An interventional study of I COUGH care program in Dyspnea, Pain and Respiratory Insufficiency, sponsored by Yeditepe University. Completed at 3 sites in Libyan Arab Jamahiriya. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Yeditepe University · Not applicable, Interventional, and Supportive care
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.
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).
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 60 is above the median of 48 across 430 interventional studies indexed under Dyspnea.
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The control group participants underwent evaluations on the first day after 10 hours following surgery and, on the day, they were discharged from the clinic, by using pulse oximetry, sphygmometer, spirometry tests, VAS, MBDS and activity and mobility promotion (AMP). Participants in the control group were not given any information or training before or after the operation, and they were on routine hospital care.
The participants in the experimental group underwent the application of I COUGH (Incentive spirometry, Coughing/Deep breathing, Oral care, Understanding (Education of patient and family), Getting out of bed, and raising the Head of the bed). The participants underwent evaluations on the first day after 10 hours following surgery and, on the day, they were discharged from the clinic. Including Pulse Oximetry, Sphygmometer, Spirometry Tests, VAS, MBDS, AMP.
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.
Heart Rate (HR)
The number of heart beats per minute.
Time frame: 3 days of postoperatively
Systolic Blood pressure (SBP)
The minimum pressure recorded just prior to the next contraction.
Time frame: 3 days of postoperatively
Diastolic Blood pressure (DBP)
The maximum blood pressure during contraction of the ventricles.
Time frame: 3 days of postoperatively
Respiratory Rate (RR)
The number of breaths they take per minute.
Time frame: 3 days of postoperatively
Oxygen Saturation (SPO2)
A pulse oximeter reading that indicates what percentage of your blood is saturated.
Time frame: 3 days of postoperatively
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.
Time frame: 3 days of postoperatively
Pulmonary Function Test FVC
Noninvasive test that show how well the lungs are working, measuring of FVC
Time frame: 3 days of postoperatively
Pulmonary Function Test FEV
Noninvasive tests that show how well the lungs are working, measuring of FEV
Time frame: 3 days of postoperatively
Pulmonary Function Test FEV1/FVC
Noninvasive tests that show how well the lungs are working, measuring of FEV1/FVC
Time frame: 3 days of postoperatively
Pulmonary Function Test PEFR
Noninvasive tests that show how well the lungs are working, measuring of PEFR.
Time frame: 3 days of postoperatively
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.
Time frame: 3 days of postoperatively
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.
Time frame: 3 days of postoperatively
Plan to share: No
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