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临床试验/NCT06357429
NCT06357429已完成不适用

Evaluation of the Effect of Cold Application on the LI4 Point After Surgery on Acute Pain, Nausea and Anxiety Level

Saglik Bilimleri Universitesi2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2022年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Pain Level

研究概览

简要总结

It is an experimental study conducted to evaluate the effectiveness of cold application to the LI4 point of the hand to reduce/eliminate pain, nausea and anxiety in postoperative patients. The population of the study consisted of 116 individuals who underwent abdominal surgery with the open surgery method in a state hospital between February 2022 and November 2022 and were followed up in the inpatient ward. The study was completed with 80 individuals constituting the experimental group (n=40) and the control group (n=40). Patient information form, Mcgill Melzack short pain form, Visual Analog Scale, STAI - TX and Cold Application Evaluation Form were used to collect data. Patients in the experimental group underwent cold application with ice cubes for a total of 20 minutes as 2 minutes of cold application and 15 seconds of waiting 4-6 hours after the patient was admitted to the clinic after surgical intervention. Follow-up was performed before cold application, immediately after cold application, 30 minutes after the end of cold application, 1 hour and 2 hours after the end of cold application.

详细描述

It is a prospective study in which cold application is planned to reduce/eliminate the pain, nausea and anxiety experienced by patients after surgery. There are 2 different sample groups in the study. The first group consists of the experimental group in which cold application is planned to be applied to the hand LI4 point after surgical intervention and the control group in which routine interventions in the clinic are applied.

Hypotheses H1 The pain levels of individuals who received cold application to the LI4 point after surgery are lower than those who received routine care.

H2 Anxiety levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care.

H3 The nausea levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care.

Variables of the Study Independent Variables: Cold Application Dependent Variables: Socio-demographic characteristics, pain level, anxiety level, vital signs (body temperature, blood pressure, pulse, respiration), analgesic drug use, nausea level. The study was conducted in the inpatient wards of a state hospital.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Can speak and understand Turkish
  • Does not have any cognitive, affective and verbal problems that prevent them from communicating,
  • No postoperative complications (bleeding, infection, etc.),
  • Underwent surgery with general anesthesia,
  • Standardized analgesia protocol implemented,
  • Women without a physical hand or arm disability will be included.

排除标准

  • Those with chronic diseases such as diabetes, blood pressure, etc,
  • Allergic to cold,
  • Women with a certain period of intensive care (excluding postoperative care room) follow-up after surgery will not be included in the study

结局指标

主要结局

Pain Level

时间窗: 9 Months

Visual Analog Scale - There are numbers from 0 to 10 on the scale consisting of a 10 cm line used horizontally or vertically. The lowest number on the scale, 0, means "No Pain", 1-4 means "Mild Pain", 5-6 means "Moderate Pain" and 7-10 means "Intolerable Pain".

Nausea Level

时间窗: 9 Months

Visual Analog Scale - There are numbers from 0 to 10 on the scale consisting of a 10 cm line used horizontally or vertically. The lowest number on the scale, 0, indicates "No Nausea", 1-4 indicates "Mild Nausea", 5-6 indicates "Moderate Nausea" and 7-10 indicates "Intolerable Nausea".

Anxiety Level

时间窗: 9 Months

In the State Anxiety Scale, the answer options collected in four classes are (1) Never, (2) A little, (3) A lot and (4) Completely; the options in the Trait Anxiety Scale are (1) Almost never, (2) Sometimes, (3) Very often and (4) Almost always. There are two types of statements in the scales. These are (1) direct or straight statements and (2) reverse statements. Direct statements express negative emotions, while reversed statements express positive emotions. In direct statements, answers with a value of 4 indicate that anxiety is high. In reversed statements, answers with a value of 1 indicate high anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 on the state anxiety scale and items 21, 26, 27, 30, 33, 36 and 39 on the trait anxiety scale are inverted statements. The total score of both scales ranges between 20-80. An increase in the score indicates an increase in the level of anxiety.

Sensory characteristics, intensity and impact of pain

时间窗: 9 Months

The McGill Pain Scale Short Form consists of three parts. Section One: This section includes 15 descriptive word groups. Of these, 11 assess the sensory and 4 assess the perceptual dimension of pain. These descriptive words are rated on an intensity scale from 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. The sensory pain score was 0-33, the perceptual pain score was 0-12, and the total pain score was 0-45. An increase in the score indicates an increase in pain. Second Part: In the second part of the form, five word groups ranging from "mild pain" to "unbearable pain" were included to determine the severity of the patient's pain. Third Section: In the third part, the patient's current pain intensity was assessed using a visual comparison scale.

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

Ayşegül Alioğulları

PHD Student

Saglik Bilimleri Universitesi

研究点 (2)

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