Effectiveness of I COUGH Program to Dyspnea, Respiratory Parameters, Mobility and Pain After Major Abdominal Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06255327
• Other study ID #: YTU.PT.TH.01/2023
• Status: Completed
• Phase: N/A
• Start date: December 26, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: May 2024
• Source: Yeditepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspnea
• Mobility Limitation
• Pain
• Respiratory Insufficiency

Intervention

Other:
• I COUGH care program
The I COUGH program, initiated 10 hours after surgery, emphasizes the following elements: Incentive spirometry: Encouraging patients to use the Flow-IS device ten times every two hours for three days. Coughing and deep breathing: Participants should perform 3-5 coughs and deep breaths every 2 hours for 3 days. Oral care: Brushing teeth and using mouthwash twice daily between 8:00 a.m. and 8:00 p.m. Mouth brushes should be sterile, and non-alcoholic mouthwash is recommended. Understanding (education): Patients and their relatives receive instructions on the care program and steps to follow. Getting out of bed: Patients are encouraged to sit in a chair at least once and walk at least 3 times per day in the room and corridor with assistance as needed. Head-of-bed elevation: Keeping the head of the bed elevated more than 30 degrees.

Locations

Country	Name	City	State
Libyan Arab Jamahiriya	AL-ASSEMA Hospital	Tripoli
Libyan Arab Jamahiriya	AL-KHALIL Hospital	Tripoli
Libyan Arab Jamahiriya	ROYAL Clinic	Tripoli

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University

Country where clinical trial is conducted

Libyan Arab Jamahiriya, 

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate (HR)	The number of heart beats per minute.	3 days of postoperatively
Primary	Systolic Blood pressure (SBP)	The minimum pressure recorded just prior to the next contraction.	3 days of postoperatively
Primary	Diastolic Blood pressure (DBP)	The maximum blood pressure during contraction of the ventricles.	3 days of postoperatively
Primary	Respiratory Rate (RR)	The number of breaths they take per minute.	3 days of postoperatively
Primary	Oxygen Saturation (SPO2)	A pulse oximeter reading that indicates what percentage of your blood is saturated.	3 days of postoperatively
Primary	Modified Borg Dyspnea Scale (MBDS)	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.	3 days of postoperatively
Primary	Pulmonary Function Test FVC	Noninvasive test that show how well the lungs are working, measuring of FVC	3 days of postoperatively
Primary	Pulmonary Function Test FEV	Noninvasive tests that show how well the lungs are working, measuring of FEV	3 days of postoperatively
Primary	Pulmonary Function Test FEV1/FVC	Noninvasive tests that show how well the lungs are working, measuring of FEV1/FVC	3 days of postoperatively
Primary	Pulmonary Function Test PEFR	Noninvasive tests that show how well the lungs are working, measuring of PEFR.	3 days of postoperatively
Primary	Activity and Mobility Promotion (AMP)	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.	3 days of postoperatively
Primary	Visual Analogue Scale (VAS)	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.	3 days of postoperatively