping Styles Scale
This scale is used to determine the coping mechanisms used by the participants in the face of stressful situations.It consists of 30 items and 5 sub-dimensions. High scores from each of the five subscales identified indicate an increase in the use of coping style expressed by that subscale. These subscales and the items are as follows: Self-Confident Approach: 8, 10, 14, 16, 20, 23, 26, Optimistic Approach: 2, 4, 6, 12 18,, Helpless Approach: 3, 7, 11, 19, 22, 25, 27, 28, Submissive Approach: 5, 13, 15, 17, 21, 24, Contacting Social Support: 1, 9, 29, 30. Items 1 and 9 in the scale are reversed. Subgroup scores are obtained by dividing the score from each sub-dimension by the number of items.
State-Trait Anxiety Inventory
This scale consists of a total of forty items; the "State Anxiety Scale" consisting of twenty items and the "Trait Anxiety Scale" consisting of twenty items. There are two types of expressions in the scales: direct and reversed. Direct expressions express negative emotions, and reversed expressions express positive emotions. There are ten (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20th) reversed statements on the state anxiety scale. On the trait anxiety scale, there are seven (1, 6, 7, 10, 13, 16, 19th items) reversed. The total score value obtained from each scale is between minimum 20 and maximum 80. The total score of the reverse expressions is subtracted from the total score obtained for direct expressions. A predetermined and constant value is added to this number. This is 50 for state anxiety and 35 for trait anxiety. The most recent value is the individual's anxiety score. A high score indicates a high anxiety level, a small score indicates a low anxiety level.

Full Information

First Posted
April 6, 2020
Last Updated
August 7, 2020
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04355091
Brief Title
Emotional Freedom Techniques (EFT) and Postpartum Depression
Official Title
Effect of Emotional Freedom Techniques (EFT) on Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
postpartum depression, pregnancy, stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The pregnant women in this group will be informed about the application of EFT with a written material. The pregnant women who have undergone EFT will be interviewed a week or two after the application, and how they feel and whether the problem still disturbs him. If a new issue is reported, similar actions will be repeated for this new issue. The number of EFT sessions was decided based on the condition of the pregnant woman. After all EFT sessions are completed, a re-evaluation (post-test) of Edinburgh Postpartum Depression Scale, Stress Coping Scale and State-Trait Anxiety Inventory will be done. The same participants will be asked to apply the other inventories and the postpartum interview form if she had birth three months and six months after the last application (follow-up). In the follow-up study performed three months after the last application, EFT will be applied to the pregnant women in need.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The participants in this group will be talked about the problems they should have in routine midwifery care, the problems they encounter during pregnancy or postpartum period and the subjects they want to receive information. If necessary, suggestions will be made for problems related to pregnancy, postpartum period or newborn care. Again, with these participants, after the depression risk determination (pre-test), after the interviews ended (post-test), three months and six months after the last application, Edinburgh Postpar All Depression Scale, Stressful Life Events List, Stress Coping Scale. If the pregnant woman has given birth, State-Trait Anxiety Inventory and postnatal interview form will be performed.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Freedom Techniques (EFT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Edinburgh Postpartum Depression Scale scores at 6 months
Description
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.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Stress Coping Styles Scale
Description
This scale is used to determine the coping mechanisms used by the participants in the face of stressful situations.It consists of 30 items and 5 sub-dimensions. High scores from each of the five subscales identified indicate an increase in the use of coping style expressed by that subscale. These subscales and the items are as follows: Self-Confident Approach: 8, 10, 14, 16, 20, 23, 26, Optimistic Approach: 2, 4, 6, 12 18,, Helpless Approach: 3, 7, 11, 19, 22, 25, 27, 28, Submissive Approach: 5, 13, 15, 17, 21, 24, Contacting Social Support: 1, 9, 29, 30. Items 1 and 9 in the scale are reversed. Subgroup scores are obtained by dividing the score from each sub-dimension by the number of items.
Time Frame
Change from baseline in stress coping styles at 6 months
Title
State-Trait Anxiety Inventory
Description
This scale consists of a total of forty items; the "State Anxiety Scale" consisting of twenty items and the "Trait Anxiety Scale" consisting of twenty items. There are two types of expressions in the scales: direct and reversed. Direct expressions express negative emotions, and reversed expressions express positive emotions. There are ten (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20th) reversed statements on the state anxiety scale. On the trait anxiety scale, there are seven (1, 6, 7, 10, 13, 16, 19th items) reversed. The total score value obtained from each scale is between minimum 20 and maximum 80. The total score of the reverse expressions is subtracted from the total score obtained for direct expressions. A predetermined and constant value is added to this number. This is 50 for state anxiety and 35 for trait anxiety. The most recent value is the individual's anxiety score. A high score indicates a high anxiety level, a small score indicates a low anxiety level.
Time Frame
Change from baseline in State-Trait Anxiety scores at 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neslihan Ozcan, Professor
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Cerrahpaşa
City
Istanbul
State/Province
Eyalet/Yerleşke
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Emotional Freedom Techniques (EFT) and Postpartum Depression

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