Caesarean SectionNCT06953037
Effects of Acupressure Applied Before Cesarean Delivery on Anxiety, Physiological Parameters and Fetal Heart Rate
A study testing acupressure in people with Caesarean Section and Pregnant Women, run by Eastern Mediterranean University at 2 sites in Cyprus.
Trial summary
Cesarean section is the most commonly preferred surgical method in cases where vaginal birth is not possible or complications that may endanger the health of the mother and baby occur. Cesarean section rates are increasing worldwide. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section, Pregnant Women, Anxiety Disorder
- What is being tested?
- acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesCyprus
- Study dates
- 15 May 2025to 5 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agree to participate in the study,
- Be between the ages of 18-45,
- Have a caesarean section between 37-40 weeks,
- Not have a risky pregnancy,
- Have spinal anesthesia,
Who cannot join
- Not having anxiety 1 hour before the cesarean section,
- Having a risky pregnancy,
- Having a chronic disease,
- Having a severe systemic disease,
- Not receiving spinal anesthesia,
- Having a body mass index over 25,
- Having previous acupressure experience,
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus2 sites
Eastern Mediterranean University
Famagusta, Ammochostos, 33010
Arzu Abiç, ASİSTANT PROF, 05488506060
Eastern Mediterranean University
Famagusta, Ammochostos, 3330
About this study
Official title: Effects of Acupressure Applied Before Cesarean Delivery on Anxiety, Physiological Parameters and Fetal Heart Rate: A Randomized Controlled Trial
Cesarean section is the most commonly preferred surgical method in cases where vaginal birth is not possible or complications that may endanger the health of the mother and baby occur. Cesarean section rates are increasing worldwide. According to the latest data (2010-2018) from 154 countries covering 94.5% of live births in the world, 21.1% of women have cesarean section births and it is estimated that this rate will increase to 28.5% by 2030. According to the Centers for Disease Control and Prevention (CDC), the cesarean section rate in the USA, which was 32.1% in 2022, increased to 32.4% in 2023. When the cesarean section rates of the Turkey Demographic Health Survey (TDHS) are examined, the rate, which was 7% in 1993, increased to 52% in 2018, an increase of 45% is observed. In the TRNC, this rate was 11.1% in 1981, but in 2017 this rate increased by an average of 7 times, reaching 72.5%. Pregnant women tend to have cesarean sections because they are affected by the risks that will occur during birth, negative birth stories told among the public, and painful birth scenes seen on social media. Studies have shown that despite the high rates of cesarean sections in pregnant women's birth methods, a significant increase in women's anxiety levels is observed. While waiting for the surgery, pre-operative anxiety, fear of the procedure, etc. are more common than other feelings and symptoms.Studies have also shown that anxiety increases in patient rooms, the night before surgery, and when moving to the operating table. In a study conducted by Lopez, the most important causes of preoperative anxiety were listed as fear of the hospital environment (35%), fear of surgery (33%), fear of anesthesia (45%), and unawareness of the surgery (45%). Concerns about the success of the operation (29.3%), fear of postoperative prognosis (19.5%), and surgical complications (11.4%) are the most common causes of preoperative anxiety. High levels of anxiety experienced before surgery cause increased heart rate, blood pressure, and oxygen consumption during surgery.
Controlling and managing preoperative anxiety is one of the most important goals of nursing care worldwide, as in cesarean cases. Mothers need to relax mentally and physically after cesarean sections so that they can care for their babies after birth. A common way to control preoperative anxiety is to use sedatives, but these medications can cause side effects. Therefore, acupressure, which is a non-invasive, low-cost, uncomplicated and non-pharmacological method due to fewer complications, can be used to reduce preoperative anxiety. Acupressure is the application of pressure to stimulate acupoints and meridian lines using an object or fingers, without the use of needles. Acupressure is a simple treatment approach and can be applied by nurses or patients who have received the necessary training, because it is simple and does not require any equipment.
Read the detailed description
Cesarean section is the most commonly preferred surgical method in cases where vaginal birth is not possible or complications that may endanger the health of the mother and baby occur. Cesarean section rates are increasing worldwide. According to the latest data (2010-2018) from 154 countries covering 94.5% of live births in the world, 21.1% of women have cesarean section births and it is estimated that this rate will increase to 28.5% by 2030. According to the Centers for Disease Control and Prevention (CDC), the cesarean section rate in the USA, which was 32.1% in 2022, increased to 32.4% in 2023. When the cesarean section rates of the Turkey Demographic Health Survey (TDHS) are examined, the rate, which was 7% in 1993, increased to 52% in 2018, an increase of 45% is observed. In the TRNC, this rate was 11.1% in 1981, but in 2017 this rate increased by an average of 7 times, reaching 72.5%. Pregnant women tend to have cesarean sections because they are affected by the risks that will occur during birth, negative birth stories told among the public, and painful birth scenes seen on social media. Studies have shown that despite the high rates of cesarean sections in pregnant women's birth methods, a significant increase in women's anxiety levels is observed. While waiting for the surgery, pre-operative anxiety, fear of the procedure, etc. are more common than other feelings and symptoms.Studies have also shown that anxiety increases in patient rooms, the night before surgery, and when moving to the operating table. In a study conducted by Lopez, the most important causes of preoperative anxiety were listed as fear of the hospital environment (35%), fear of surgery (33%), fear of anesthesia (45%), and unawareness of the surgery (45%). Concerns about the success of the operation (29.3%), fear of postoperative prognosis (19.5%), and surgical complications (11.4%) are the most common causes of preoperative anxiety. High levels of anxiety experienced before surgery cause increased heart rate, blood pressure, and oxygen consumption during surgery.
Controlling and managing preoperative anxiety is one of the most important goals of nursing care worldwide, as in cesarean cases. Mothers need to relax mentally and physically after cesarean sections so that they can care for their babies after birth. A common way to control preoperative anxiety is to use sedatives, but these medications can cause side effects. Therefore, acupressure, which is a non-invasive, low-cost, uncomplicated and non-pharmacological method due to fewer complications, can be used to reduce preoperative anxiety. Acupressure is the application of pressure to stimulate acupoints and meridian lines using an object or fingers, without the use of needles. Acupressure is a simple treatment approach and can be applied by nurses or patients who have received the necessary training, because it is simple and does not require any equipment.
- Conditions
- Caesarean Section, Pregnant Women, Anxiety Disorder
- Being tested
- acupressure
- Keywords
- pregnant women, caesarean section, anxiety, fetal heart rate, accupressure
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
The application will be made to the women in the acupressure group after applying the data collection forms (Personal Information Form, STAI-1 and Physiological Parameters and Fetal Heart Rate Chart) 1 hour before the cesarean section. The application will be made to the women in the acupressure group by manually pressing the SP6 and HT7 points with the index or middle finger for 5 seconds to a depth of 1-1.5 cm in the order determined by lot, then resting for 2 seconds and continuing the application for 2 minutes. Anxiety, physiological parameters and fhr will be measured again 40 minutes after the application. The data collection forms (descriptive characteristics form, loss, physiological parameters, fhr) will be applied to the women in the control group 1 hour before the cesarean section. No intervention will be made to the women in the control group. Anxiety, physiological parameters and fhr will be measured again 40 minutes later.
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | The acupressure points to be used in the study are the San Yin Jiao points on the spleen meridian (SP6) located on the inside of the lower leg, 4 fingers above the ankle and behind the tibia, which are effective in reducing anxiety, and the Shen Men points on the heart meridian (HT7) located in the small pit between the pisiform and ulna (elbow) bones in the transverse wrist fold. Acupressure will be applied to the women in the acupressure group by a certified researcher. Receives: Other: acupressure |
| control | No intervention | routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Scale
The state anxiety scale was developed by Spielberg et al. (1970) and adapted to Turkish by Öner and Le Compte (1983). The State Anxiety Scale, which was developed to measure an individual's anxiety at a certain moment, is a 20-item, 4-point Likert-type scale (1 Not at all, 2 A little, 3 A lot, 4 Completely) that indicates the frequency of the feelings and behaviors expressed by the individual. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 in the state anxiety scale contain reversed statements. The scale is scored by adding 50 points to the difference between the total weighted scores of the direct statements and the reverse statements. Accordingly, the lowest score that can be obtained from the scale is 20, and the highest score is 80. An increase in the score obtained from the scale indicates that state anxiety has developed. A score below 36 on the scale indicates no anxiety, a score between 37-42 indicates mild anxiety, and a score of 42 and above indicates high anxiety.
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 May 2025 (estimated)
- Primary completion5 Jul 2025 (estimated)
- Study completion5 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Abiç, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953037
- Sponsor's protocol ID
- ETK00-2024-0222
- Other IDs
- EASTERN MEDİTERRANEAN UNI
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie W, Ye F, Yan X, Cao M, Ho MH, Kwok JYY, Lee JJ. Acupressure can reduce preoperative anxiety in adults with elective surgery: A systematic review and meta-analysis of randomised controlled trials. Int J Nurs Stud. 2023 Sep;145:104531. doi: 10.1016/j.ijnurstu.2023.104531. Epub 2023 May 22.
PubMed 37321140
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acupressure Applied Before Cesarean Delivery on Anxiety, Physiological Parameters and Fetal Heart Rate: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06953037
- Acronym / sponsor ID
- ETK00-2024-0222
- Conditions
- Caesarean Section, Pregnant Women, Anxiety Disorder
- Keywords
- pregnant women, caesarean section, anxiety, fetal heart rate, accupressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 5 Jul 2025 (estimated)
- Study completion
- 5 Jul 2025 (estimated)
- First posted
- 1 May 2025 (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.
Cesarean section is the most commonly preferred surgical method in cases where vaginal birth is not possible or complications that may endanger the health of the mother and baby occur. Cesarean section rates are increasing worldwide. According to the latest data (2010-2018) from 154 countries covering 94.5% of live births in the world, 21.1% of women have cesarean section births and it is estimated that this rate will increase to 28.5% by 2030. According to the Centers for Disease Control and Prevention (CDC), the cesarean section rate in the USA, which was 32.1% in 2022, increased to 32.4% in 2023. When the cesarean section rates of the Turkey Demographic Health Survey (TDHS) are examined, the rate, which was 7% in 1993, increased to 52% in 2018, an increase of 45% is observed. In the TRNC, this rate was 11.1% in 1981, but in 2017 this rate increased by an average of 7 times, reaching 72.5%. Pregnant women tend to have cesarean sections because they are affected by the risks that will occur during birth, negative birth stories told among the public, and painful birth scenes seen on social media. Studies have shown that despite the high rates of cesarean sections in pregnant women's birth methods, a significant increase in women's anxiety levels is observed. While waiting for the surgery, pre-operative anxiety, fear of the procedure, etc. are more common than other feelings and symptoms.Studies have also shown that anxiety increases in patient rooms, the night before surgery, and when moving to the operating table. In a study conducted by Lopez, the most important causes of preoperative anxiety were listed as fear of the hospital environment (35%), fear of surgery (33%), fear of anesthesia (45%), and unawareness of the surgery (45%). Concerns about the success of the operation (29.3%), fear of postoperative prognosis (19.5%), and surgical complications (11.4%) are the most common causes of preoperative anxiety. High levels of anxiety experienced before surgery cause increased heart rate, blood pressure, and oxygen consumption during surgery.
Controlling and managing preoperative anxiety is one of the most important goals of nursing care worldwide, as in cesarean cases. Mothers need to relax mentally and physically after cesarean sections so that they can care for their babies after birth. A common way to control preoperative anxiety is to use sedatives, but these medications can cause side effects. Therefore, acupressure, which is a non-invasive, low-cost, uncomplicated and non-pharmacological method due to fewer complications, can be used to reduce preoperative anxiety. Acupressure is the application of pressure to stimulate acupoints and meridian lines using an object or fingers, without the use of needles. Acupressure is a simple treatment approach and can be applied by nurses or patients who have received the necessary training, because it is simple and does not require any equipment.
Detailed description
Cesarean section is the most commonly preferred surgical method in cases where vaginal birth is not possible or complications that may endanger the health of the mother and baby occur. Cesarean section rates are increasing worldwide. According to the latest data (2010-2018) from 154 countries covering 94.5% of live births in the world, 21.1% of women have cesarean section births and it is estimated that this rate will increase to 28.5% by 2030. According to the Centers for Disease Control and Prevention (CDC), the cesarean section rate in the USA, which was 32.1% in 2022, increased to 32.4% in 2023. When the cesarean section rates of the Turkey Demographic Health Survey (TDHS) are examined, the rate, which was 7% in 1993, increased to 52% in 2018, an increase of 45% is observed. In the TRNC, this rate was 11.1% in 1981, but in 2017 this rate increased by an average of 7 times, reaching 72.5%. Pregnant women tend to have cesarean sections because they are affected by the risks that will occur during birth, negative birth stories told among the public, and painful birth scenes seen on social media. Studies have shown that despite the high rates of cesarean sections in pregnant women's birth methods, a significant increase in women's anxiety levels is observed. While waiting for the surgery, pre-operative anxiety, fear of the procedure, etc. are more common than other feelings and symptoms.Studies have also shown that anxiety increases in patient rooms, the night before surgery, and when moving to the operating table. In a study conducted by Lopez, the most important causes of preoperative anxiety were listed as fear of the hospital environment (35%), fear of surgery (33%), fear of anesthesia (45%), and unawareness of the surgery (45%). Concerns about the success of the operation (29.3%), fear of postoperative prognosis (19.5%), and surgical complications (11.4%) are the most common causes of preoperative anxiety. High levels of anxiety experienced before surgery cause increased heart rate, blood pressure, and oxygen consumption during surgery.
Controlling and managing preoperative anxiety is one of the most important goals of nursing care worldwide, as in cesarean cases. Mothers need to relax mentally and physically after cesarean sections so that they can care for their babies after birth. A common way to control preoperative anxiety is to use sedatives, but these medications can cause side effects. Therefore, acupressure, which is a non-invasive, low-cost, uncomplicated and non-pharmacological method due to fewer complications, can be used to reduce preoperative anxiety. Acupressure is the application of pressure to stimulate acupoints and meridian lines using an object or fingers, without the use of needles. Acupressure is a simple treatment approach and can be applied by nurses or patients who have received the necessary training, because it is simple and does not require any equipment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Other: acupressureThe acupressure points to be used in the study are the San Yin Jiao points on the spleen meridian (SP6) located on the inside of the lower leg, 4 fingers above the ankle and behind the tibia, which are effective in reducing anxiety, and the Shen Men points on the heart meridian (HT7) located in the small pit between the pisiform and ulna (elbow) bones in the transverse wrist fold. Acupressure will be applied to the women in the acupressure group by a certified researcher. |
| control | No intervention | –routine nursing care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Agree to participate in the study,
- Be between the ages of 18-45,
- Have a caesarean section between 37-40 weeks,
- Not have a risky pregnancy,
- Have spinal anesthesia,
Key exclusion criteria (7 listed)
- Not having anxiety 1 hour before the cesarean section,
- Having a risky pregnancy,
- Having a chronic disease,
- Having a severe systemic disease,
- Not receiving spinal anesthesia,
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 |
|---|---|---|
| acupressureThe application will be made to the women in the acupressure group after applying the data collection forms (Personal Information Form, STAI-1 and Physiological Parameters and Fetal Heart Rate Chart) 1 hour before the cesarean section. The application will be made to the women in the acupressure group by manually pressing the SP6 and HT7 points with the index or middle finger for 5 seconds to a depth of 1-1.5 cm in the order determined by lot, then resting for 2 seconds and continuing the application for 2 minutes. Anxiety, physiological parameters and fhr will be measured again 40 minutes after the application. The data collection forms (descriptive characteristics form, loss, physiological parameters, fhr) will be applied to the women in the control group 1 hour before the cesarean section. No intervention will be made to the women in the control group. Anxiety, physiological parameters and fhr will be measured again 40 minutes later. | Other | acupressure |
Primary outcome
State Anxiety Scale
Time frame: 1 DAY
The state anxiety scale was developed by Spielberg et al. (1970) and adapted to Turkish by Öner and Le Compte (1983). The State Anxiety Scale, which was developed to measure an individual's anxiety at a certain moment, is a 20-item, 4-point Likert-type scale (1 Not at all, 2 A little, 3 A lot, 4 Completely) that indicates the frequency of the feelings and behaviors expressed by the individual. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 in the state anxiety scale contain reversed statements. The scale is scored by adding 50 points to the difference between the total weighted scores of the direct statements and the reverse statements. Accordingly, the lowest score that can be obtained from the scale is 20, and the highest score is 80. An increase in the score obtained from the scale indicates that state anxiety has developed. A score below 36 on the scale indicates no anxiety, a score between 37-42 indicates mild anxiety, and a score of 42 and above indicates high anxiety.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 37321140Xie W, Ye F, Yan X, Cao M, Ho MH, Kwok JYY, Lee JJ. Acupressure can reduce preoperative anxiety in adults with elective surgery: A systematic review and meta-analysis of randomised controlled trials. Int J Nurs Stud. 2023 Sep;145:104531. doi: 10.1016/j.ijnurstu.2023.104531. Epub 2023 May 22.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Caesarean Section and Pregnant Women, run by Eastern Mediterranean University at 2 sites in Cyprus.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arzu Abiç, Asistant Prof (+905488506060, arzu.abic@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Scale (time frame: 1 DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06953037, which also lists 1 linked publication.
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 1 May 2025.