Effects of Acupressure Applied Before Cesarean Delivery on Anxiety, Physiological Parameters and Fetal Heart Rate

NCT ID: NCT06953037

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-07-05

Brief Summary

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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

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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

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Caesarean Section Pregnant Women Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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acupressure

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.

Group Type EXPERIMENTAL

acupressure

Intervention Type OTHER

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.

control

routine nursing care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acupressure

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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,

Exclusion Criteria

* 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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eastern Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

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Arzu Abiç

Asist Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eastern Mediterranean University

Famagusta, Ammochostos, Cyprus

Site Status

Eastern Mediterranean University

Famagusta, Ammochostos, Cyprus

Site Status

Countries

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Cyprus

Central Contacts

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Arzu Abiç, Asistant Prof

Role: CONTACT

+905488506060

Facility Contacts

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Arzu Abiç, ASİSTANT PROF

Role: primary

05488506060

References

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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.

Reference Type BACKGROUND
PMID: 37321140 (View on PubMed)

Related Links

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Other Identifiers

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EASTERN MEDİTERRANEAN UNI

Identifier Type: OTHER

Identifier Source: secondary_id

ETK00-2024-0222

Identifier Type: -

Identifier Source: org_study_id

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