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临床试验/NCT07156279
NCT07156279进行中(未招募)不适用

The Effect of Emotional Freedom Technique (EFT) Applied to Pregnant Women Before Cesarean Delivery on Surgical Fear and Intra-operative Vital Signs

Bingol University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Change in Surgical Fear Score (Surgical Fear Scale, total)

研究概览

简要总结

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. Does EFT Technique reduce surgical fear level?
  2. Does EFT Technique affect intraoperative hemodynamics?
  3. Is EFT Technique effective on newborn Apgar score?
  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.

详细描述

Surgical interventions are often performed to secure people's lives. Although these applications are routine procedures for health professionals, exposure to a medical or surgical intervention in the operating room environment is a stress factor as it is unusual for most patients . Studies show that patients waiting for surgical intervention experience intense fear, anxiety, and anxiety in the preoperative period and that this is a situation that is often ignored .

Studies indicate that younger patients have higher anxiety levels than older patients and female patients have higher anxiety levels than male patients. Again, the results of some studies examining the factors causing anxiety and fear suggest that obstetric surgeries may cause more anxiety in individuals than some other surgeries .

Cesarean section (C/S) delivery represents one of the most common surgical interventions, which has increased significantly in many parts of the world in recent years .Cesarean section (C/S) rates are increasing worldwide, making C/S the most common intraperitoneal surgical intervention . According to Turkish population and health survey 2018 data, the cesarean section rate in our country is 52%, which is unfortunately much higher than the cesarean section rate recommended by WHO (World Health Organization). Again, one in three women in the United States gives birth by cesarean section, making C/S one of the most common surgical procedures in the country. The fact that caesarean section rates have increased so much in all countries of the world, developed and developing alike, should support efforts to reduce this method of delivery and promote normal delivery methods, but should also aim to minimize the side effects of this surgical procedure and the accompanying anesthesia and focus equally on postoperative maternal and fetal health outcomes.

The anxiety and fear experienced by pregnant women before these surgical interventions, the frequency of which has increased considerably in all countries of the world, are often ignored for various reasons, as in other surgeries. However, in addition to the fear and anxiety caused by surgical intervention in pregnant women before this intervention, the problems that may occur in the baby to be born are an additional cause of fear and anxiety. The results of the studies suggest that preoperative emotional states and fears of the patients should be determined and appropriate interventions should be made, since the preoperative emotional states and fears of the patients will affect compliance with the surgical process.

In C/S operations, spinal anesthesia technique is preferred in the first place due to its ease of application.Although spinal anesthesia provides significant benefits compared to general anesthesia, it often leads to hypotension with an incidence of up to 60% to 70% due to sympathetic nervous system blockade . Hypotension after spinal anesthesia is a common complication that can have adverse effects on the well-being of both the laboring woman and the fetus . Prolonged hypotension leads to cardiovascular problems and additional organ damage. At the same time, decreased placental blood flow in utero leads to fetal hypoxia, acidosis, and thus affected fetal health and lower Apgar scores. Since intraoperative hypotension is associated with increased patient morbidity, it is very important to maintain hemodynamics in cesarean section operations, especially in the perinatal period before fetal delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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,

研究组 & 干预措施

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.

干预措施: EFT(Emotional Freedom Technique) (Behavioral)

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.

结局指标

主要结局

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

时间窗: 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.

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.

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

时间窗: 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.

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.

次要结局

  • 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.)
  • Estimated Blood Loss (EBL)(From intraoperative baseline (before spinal anesthesia and zero minutes after intrathecal injection) until recovery room exit on the same operative day.)
  • 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.)
  • Estimated Blood Loss (EBL)(From intraoperative baseline (before spinal anesthesia and zero minutes after intrathecal injection) until recovery room exit on the same operative day.)
  • Apgar Score at 1 and 5 minutes(In the 1st and 5th minutes after birth)
  • Change in Subjective Units of Experience (SUE) Score(Between two preoperative measurements (same day, before surgery).)

研究者

发起方
Bingol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Derya Bingöl

LECTURER

Bingol University

研究点 (1)

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