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Completed

NCT Number: NCT06255327

Effectiveness of I COUGH 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.

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Key information

Conditions

Dyspnea Mobility Limitation Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AL-ASSEMA Hospital, Tripoli, Libya

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Heart Rate (HR)

    Time frame: 3 days of postoperatively

    The number of heart beats per minute.

  2. Systolic Blood pressure (SBP)

    Time frame: 3 days of postoperatively

    The minimum pressure recorded just prior to the next contraction.

  3. Diastolic Blood pressure (DBP)

    Time frame: 3 days of postoperatively

    The maximum blood pressure during contraction of the ventricles.

  4. Respiratory Rate (RR)

    Time frame: 3 days of postoperatively

    The number of breaths they take per minute.

  5. Oxygen Saturation (SPO2)

    Time frame: 3 days of postoperatively

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

  6. 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.

  7. Pulmonary Function Test FVC

    Time frame: 3 days of postoperatively

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

  8. Pulmonary Function Test FEV

    Time frame: 3 days of postoperatively

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

  9. 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

  10. Pulmonary Function Test PEFR

    Time frame: 3 days of postoperatively

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

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2024
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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