Clinical trial NCT06255327: Effectiveness of I COUGH Program to Dyspnea, Respiratory Parameters, Mobility and Pain After Major Abdominal Surgery
Official title: The Effectiveness of The "I Cough" Care Program to Dyspnea, Respiratory Parameters, Mobility and Pain After Major Abdominal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Pain
Respiratory Insufficiency
Mobility Limitation
Keywords: I COUGH
Dyspnea
Respiratory Parameters
Pain
Major Abdominal Surgery
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The sample of the study (n=60) consisted of patients underwent major abdominal surgery required general anesthesia and hospital stay who got diagnosed by consultant general and bariatric surgery, being between 30-60 years old (39.9±8.82 years old; 47 F/ 13 M) volunteered to attend this study. The participants were randomly divided into two groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Heart Rate (HR)
timeFrame: 3 days of postoperatively
measure: Systolic Blood pressure (SBP)
timeFrame: 3 days of postoperatively
measure: Diastolic Blood pressure (DBP)
timeFrame: 3 days of postoperatively
measure: Respiratory Rate (RR)
timeFrame: 3 days of postoperatively
measure: Oxygen Saturation (SPO2)
timeFrame: 3 days of postoperatively
measure: Modified Borg Dyspnea Scale (MBDS)
timeFrame: 3 days of postoperatively
measure: Pulmonary Function Test FVC
timeFrame: 3 days of postoperatively
measure: Pulmonary Function Test FEV
timeFrame: 3 days of postoperatively
measure: Pulmonary Function Test FEV1/FVC
timeFrame: 3 days of postoperatively
measure: Pulmonary Function Test PEFR
timeFrame: 3 days of postoperatively
measure: Activity and Mobility Promotion (AMP)
timeFrame: 3 days of postoperatively
measure: Visual Analogue Scale (VAS)
timeFrame: 3 days of postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tripoli
country: Libyan Arab Jamahiriya
facility: AL-ASSEMA Hospital
city: Tripoli
country: Libyan Arab Jamahiriya
facility: AL-KHALIL Hospital
city: Tripoli
country: Libyan Arab Jamahiriya
facility: ROYAL Clinic
Study officials:
affiliation: Yeditepe University
name: Feras M Tana, MSc
role: PRINCIPAL_INVESTIGATOR
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