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

May 2, 2024 updated by: Yeditepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Libyan Arab Jamahiriya
      • Tripoli, Libyan Arab Jamahiriya, 21821
        • AL-ASSEMA Hospital
      • Tripoli, Libyan Arab Jamahiriya, 21821
        • AL-KHALIL Hospital
      • Tripoli, Libyan Arab Jamahiriya, 21821
        • ROYAL Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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.
Experimental: Experimental group
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeditepe University

Investigators

  • Principal Investigator: Feras M Tana, MSc, Yeditepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2023

Primary Completion (Actual)

January 5, 2024

Study Completion (Actual)

January 10, 2024

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YTU.PT.TH.01/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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