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The Effect of Emotional Freedom Technique Applied Before Cesarean Section

Primary Purpose

Cesarean Section, Emotional Regulation, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EFT group
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section focused on measuring Cesarean section, Emotional freedom technique, Surgery fear, Traumatic birth perception

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 18 years or older, at 32-38 weeks of gestation, Cesarean delivery planned, Not carrying any risk factors (preeclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy, Single pregnancy, Not having any problems (such as fetal anomaly, intrauterine growth retardation) related to the health of the fetus, Pregnant women who do not have conditions such as infection, wound, scar in the tapping areas. Exclusion Criteria: Diagnosing a risky pregnancy during the research process, Participant's unwillingness to continue with the EFT protocol

Sites / Locations

  • Malatya Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

EFT application will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation.

Women in the control group who will have a cesarean section at 32-38 weeks of gestation will not be interfered with.

Outcomes

Primary Outcome Measures

Subjective Units of Experience- (SUE)
The negative 10 feel the greatest pain, disappointment, fear, stress, sadness, or discomfort imaginable. When it reaches Positive 10, the client feels very different and wonderful. The meanings of the ratings in this range change gradually. The scale has no cutoff score. It is interpreted according to the mean of the scores and its relevance to other variables.

Secondary Outcome Measures

Traumatic Birth Perception Scale
The scale consists of a total of 13 questions covering thoughts and feelings such as anxiety, fear and anxiety that the woman feels when she thinks about the concept of birth. For each problem, a score is given from 0 to 10, whether I'm afraid or afraid. The lowest and highest scores that can be obtained from the scale are 0 and 130. According to the total mean score of the scale, the 0-26 score range is "very low", the 27-52 score range is "low", the 53-78 score range is "moderate", the 79-104 score range is "high", and the 105-130 score range is "very high" indicates the perception of traumatic birth.
Surgical Fear Scale
The scale is in 11-point Likert type, consists of 8 questions and scores between 0 and 10. The scale, each of which consists of 4 items, consists of two sub-dimensions measuring short-term fears and long-term fears related to the source of fear. Items 1 to 4 in the scale measure the fear of short-term results of surgery, while items 5 to 8 measure the fear of long-term results. The items in the scale are evaluated as "0: I am not afraid at all" and "10: I am very afraid".
State anxiety scale
The State Anxiety Scale is an individual's at a certain moment and under certain conditions; It requires him to describe how he feels. The emotions and behaviors expressed in the inventory items are indicated by choosing one of the options "(1) Not at all, (2) A little, (3) A lot and (4) Completely" according to the severity of such experiences. The total score obtained can vary between 20 and 80.
Demographic Descriptive Data
Pregnant information form prepared by the researcher in line with the literature, socio-demographic (pregnant woman's age, education and employment status, income status, family type and place of residence), obstetric (current gestational week and pregnancy history), psycho-social and medical history (desire for pregnancy) status, whether there is a chronic disease) consists of questions.

Full Information

First Posted
December 4, 2022
Last Updated
February 28, 2023
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05646979
Brief Title
The Effect of Emotional Freedom Technique Applied Before Cesarean Section
Official Title
The Effect of Emotional Freedom Technique Applied Before Cesarean Section on Perception of Anxiety, Fear of Surgery and Traumatic Birth
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

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
Since all the follow-up and care of the pregnant during the prenatal period are carried out by the midwives, the care provided by the midwives to the women during the prenatal period plays a key role for the woman to have a comfortable and healthy pregnancy. Midwives should take psychological approaches in order to reduce the negative feelings of women before cesarean section. Considering all these, it is thought that Emotional Freedom Technique, which does not require any invasive intervention, is inexpensive and easy to apply, will contribute to women's feeling better by reducing pre-cesarean anxiety, surgical fear and traumatic birth perception.
Detailed Description
Although childbirth is a normal physiological event for the female body, it causes stress for the woman and brings with it many risks. Cesarean section, which is one of the birth types; It is a surgical procedure that enables delivery to occur through an incision made on the abdominal wall and uterus of the mother. Although the cesarean rate recommended by the World Health Organization (WHO) is 15%, the rate of cesarean section in our country is 52.1% according to the Turkey Demographic and Health Survey. Every surgical procedure to be performed, the decision of surgery and the waiting period may cause anxiety in individuals. Anxiety and fear experienced before surgery; It can cause individuals to experience uneasiness, restlessness and dissatisfaction due to the uncertainty they are in. Preoperative pain, fear of death, the thought that the body will be harmed and suffering, fear of losing consciousness and control due to anesthesia, and the uncertainty associated with anesthesia may cause fear of surgery. Anxiety before cesarean section is multifaceted, and it has been reported that the pregnancy process increases anxiety. In studies, it was determined that the anxiety level of mothers before cesarean section was high. The extreme degree of anxiety and fear plays a very important role in the formation of traumatic perception towards birth. Many methods are used to reduce negative emotions in the prenatal period. Emotional Freedom Technique (EFT), which is one of these methods, is a method used to resolve emotional blockages in the energy body of the person. EFT aims to reveal all the points where there is a possibility of negative emotion experienced in the past and stuck in a part of the body. By focusing on the emotions that negatively affect the person in EFT, the energy flow is regulated with stimulations often made by touch. When administered to pregnant women, it may contribute to a decrease in post-traumatic stress disorder and to reduce the level of anxiety and fear. Since all the follow-up and care of the pregnant during the prenatal period are carried out by the midwives, the care provided by the midwives to the women during the prenatal period plays a key role for the woman to have a comfortable and healthy pregnancy. Midwives should take psychological approaches in order to reduce the negative feelings of women before cesarean section. Considering all these, it is thought that EFT, which does not require any invasive intervention, is inexpensive and easy to apply, will contribute to women's feeling better by reducing pre-cesarean anxiety, surgical fear and traumatic birth perception.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Emotional Regulation, Surgery, Traumatic Birth
Keywords
Cesarean section, Emotional freedom technique, Surgery fear, Traumatic birth perception

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The randomized experiment was designed as a control study.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
EFT application will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Women in the control group who will have a cesarean section at 32-38 weeks of gestation will not be interfered with.
Intervention Type
Behavioral
Intervention Name(s)
EFT group
Intervention Description
EFT protocol will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation.
Primary Outcome Measure Information:
Title
Subjective Units of Experience- (SUE)
Description
The negative 10 feel the greatest pain, disappointment, fear, stress, sadness, or discomfort imaginable. When it reaches Positive 10, the client feels very different and wonderful. The meanings of the ratings in this range change gradually. The scale has no cutoff score. It is interpreted according to the mean of the scores and its relevance to other variables.
Time Frame
Each participant will be evaluated for 1 week.
Secondary Outcome Measure Information:
Title
Traumatic Birth Perception Scale
Description
The scale consists of a total of 13 questions covering thoughts and feelings such as anxiety, fear and anxiety that the woman feels when she thinks about the concept of birth. For each problem, a score is given from 0 to 10, whether I'm afraid or afraid. The lowest and highest scores that can be obtained from the scale are 0 and 130. According to the total mean score of the scale, the 0-26 score range is "very low", the 27-52 score range is "low", the 53-78 score range is "moderate", the 79-104 score range is "high", and the 105-130 score range is "very high" indicates the perception of traumatic birth.
Time Frame
It will be applied as a post-test 1 week after it is applied as a pre-test to the pregnants between 32-38 weeks included in the study.
Title
Surgical Fear Scale
Description
The scale is in 11-point Likert type, consists of 8 questions and scores between 0 and 10. The scale, each of which consists of 4 items, consists of two sub-dimensions measuring short-term fears and long-term fears related to the source of fear. Items 1 to 4 in the scale measure the fear of short-term results of surgery, while items 5 to 8 measure the fear of long-term results. The items in the scale are evaluated as "0: I am not afraid at all" and "10: I am very afraid".
Time Frame
It will be applied as a post-test 1 week after it is applied as a pre-test to the pregnants between 32-38 weeks included in the study.
Title
State anxiety scale
Description
The State Anxiety Scale is an individual's at a certain moment and under certain conditions; It requires him to describe how he feels. The emotions and behaviors expressed in the inventory items are indicated by choosing one of the options "(1) Not at all, (2) A little, (3) A lot and (4) Completely" according to the severity of such experiences. The total score obtained can vary between 20 and 80.
Time Frame
It will be applied as a post-test 1 week after it is applied as a pre-test to the pregnants between 32-38 weeks included in the study.
Title
Demographic Descriptive Data
Description
Pregnant information form prepared by the researcher in line with the literature, socio-demographic (pregnant woman's age, education and employment status, income status, family type and place of residence), obstetric (current gestational week and pregnancy history), psycho-social and medical history (desire for pregnancy) status, whether there is a chronic disease) consists of questions.
Time Frame
It will be obtained in 1 month at the beginning of the research.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older, at 32-38 weeks of gestation, Cesarean delivery planned, Not carrying any risk factors (preeclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy, Single pregnancy, Not having any problems (such as fetal anomaly, intrauterine growth retardation) related to the health of the fetus, Pregnant women who do not have conditions such as infection, wound, scar in the tapping areas. Exclusion Criteria: Diagnosing a risky pregnancy during the research process, Participant's unwillingness to continue with the EFT protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sinem Güven Santur
Phone
05424640068
Email
ysinemguven@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zeliha Ozşahin
Phone
4223410220
Ext
3792
Email
zeliha.ozsahin@inonu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Karataş Okyay
Organizational Affiliation
https://akademik.ksu.edu.tr/Default.aspx?kod=CfTMEAi69foG7wFizm48ztSNEmgmVjdANJTT1Xcj9gA=
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeliha Özşahin
Organizational Affiliation
https://avesis.inonu.edu.tr/zeliha.ozsahin/bilimselfaaliyetler
Official's Role
Study Director
Facility Information:
Facility Name
Malatya Training and Research Hospital
City
Malatya
State/Province
Kayseri
ZIP/Postal Code
44000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinem GüvenSantur, phd
Phone
05424640068
Email
ysinemguven@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
In the research, data collection forms will be filled by face-to-face interview method. Data will be collected with Personal Information Form, State Anxiety Scale (STAI-I), Surgical Fear Scale, Traumatic Birth Perception Scale (TDAS) and Subjective Units of Experience (SUE) Scale.

Learn more about this trial

The Effect of Emotional Freedom Technique Applied Before Cesarean Section

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