Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery.

NCT07405333 | Recruiting DMC

• 1 other identifier: UOB-NUR-2026-01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 4

Brief Summary

This study examines the effects of coughing exercises and incentive spirometry (IS) on lung function and recovery in children who undergo heart surgery. The main goals are to see: How coughing exercises and IS affect breathing and lung function after surgery? How these exercises influence overall recovery after surgery? Children who participate will be randomly assigned to one of three groups: coughing exercises, IS, or standard care. Those in the exercise groups will perform their assigned breathing exercises every 3 hours for the first 3 days after surgery. Daily check-ups will be conducted to monitor their progress, lung function, and oxygen levels. The study will measure breathing ability, oxygen levels, and recovery milestones to find out which method is most effective in preventing lung complications and helping children recover faster.

Conditions

Postoperative Respiratory Dysfunction; Congenital Heart Disease (CHD); Postoperative Recovery After Cardiac Surgery

Keywords

Coughing Exercises; Incentive Spirometry; Congenital Heart Disease; Respiratory Function; Recovery; cardiac surgery; pediatric

Outcome Measures

Primary Outcomes (1)

• Respiratory Function Score.

  A composite postoperative respiratory function score assessed using standardized pediatric respiratory severity score, including respiratory rate (breaths/min), oxygen saturation measured by pulse oximetry (SpO₂, %), presence of wheezing (yes/no), use of accessory respiratory muscles (yes/no), and feeding tolerance. Higher scores indicate better respiratory function.

  Baseline, 1 hour after intervention, 3 hours, 6 hours, 24 hours, 48 hours, and 72 hours.

Secondary Outcomes (4)

• Postoperative Recovery Indicators Assessed by Clinical and Functional Parameters

  Baseline, postoperative day 1, and postoperative day 7

• Length of Intensive Care Unit (ICU) Stay

  From ICU admission after surgery until ICU discharge, up to postoperative day 14

• Arterial Blood Gas (ABG) Parameters

  Baseline (prior to intervention) and 24, and 48 hours after intervention

• postoperative complications

  From the first postoperative day until hospital discharge (up to 7 postoperative days).

Study Arms (3)

Coughing Exercises

EXPERIMENTAL

participants in this arm will receive structured postoperative coughing exercises under professional supervision. The exercises include deep breathing followed by effective coughing techniques to enhance airway clearance, promote lung expansion, and prevent postoperative pulmonary complications. The intervention will be performed every 3 hours for three days after cardiac surgery in addition to standard postoperative care.

Behavioral: Coughing Exercises

Incentive Spirometry (IS)

EXPERIMENTAL

Participants in this arm will receive postoperative incentive spirometry under professional supervision. Children will be instructed to perform slow, deep inhalations using an incentive spirometer to promote lung expansion, improve ventilation. The intervention will be performed 15 times every 3 hours for three days after cardiac surgery in addition to standard postoperative care.

Device: Incentive Spirometry

Standard Postoperative Care

ACTIVE COMPARATOR

Participants in this arm will receive standard postoperative care following cardiac surgery without additional structured respiratory physiotherapy interventions. Standard care includes routine medical and nursing management according to hospital protocols, such as oxygen therapy, pain management, monitoring of vital signs, and general postoperative mobilization as tolerated.

Other: Standard Postoperative Care

Interventions

Coughing Exercises BEHAVIORAL

participants will receive structured postoperative coughing exercises supervised by trained healthcare professionals. The intervention includes instruction on effective deep breathing followed by directed coughing to enhance airway clearance and prevent secretion retention. Exercises will be performed every 3 hours for three consecutive days after cardiac surgery, in addition to standard postoperative care.

Coughing Exercises

Incentive Spirometry DEVICE

participants will perform postoperative incentive spirometry using a standard incentive spirometer under professional supervision. Children will be instructed to perform slow, deep inspirations with visual feedback to promote lung expansion and alveolar recruitment. The intervention will be conducted 15 times every 3 hours for three days after surgery, alongside standard postoperative care.

Incentive Spirometry (IS)

Standard Postoperative Care OTHER

Participants will receive routine postoperative care according to institutional protocols following cardiac surgery. This includes standard medical and nursing management such as oxygen therapy, pain control, monitoring of vital signs, and mobilization as tolerated, without additional structured respiratory physiotherapy interventions.

Standard Postoperative Care

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Pre-existing moderate-to-severe chronic lung disease requiring baseline oxygen therapy.
• Neuromuscular disorders significantly impairing cough/inspiratory effort.
• Emergency surgery, ongoing major bleeding.
• Prolonged mechanical ventilation \>72 hours or tracheostomy on admission.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (4)

Ibn Al-Bitar Specialized Hospital for Cardiac Surgery

Baghdad, Baghdad Governorate, Iraq

RECRUITING

Ibn Al-Nafis Hospital for Cardiac, Thoracic and Vascular Surgery

Baghdad, Baghdad Governorate, Iraq

RECRUITING

Iraqi Center for Heart Diseases

Baghdad, Baghdad Governorate, Iraq

RECRUITING

Imam Al-Hassan Al-Mujtaba Hospital

Karbala, Karbala Governorate, Iraq

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

rusul khalid khadim, MSc

CONTACT

96407702612183; rusal.khaled1606a@conursing.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student / Principal Investigator

Model Details: this is a parallel-assignment randomized interventional study with three arms: coughing exercises, incentive spirometry, and standard care. Participants will remain in their assigned group throughout the study period, receiving the allocated intervention along with standard postoperative care

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 12, 2026
• Study Start: December 7, 2025
• Primary Completion (Estimated): August 7, 2026
• Study Completion (Estimated): October 7, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (4)