Effect of Emotional Freedom Technique on Surgical Fear and Vital Signs in Women Undergoing Cesarean Section

NCT07156279 | Active Not Recruiting DMC

• 1 other identifier: BINGOL UNİVERSİTY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical interventions are unusual interventions that can cause anxiety and fear in individuals. It is known that anxiety and fear experienced during this period affect the intraoperative and postoperative process. Emotional Freedom Technique (EFT) is a type of energy psychotherapy that has no side effects and its effect on fear has been demonstrated in many studies. This study will be conducted to determine the effect of Emotional Freedom Technique (EFT) applied in the preoperative period in pregnant women planned to have a cesarean section on surgical fear, intraoperative hemodynamics and newborn Apgar score. Research questions:

1. 1.Does EFT Technique reduce surgical fear level?
2. 2.Does EFT Technique affect intraoperative hemodynamics?
3. 3.Is EFT Technique effective on newborn Apgar score?
4. 4.Is there a relationship between surgical fear and intraoperative hemodynamics and newborn Apgar score? The research will be conducted in two stages in the Gynecology and Obstetrics Department of Bingöl State Hospital and the operating room unit of the same hospital. The universe of the study will consist of women who are scheduled for elective cesarean delivery and who do not have a risky pregnancy and who are admitted to Bingöl State Hospital. Considering the possibility of data loss due to various reasons during the study process, it is planned to be completed on a total of 60 women, 30 in the experimental group and 30 in the control group.

Conditions

Cesarean Section; Preoperative Anxiety

Keywords

Emotional Freedom Techniques (EFT); Intraoperative Hemodynamics; Apgar Score; Surgical Fear; Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• Change in Surgical Fear Score (Surgical Fear Scale, total)

  Change in the total score of the 8-item Surgical Fear Scale (range 0-80; each item scored 0-10). Scores will be assessed before and immediately after the EFT session in the intervention group, and at equivalent time points in the control group. Reporting will be done as the change score between the two time points and/or as a percentage change.

  From baseline preoperative assessment on the day of surgery (after hospital admission and before EFT application) to thirty minutes after the EFT session, within the same preoperative day before transfer to the operating room.

Secondary Outcomes (8)

• Intraoperative Heart Rate (HR)

  From intraoperative baseline before spinal anesthesia until recovery room exit on the same operative day.

• Intraoperative Blood Pressure (systolic, diastolic, mean arterial pressure)

  From intraoperative baseline before spinal anesthesia until recovery room exit on the same operative day.

• Intraoperative Oxygen Saturation (SpO₂)

  From intraoperative baseline (before spinal anesthesia and zero minutes after intrathecal injection) until recovery room exit on the same operative day.

• Incidence of Intraoperative Hypotension

  From intraoperative baseline (before spinal anesthesia and zero minutes after intrathecal injection) until recovery room exit on the same operative day.

• Use of Vasopressors During Surgery

  From intraoperative baseline (before spinal anesthesia and zero minutes after intrathecal injection) until recovery room exit on the same operative day.

Study Arms (2)

EFT (Emotional Freedom Technique)

EXPERIMENTAL

Participants in the experimental group will receive Emotional Freedom Technique (EFT) sessions lasting 15-20 minutes. EFT is a behavioral intervention in which individuals tap with their fingertips on specific acupressure points on the head and chest while focusing on a target issue. The technique is non-invasive, painless, and simple to apply. Sessions also include the use of positive affirmations during tapping.

Behavioral: EFT(Emotional Freedom Technique)

Control Group

NO INTERVENTION

No intervention will be applied to participants in the control group. They will complete study questionnaires and receive routine information only.

Interventions

EFT(Emotional Freedom Technique) BEHAVIORAL

EFT is a behavioral intervention in which participants tap with their fingertips on specific acupressure points while focusing on a target issue. The technique is non-invasive, painless, and simple to apply. Sessions also include the use of positive affirmations during tapping.

Also known as: Emotional freedom technique, EFT

EFT (Emotional Freedom Technique)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Since pregnant women scheduled for cesarean delivery will be included in the study, individuals whose biological sex is female will be included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those who volunteer to participate in the study,
• Those who can understand and speak Turkish,
• Those who are ASA II in the American Anesthesiologists Association risk classification,
• Pregnant women who will undergo elective CS,
• Women without a risky pregnancy (gestational diabetes mellitus, preeclampsia, eclampsia, HT patients, CHD, etc., multiple pregnancy, pregnancy with in vitro treatment),
• Pregnant women between the ages of 20-40,
• Pregnant women without any psychiatric comorbidities,
• Pregnant women with a Fear score below 0 according to the SUE Scale. (Pregnant women who state that they are afraid of surgical procedures)

You may not qualify if:

• Those with serious heart, lung, liver disease, kidney failure, bleeding diathesis, fever, infection, allergy to the drugs to be used,
• Patients with hypothermia and acid-base disorders and electrolyte disorders,
• Those taking antibiotics, anticonvulsants, antiarrhythmics, cholinesterase inhibitors,
• Pregnant women who decide to undergo general anesthesia for various reasons,
• Pregnant women at risk,

Sponsors & Collaborators

• Bingol University: lead

Study Sites (1)

Bingöl Üniversitesi

Bingöl, 12000, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Model Details: Emotional Freedom Technique-EFT EFT basically involves clicking and touching acupuncture points, needles are not used, there is no invasive intervention, there are affirmation suggestions, it is an easy, painless, simple but effective method that can be done in minutes. Many studies have shown that in addition to the insertion of acupuncture needles, acupuncture stimulation can also be provided by vacuum suction, touching, ultrasound and acupressure, and randomized controlled studies have shown that somatic stimulation (acupressure) has the same effect as needles. (Craig, 2004) It is performed by applying kinetic energy to certain meridians on the head and chest with the fingertips. The points where the tapping is done are the end points of the meridians in the body. They are located symmetrically on both sides of the body. Since these points are close to the skin surface, they are points that are more easily reached than the deeper buried parts of the meridians.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: September 5, 2025
• Study Start: March 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 15, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

TU (1)