NCT07730684

Brief Summary

Patients undergoing cardiac surgery may experience difficulty performing breathing exercises after surgery, which can increase the risk of respiratory complications. Incentive spirometry is a breathing exercise technique commonly used to support lung function; however, patients may not always perform this exercise correctly or frequently enough. This study aims to evaluate the effect of a structured incentive spirometry education program based on the teach-back method on patients' ability to perform the exercise correctly and their frequency of use after cardiac surgery. This randomized controlled study will include 60 patients admitted for elective cardiac surgery at a university hospital in Türkiye. Participants will be randomly assigned to either a routine care group or an intervention group. Patients in the intervention group will receive structured incentive spirometry education using the teach-back method in addition to routine care, while the control group will receive routine care only. The ability to perform incentive spirometry correctly and the frequency of exercise use will be evaluated. The findings of this study may provide information about effective education strategies to improve postoperative breathing exercise practices in cardiac surgery patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 23, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

teach backpatient educationIncentive spirometry

Outcome Measures

Primary Outcomes (2)

  • Correct Incentive Spirometry Performance

    Correct incentive spirometry performance will be evaluated using an 11-item Incentive Spirometry Performance Checklist. Each item is scored on a 3-point scale (1 = not performed, 2 = partially performed, 3 = correctly performed), with total scores ranging from 11 to 33. Higher scores indicate better performance.

    Before the training intervention, immediately after the training intervention, and on postoperative Day 4.

  • Frequency of Incentive Spirometry Use

    Incentive spirometry use frequency will be assessed by recording the number of incentive spirometry exercises performed per hour during the postoperative period. The average number of incentive spirometry uses per recorded hour will be calculated.

    Postoperative Days 4-5

Secondary Outcomes (2)

  • Daily Inspiratory Performance

    Postoperative Days 4 and 5.

  • Reasons for Not Performing Incentive Spirometry Exercises

    Postoperative Days 4 and 5

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants will receive routine postoperative care according to standard clinical practice.

Other: routine care

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive structured incentive spirometry education based on the teach-back method in addition to routine postoperative care.

Behavioral: Structured Teach-Back-Based Incentive Spirometry Training

Interventions

Participants will receive routine care without additional structured incentive spirometry education based on the teach-back method.

Control Group

A structured teach-back-based incentive spirometry training program will be provided to patients undergoing cardiac surgery. The education aims to improve patients' ability to perform incentive spirometry correctly and increase the frequency of incentive spirometry use after surgery.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years and older.
  • Scheduled to undergo first-time elective open-heart surgery.
  • Hospitalized for at least 24 hours before surgery.
  • Able to read and understand Turkish.
  • Standardized Mini-Mental State Examination (SMMSE) score ≥24.

You may not qualify if:

  • Chronic respiratory disease.
  • Visual impairment that could interfere with incentive spirometry use.
  • Hearing impairment that could interfere with education or assessment.
  • Remaining in the intensive care unit on postoperative Days 4 and 5.
  • Postoperative disorientation during the ward stay.
  • No use of the incentive spirometer during the postoperative period.
  • Withdrawal of consent or unwillingness to continue participation after enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Aydın, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the intervention group receiving structured incentive spirometry education based on the teach-back method or the control group receiving routine care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 28, 2026

Study Start

May 30, 2025

Primary Completion

February 15, 2026

Study Completion

February 15, 2026

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations