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临床试验/NCT07073482
NCT07073482已完成不适用

Evaluating the Role of Stress Ball Use in Reducing Anxiety and Pain and Promoting Breastfeeding Following Elective Cesarean Section

Samsun University1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
1
主要终点
Visual Anxiety Scale (VAS-A)

研究概览

简要总结

Although pregnancy and birth are physiological processes, they create a significant burden and stress for the female body. The pregnancy period can cause permanent psychological changes as well as physiological ones. In the pre-operative period, patients experience anxiety for many reasons. In addition to general concerns such as health and surgery-related concerns, uncertainty about the end, moving away from home and loved ones, and interruption of daily tasks, there are also anesthesia-related concerns such as not being able to wake up after surgery, feeling pain after surgery, and waking up during surgery. These concerns become even more severe during pregnancy. One of the factors that increases anxiety and depression in the post-natal period is the type of birth. Anxiety and depression may develop due to complications that may occur after a cesarean section, the possibility of a delay in breastfeeding the baby, and pain. Early detection of anxiety and depression and taking precautions are important in order to increase the mother's quality of life and comfort after a cesarean section and to reduce anxiety and worry. In studies conducted to reduce anxiety and depression after cesarean section, there are studies showing that non-pharmacological evidence-based practices such as reiki, acupressure, hand and foot massage, yoga, reflexology, aromatherapy, skin contact and nursing care protocol are effective. Another effective method for reducing anxiety and pain is the stress ball. A stress ball is a soft toy that is usually no larger than 7 cm, is worn on the hand and manipulated with the fingers to relieve stress and muscle tension or to work the muscles. The stress ball, which is one of the distraction methods, is an effective method for providing cognitive focus. It has been observed that the stress ball method is used to reduce patients' anxiety and pain. There is no study in the literature examining the effect of stress ball use on intraoperative and postoperative pain and anxiety in patients undergoing cesarean section and its effects on breastfeeding. For these reasons, our study will contribute to the literature.

详细描述

After a caesarean section, which is an abdominal surgery, gastrointestinal movements may slow down, nausea, vomiting, cramps, and respiratory dysfunction may occur due to manipulations during the surgery and opioid use. This may cause increased anxiety in women. Factors that cause increased anxiety in women after a caesarean section include being exposed to a surgical operation, as well as prolonged transition to oral feeding, late mobilization, increased risk of infection, and delayed mother-baby interaction and milk secretion. Pain, fatigue, anxiety, and depression experienced after birth may cause mothers to be reluctant to breastfeed and decrease milk production. Early detection of anxiety and depression that may occur after a caesarean section and taking precautions for these situations contribute to improving the mother's quality of life, reducing anxiety and worry, and maintaining an effective and efficient mother-baby relationship. We planned this study to examine the effects of stress ball application during caesarean surgery on patients' anxiety, pain, and breastfeeding.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •ASA 2 pregnant women

排除标准

  • •Those with known psychiatric or mental disorders, those using sedative medications, those under the age of 18 or over the age of 45, and those who do not want to be included in the study

结局指标

主要结局

Visual Anxiety Scale (VAS-A)

时间窗: postoperative 48 hours

It consists of a 10 cm long horizontal line. The left side contains the labels "No anxiety/worry" and the right side contains the labels "I am very anxious/worry". The VAS value is determined by measuring the distance between the top of the scale and the marked point. As the patient's anxiety level approaches 10, it shows that his anxiety increases.

State Trait Anxiety Inventory -STAI-II

时间窗: postoperative 48 hours

This scale consists of two parts: STAI-I and STAI-II. The scale consists of 20 items. Items 1-20 in the scale measure anxiety in four options. The statements in STAI-II are scored as; Almost never=1, Sometimes=2, Often=3, Almost always=4. The lowest score on the scale is 20, the highest score is 80. As the score increases, the anxiety level also increases.

次要结局

未报告次要终点

研究者

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

Hatice Kusderci

MD

Samsun University

研究点 (1)

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