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临床试验/NCT06795828
NCT06795828已完成不适用

The Effect of Emotional Support Given During Cesarean Section on Pain, Anxiety, and Surgical Fear

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年7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
已完成
入组人数
120
试验地点
1
主要终点
Surgical Fear Scale

研究概览

简要总结

The study was conducted to determine the effect of emotional support given during cesarean section on pain, anxiety and surgical fear.

详细描述

The experimental study sample consisted of 120 women (emotional support group: 60, control group: 60). Data were collected using the Personal Information Form, Visual Analog Scale, State Anxiety Inventory and Surgical Fear Scale. In the comparison between the groups in the study, it was found that there was a statistically significant difference between the mean Visual Analog Scale scores of the women in the experimental and control groups in the pre-test (p<0.05), and no difference in the post-test (p˃0.05). In the post-test measured after emotional support, it was found that there was a statistically significant difference between the State Anxiety Inventory scores, short-term, long-term and total Surgical Fear Scale scores between the groups (p˂0.05). After emotional support, women's pain levels increased, anxiety and surgical fear levels decreased and their satisfaction with emotional support during birth increased. Women who did not receive emotional support had significantly increased pain, anxiety and surgical fear levels.

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
None

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Women who had a history of spinal anesthesia for the first time during a cesarean delivery,
  • •Who were going to have a planned cesarean before spontaneous contractions started,
  • •Who had no health problems with their babies,
  • •Who had no physical or mental problems themselves,
  • •Who had no communication difficulties,
  • •Women who volunteered to participate were included in the study.

排除标准

  • •Women who had a normal spontaneous delivery,
  • •Women who had a cesarean after labor/spontaneous contractions started,
  • •Women who had any health problems with their babies,
  • •Women who had a physical or mental illness themselves,
  • •Women who did not want to participate in the study were not included in the study.

研究组 & 干预措施

Providing emotional support during a caesarean section

Experimental

Empathetic approach, listening to the feelings and thoughts, welcoming the woman's behavior and expressions, telling her that she is breathing correctly, etc.), not judging the woman, being honest, using a soft and calm tone of voice, taking the baby or asking her opinion, encouraging her to endure the birth process, touching the woman and making physical contact, allowing her to practice her beliefs, showing the baby to the mother as soon as it is born and placing it in her arms.

干预措施: Emotional support group (Behavioral)

Standard of care Group

No Intervention

The control group did not receive any treatment. Only Visual Analog Scale, State Anxiety Inventory and Surgical Fear Scale were applied (pre-test, post-test)

结局指标

主要结局

Surgical Fear Scale

时间窗: Baseline

The Surgical Fear Scale, consisting of eight questions, is an 11-point Likert-type scale and is scored between 0 and 10. It consists of two sub-dimensions measuring short-term fears (items 1-4) and long-term fears (items 5-8) regarding the source of fear. The items in the scale are evaluated as "0: I am not afraid at all" and "10: I am very afraid". Increasing scores indicate increasing fear.

State Anxiety Inventory

时间窗: Baseline

The inventory consists of four-degree evaluations ranging from "Not at all" to "Completely" in the Likert type. There are 20 items in the inventory, and the individual is required to define how he/she feels at a certain moment and under certain conditions, and to respond by taking into account his/her feelings about the situation he/she is in. High scores indicate high anxiety levels, and low scores indicate low anxiety levels.

Visual Analog Scale

时间窗: Baseline

The scale is graded as 0-10 cm long, with 0=no pain, 10=the most severe pain. It is applied by the individual marking a point corresponding to the level of pain they feel. The distance between the determined point and the lowest part of the line is evaluated in centimeters. The value found indicates the patient's pain level.

次要结局

  • Surgical Fear Scale(through study completion, an average of 1 year)
  • State Anxiety Inventory(through study completion, an average of 1 year)
  • Visual Analog Scale(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sukran Ertekin Pinar

Assoc. Prof. Dr.

Cumhuriyet University

研究点 (1)

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