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临床试验/NCT06342154
NCT06342154招募中不适用

Does Endorphin Massage Applied Before Cesarean Section Reduce the Anxiety of Pregnant Women?

Celal Bayar University2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2023年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
68
试验地点
2
主要终点
visual analog scale (VAS)

研究概览

简要总结

Before cesarean section surgery, researchers will demonstrate endorphin massage to the husbands of pregnant women, and they will be asked to apply the massage before the surgery. The stress levels and pain levels of women will be compared before and after the massage.

详细描述

The sample size of the research was calculated using G*Power 3.1.9.4 software as a minimum of 34 with 95% power, 0.01 alpha, and 0.9 effect size. The sample size was planned as experimental (n=34) and control (n=34) groups. To ensure the equality of the samples in both groups, a simple randomization method was used, where pregnant women with odd hospital protocol numbers will be included in the experimental group and those with even numbers will be included in the control group. Pregnant women who are admitted for pre-cesarean section care will be informed about the study, and their voluntary consent will be obtained both in written and verbal form. Pre-tests will be administered to both the experimental and control groups at 08:00, and blood samples will be taken to measure cortisol levels. Subsequently, an intervention will be applied to those in the experimental group, while those in the control group will receive routine nursing care. At 09:00, post-tests will be administered to both the experimental and control groups, and blood samples will be taken again to measure cortisol levels. The pre-test and post-test results, as well as the mean cortisol levels, will be compared between the experimental and control groups.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being admitted to the hospital for cesarean section
  • Being willing to participate in the research

排除标准

  • Having psychiatric illness
  • native language not Turkish

结局指标

主要结局

visual analog scale (VAS)

时间窗: one hour after intervention

VAS is preferred to convert some values that cannot be measured numerically into numerical values. VAS, which is a simple, effective, repeatable pain intensity measurement method that requires minimal tools, provides rapid measurement of pain intensity under clinical and laboratory conditions. There are studies in which VAS is used to evaluate pain in prenatal patients. In VAS, the patient is asked to make a mark on a 10 cm horizontal line that shows his current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates that the patient's pain is very good (0 = no pain), and the other end indicates that the patient's pain is very bad (10 = the most severe). The length of the distance from the point where there is no pain (0) to the point marked by the patient shows the patient's pain intensity.

State and Trait Anxiety Scales

时间窗: one hour after intervention

It is used to determine state and trait anxiety levels in individuals. State-Trait Anxiety Scale consists of a total of 40 items, 20 items each. The State Anxiety Scale requires the individual to describe how he or she feels at a particular moment and under certain circumstances. The total score of the scale varies between 20-80. A high score from the scale indicates a high level of anxiety, and a low score indicates a low level of anxiety.

cortisol level

时间窗: one hour after intervention

A high cortisol level indicates high stress, while a low level indicates low stress. Since cortisol levels follow a circadian rhythm, the timing of evaluation is crucial. Therefore, the first assessment in the study was conducted at 08:00, and the final evaluation was performed at 09:00.

次要结局

未报告次要终点

研究者

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

Yonca Çiçek Okuyan

Research Assistant

Celal Bayar University

研究点 (2)

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