- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05646979
The Effect of Emotional Freedom Technique Applied Before Cesarean Section
The Effect of Emotional Freedom Techniques on Anxiety, Surgical Fear and Traumatic Birth Perception of Pregnant Women Who Will Have a Planned Caesarean Section: A Randomised Controlled Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kayseri
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Malatya, Kayseri, Turkey (Türkiye), 44000
- Malatya Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
EFT application will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation.
|
EFT protocol will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation.
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No Intervention: Control group
Women in the control group who will have a cesarean section at 32-38 weeks of gestation will not be interfered with.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Units of Experience- (SUE)
Time Frame: Each participant will be evaluated for 1 week.
|
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.
|
Each participant will be evaluated for 1 week.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Traumatic Birth Perception Scale
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.
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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.
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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.
|
|
Surgical Fear Scale
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.
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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".
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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.
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State anxiety scale
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.
|
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.
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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.
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Demographic Descriptive Data
Time Frame: It will be obtained in 1 month at the beginning of the research.
|
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.
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It will be obtained in 1 month at the beginning of the research.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Esra Karataş Okyay, https://akademik.ksu.edu.tr/Default.aspx?kod=CfTMEAi69foG7wFizm48ztSNEmgmVjdANJTT1Xcj9gA=
- Study Director: Zeliha Özşahin, https://avesis.inonu.edu.tr/zeliha.ozsahin/bilimselfaaliyetler
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Inonu Universty, Malatya
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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