跳至主要内容
临床试验/NCT06255327
NCT06255327已完成不适用

The Effectiveness of The "I Cough" Care Program to Dyspnea, Respiratory Parameters, Mobility and Pain After Major Abdominal Surgery.

Yeditepe University6 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年12月26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
60
试验地点
6
主要终点
Systolic Blood pressure (SBP)

研究概览

简要总结

The purpose of the current study was to investigate the effect of the I COUGH care program following major abdominal surgery dyspnea, oxygen saturation, pulmonary function, mobility, and pain after major abdominal surgery (MAS), participants were subjected to the "I COUGH" care program designed to support their health condition and reduce complications. The study aimed to investigate a simple and inexpensive pulmonary care program that can be easily understood and remembered by patients, their families, and medical staff.

Ho: The I COUGH care program after MAS does not improves pulmonary functions, oxygen saturation, mobility and decrease dyspnea and pain after MAS.

H1: The I COUGH care program improves pulmonary functions, oxygen saturation mobility and decrease dyspnea and pain after MAS.

详细描述

A total of 60 adult individuals aged between 30 and 60 years (mean age of 39.9±8.82) comprising 13 males and 47 females underwent major abdominal surgery requiring general anesthesia and hospitalization were invited to study. Patients were randomly assigned to either the Control Group (CG, n=30) or the Experimental Group (EG, n=30) using the block randomization method. Patients in the EG participated in the I COUGH care program included flow-incentive spirometer, oral care, coughing and breathing exercises, patient, and family education, getting out of bed, and elevating the head of the bed by more than 30 degrees for 3 days post-surgery. The patients in the CG did not undergo any interventions. All participants were assessed in terms of vital signs as heart rate, blood pressure, respiratory rate, and oxygen saturation. Moreover, dyspnea was assessed using the Modified Borg dyspnea Scale, pulmonary functions were evaluated using spirometry, mobility was assessed by Activity and Mobility Promotion scale and pain assessed Visual Analog Scale. Data were collected from all patients at baseline 10 h after the first day of surgery and on the day of discharge from the hospitals. The findings of the present study revealed that the I COUGH care program effectively improved pulmonary function and blood oxygenation, reduced the incidence of dyspnea, increased mobility, and decreased postoperative pain, with a statistically significant difference between the experimental and control groups (p<0.05).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants in the control group were not given any information or training before or after the operation, and they were on routine hospital care.

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the study.
  • Eligible patients are adults of both sexes between 30-60 years (Through the study, we are trying to reduce the variance and confounding factors that may arise from including patients who are less than 30 years old due to different stages of growth, physical abilities, hormonal levels, etc., or over 60 years old due to the prevalence of chronic diseases or diseases associated with aging).
  • Patients underwent elective abdominal surgery that required general anaesthesia and hospital stay e.g., Hernia repair, gall bladder removal, exploratory laparotomy, morbid obesity, ovarian cyst, Sigmoid diverticulitis, appendicitis, or other abdominal cavity procedures performed by laparoscopy and conventional laparotomy with a 5 cm or less incision above or extending above the umbilicus. (Incisions > 5cm may affect on possible results might be impacted in terms of: Increased risk of infection, risk of bleeding, pain, and discomfort during ambulation).

排除标准

  • The patient complains of an unstable heart rate or cardiac condition.
  • Symptomatic heart failure, unstable angina.
  • Pulmonary Hypertension
  • Unstable hypertension
  • The patient underwent organ transplants.
  • The patient presented an aneurysm of any arterial segment.
  • Serious condition or transferred to the intensive care unit after surgery.
  • Severe nephropathy.
  • A patient with cancer.
  • Cerebrovascular accident / Stroke.
  • Patient with balance or vestibular disorder.

结局指标

主要结局

Systolic Blood pressure (SBP)

时间窗: 3 days of postoperatively

The minimum pressure recorded just prior to the next contraction.

Heart Rate (HR)

时间窗: 3 days of postoperatively

The number of heart beats per minute.

Pulmonary Function Test FEV

时间窗: 3 days of postoperatively

Noninvasive tests that show how well the lungs are working, measuring of FEV

Pulmonary Function Test FEV1/FVC

时间窗: 3 days of postoperatively

Noninvasive tests that show how well the lungs are working, measuring of FEV1/FVC

Visual Analogue Scale (VAS)

时间窗: 3 days of postoperatively

This measure is based on self-reported symptoms and is recorded with a single mark placed along a 10-cm line, which represents a continuum between "no pain" on the left end (0 cm) and "worst pain" on the right end. to determine the intensity of pain and its enhancement when coughing in the postoperative area.

Modified Borg Dyspnea Scale (MBDS)

时间窗: 3 days of postoperatively

A valid and reliable tool to measure the intensity of dyspnea. It is a categorical scale with ratio properties, rating from 0 to 10, 0 being not dyspneic at all and 10 being maximally dyspneic.

Pulmonary Function Test FVC

时间窗: 3 days of postoperatively

Noninvasive test that show how well the lungs are working, measuring of FVC

Pulmonary Function Test PEFR

时间窗: 3 days of postoperatively

Noninvasive tests that show how well the lungs are working, measuring of PEFR.

Diastolic Blood pressure (DBP)

时间窗: 3 days of postoperatively

The maximum blood pressure during contraction of the ventricles.

Respiratory Rate (RR)

时间窗: 3 days of postoperatively

The number of breaths they take per minute.

Oxygen Saturation (SPO2)

时间窗: 3 days of postoperatively

A pulse oximeter reading that indicates what percentage of your blood is saturated.

Activity and Mobility Promotion (AMP)

时间窗: 3 days of postoperatively

AMP is based on measuring increasing patient mobility during hospital stay. The initial goals of this program included mobilization of each patient 3 times per day, documentation of patient mobility levels on the AMP scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验

Effectiveness of I COUGH Program to Dyspnea,... | 临床试验