ClinicalTrials.gg
Not yet recruitingNCT06953037Updated May 1, 2025

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

An interventional study of acupressure in Caesarean Section, Pregnant Women and Anxiety Disorder, sponsored by Eastern Mediterranean University. Not yet recruiting at 2 sites in Cyprus. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Caesarean Section
  • Pregnant Women
  • Anxiety Disorder

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Keywords

  • pregnant women
  • caesarean section
  • anxiety
  • fetal heart rate
  • accupressure
03

In context

Anxiety Disorders

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 64 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Eastern Mediterranean University is the lead sponsor of 141 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 over 25,
  • Having previous acupressure experience,
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    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.

    Other: acupressure

  • No intervention
    control

    routine nursing care

Interventions

  • Otheracupressure

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 DAY

07

Study locations

2 sites
08

References and documents

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 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06953037
Responsible party
Arzu Abiç (Asist Prof Dr, Eastern Mediterranean University) — Principal investigator
First posted
May 1, 2025
Start date
May 15, 2025 (estimated)
Primary completion
Jul 5, 2025 (estimated)
Completion
Jul 5, 2025 (estimated)
Last update
May 1, 2025

Study contacts

Arzu Abiç, Asistant Prof
Contact
arzu.abic@emu.edu.tr
+905488506060

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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