Cesarean SectionNCT05646979
The Effect of Emotional Freedom Technique Applied Before Cesarean Section
A study testing EFT group in people with Cesarean Section and Emotional Regulation, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Emotional Regulation, Surgery
- What is being tested?
- EFT group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosing a risky pregnancy during the research process,
- Participant's unwillingness to continue with the EFT protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Training and Research Hospital
Malatya, Kayseri, 44000
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Cesarean Section, Emotional Regulation, Surgery, Traumatic Birth
- Being tested
- EFT group
- Keywords
- Cesarean section, Emotional freedom technique, Surgery fear, Traumatic birth perception
- Medical subject headings
- Emotional Regulation, Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFT groupBehavioural
EFT protocol will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | EFT application will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation. Receives: Behavioral: EFT group |
| Control group | No intervention | Women in the control group who will have a cesarean section at 32-38 weeks of gestation will not be interfered with. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each participant will be evaluated for 1 week.
Secondary outcomes (4)
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.
Measured: 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
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".
Measured: 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.
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.
Measured: 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.
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.
Measured: It will be obtained in 1 month at the beginning of the research.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start31 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized experiment was designed as a control study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem GUVEN Santur, Inonu University
- Investigators
- Esra Karataş Okyay, Principal investigator, https://akademik.ksu.edu.tr/Default.aspx?kod=CfTMEAi69foG7wFizm48ztSNEmgmVjdANJTT1Xcj9gA=Zeliha Özşahin, Study director, https://avesis.inonu.edu.tr/zeliha.ozsahin/bilimselfaaliyetler
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646979
- Sponsor's protocol ID
- Inonu Universty, Malatya
- Status last verified
- Sep 2025
- First submitted
- 4 Dec 2022
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05646979
- Acronym / sponsor ID
- Inonu Universty, Malatya
- Conditions
- Cesarean Section, Emotional Regulation, Surgery, Traumatic Birth
- Keywords
- Cesarean section, Emotional freedom technique, Surgery fear, Traumatic birth perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The randomized experiment was designed as a control study.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: EFT groupEFT application will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation. |
| Control group | No intervention | –Women in the control group who will have a cesarean section at 32-38 weeks of gestation will not be interfered with. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- Diagnosing a risky pregnancy during the research process,
- Participant's unwillingness to continue with the EFT protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EFT groupEFT protocol will be applied to the women in the experimental group who will have a cesarean section at 32-38 weeks of gestation. | Behavioural | Experimental group |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
Demographic Descriptive Data
Time frame: It will be obtained in 1 month at the beginning of the research.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No. 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.
Related trials for Cesarean Section
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Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
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Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Karataş Okyay principal investigator
https://akademik.ksu.edu.tr/Default.aspx?kod=CfTMEAi69foG7wFizm48ztSNEmgmVjdANJTT1Xcj9gA=
Zeliha Özşahin study director
https://avesis.inonu.edu.tr/zeliha.ozsahin/bilimselfaaliyetler
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFT group in people with Cesarean Section and Emotional Regulation, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Units of Experience- (SUE) (time frame: Each participant will be evaluated for 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.