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

NCT06255327 | Completed DMC

• 1 other identifier: YTU.PT.TH.01/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Dyspnea; Pain; Respiratory Insufficiency; Mobility Limitation

Keywords

I COUGH; Dyspnea; Respiratory Parameters; Pain; Major Abdominal Surgery

Outcome Measures

Primary Outcomes (12)

• Heart Rate (HR)

  The number of heart beats per minute.

  3 days of postoperatively

• Systolic Blood pressure (SBP)

  The minimum pressure recorded just prior to the next contraction.

  3 days of postoperatively

• Diastolic Blood pressure (DBP)

  The maximum blood pressure during contraction of the ventricles.

  3 days of postoperatively

• Respiratory Rate (RR)

  The number of breaths they take per minute.

  3 days of postoperatively

• Oxygen Saturation (SPO2)

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

  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.

  3 days of postoperatively

• Pulmonary Function Test FVC

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

  3 days of postoperatively

• Pulmonary Function Test FEV

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

  3 days of postoperatively

• Pulmonary Function Test FEV1/FVC

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

  3 days of postoperatively

• Pulmonary Function Test PEFR

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

  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.

  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.

  3 days of postoperatively

Study Arms (2)

Control group

NO INTERVENTION

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 group

EXPERIMENTAL

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

Interventions

I COUGH care program OTHER

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.

Experimental group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (3)

AL-ASSEMA Hospital

Tripoli, 21821, Libya

Location

AL-KHALIL Hospital

Tripoli, 21821, Libya

Location

ROYAL Clinic

Tripoli, 21821, Libya

Location

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MeSH Terms

Conditions

Dyspnea; Pain; Respiratory Insufficiency; Mobility Limitation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Feras M Tana, MSc

  Yeditepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the control group were not given any information or training before or after the operation, and they were on routine hospital care.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: February 13, 2024
• Study Start: December 26, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 10, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

LI (3)