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临床试验/NCT06415890
NCT06415890尚未招募不适用

The Effect of Usıng The 4-7-8 Breathıng Technıque on Postoperatıve Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholecystectomy

Mustafa Kemal University2 个研究点 分布在 2 个国家目标入组 98 人开始时间: 2024年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
98
试验地点
2
主要终点
Shoulder Pain

研究概览

简要总结

This study was planned as a randomized controlled clinical trial to determine the effect of 4-7-8 breathing technique on shoulder pain and pulmonary function tests after laporoscopic cholecystectomy. A sample of 96 patients will be randomly assigned to the study and control groups. The study group will be administered the 4-7-8 breathing technique after LK, while the control group will be given routine care of the ward. Shoulder pain and pulmonary function tests will be measured in the first 24 hours and at discharge. The data obtained will be analyzed by appropriate statistical methods.

详细描述

Laporoscopic cholecystectomy (LC) is the most commonly used method for the treatment of cholecystitis, one of the most common diseases of the digestive system. In addition to its advantages such as low risk of complications and usually requiring less than 24 hours of hospitalization, shoulder pain develops in approximately 35-80% of patients after LC. After LK, patients' lungs may be affected due to factors such as intraoperative general anesthesia, mechanical ventilation support, carbon dioxide (CO2) pneumoperitoneum administration, anesthetic drugs and patient positioning, and patients experience shoulder pain, especially with CO2 pneumoperitoneum administration. In patients undergoing LK, shoulder pain felt throughout the thorax causes spasm and restriction of movement in the muscles assisting respiration and an increase in intercostal tone. This leads to a decrease in the amount of air filling the lungs, accumulation of secretions, pneumonia, decreased functional residual volume and increased risk of atelectasis. For this reason, it is necessary to evaluate the respiratory system in patients undergoing LK as in all surgical interventions and to monitor pulmonary functions (FVC, FEV1, FEV1/FCV) to evaluate the deterioration in lung functions and to control pain with pharmacologic and non-pharmacologic methods. One of the respiratory exercises that nurses can apply independently in the removal of CO₂, improvement of respiratory functions and pain control after surgery is the 4-7-8 breathing technique. This technique has been proven to have positive contributions in pain control, and its easy application, reliability and non-invasiveness make its use widespread.

This study was planned as a randomized controlled clinical trial to determine the effect of 4-7-8 breathing technique on shoulder pain and pulmonary function tests after LK. A sample of 96 patients will be randomly assigned to the study and control groups. The study group will be administered the 4-7-8 breathing technique after LK, while the control group will be given routine care of the ward. Shoulder pain and pulmonary function tests will be measured in the first 24 hours and at discharge. The data obtained will be analyzed by appropriate statistical methods.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The information that the patients included in the research sample were assigned to groups A and B according to the randomization table will be kept by the consultant, the researcher will fill out the "Informed Consent Form" for all patients when he/she goes to the patient for the application, and then the consultant will share the information about which group the patient is in with the researcher. When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups and the data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will be blinded to group assignment.

入排标准

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

入选标准

  • Undergoing elective laparoscopic cholecystectomy,
  • Admitted to the clinic at least 2 hours before the surgical procedure,
  • Open to communication and cooperation,
  • Written and verbal permission to participate in the study was obtained,
  • Conscious, oriented and cooperative,
  • No cognitive and mental problems,
  • Speaks and understands Turkish,
  • American Society of Anesthesiologists (ASA) classification scores of I and II,
  • Hospitalized at least one night after surgical intervention,
  • Patients aged 18 years and older will be included in the study.

排除标准

  • Undergoing emergency laparoscopic cholecystectomy,
  • Open cholecystectomy,
  • Not admitted to the clinic at least 2 hours before the surgical procedure,
  • Not open to communication and cooperation,
  • Written and verbal permission to participate in the research could not be obtained,
  • Unconscious, disoriented and uncooperative,
  • Cognitively and mentally impaired,
  • Speaking Turkish but not understanding it,
  • Discharged on the same day after surgical intervention,
  • ASA score III and above,
  • Patients aged 18 years and younger will not be included in the study.

结局指标

主要结局

Shoulder Pain

时间窗: Second postoperative day

Visual Analog Scale (VAS):The VAS used in this study is a one-dimensional pain scale commonly used in adult populations. The VAS is a continuous scale consisting of a horizontal or vertical line 10 centimeters (100 mm) long. Pain intensity is determined by statements ranging from "no pain" at one end of the scale to "excruciating pain" at the other end. The participant is asked to place a line perpendicular to the VAS line at the point representing pain intensity. Pain scoring is determined by measuring the distance (mm) on the 10-centimeter line using a ruler and is defined by providing a score range between 0-100 mm (No pain=0-4 mm, mild pain=5-44 mm, moderate pain=45-74 mm and severe pain=75-100 mm). In this study, the vertical form of the VAS will be used to evaluate shoulder pain in patients after surgical intervention based on the information that the vertical form of the VAS gives more accurate results than the horizontal form Translated with DeepL.com (free version)

Pulmonary Function Test

时间窗: Second postoperative day

Pulmonary Function Test: Pulmonary function values will be evaluated with a portable . FVC (%), FEV1 (%) and FEV1/FVC (%) parameters will be used in the evaluationpulmonary function test device.

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

Ayse Nur Serbest Baz

Lecturer

Mustafa Kemal University

研究点 (2)

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