Cardiac Surgery PatientsNCT07730684
Teach-Back-Based Incentive Spirometry Training
A study testing routine care and Structured Teach-Back-Based Incentive Spirometry Training in people with Cardiac Surgery Patients and Breathing Exercises, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Patients, Breathing Exercises
- What is being tested?
- routine care and Structured Teach-Back-Based Incentive Spirometry Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Teach-Back-Based Structured Incentive Spirometry Training on Application Skill and Frequency in Cardiac Surgery Patients: A Randomized Controlled Study
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.
Read the detailed description
Cardiac surgery is associated with a risk of postoperative pulmonary complications due to factors such as anesthesia, surgical procedures, pain, and reduced respiratory function. Incentive spirometry is a commonly used breathing exercise technique to promote lung expansion and improve respiratory function after surgery. However, the effectiveness of incentive spirometry depends on patients' ability to perform the technique correctly and maintain regular practice.
The teach-back method is an educational approach in which patients are asked to explain or demonstrate the information they have received to confirm their understanding. This method may improve patients' knowledge, confidence, and self-management skills.
This study is designed to evaluate whether a structured incentive spirometry training program based on the teach-back method improves the correct performance and frequency of incentive spirometry use among patients undergoing cardiac surgery. The findings may contribute to the development of effective patient education strategies for improving postoperative respiratory care.
- Conditions
- Cardiac Surgery Patients, Breathing Exercises
- Being tested
- routine care, Structured Teach-Back-Based Incentive Spirometry Training
- Keywords
- teach back, patient education, Incentive spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine careOther
Participants will receive routine care without additional structured incentive spirometry education based on the teach-back method.
Structured Teach-Back-Based Incentive Spirometry TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants will receive routine postoperative care according to standard clinical practice. Receives: 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. Receives: Behavioral: Structured Teach-Back-Based Incentive Spirometry Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative Days 4-5
Secondary outcomes (2)
Daily Inspiratory Performance
Daily inspiratory performance will be assessed by the maximum number of balls elevated simultaneously during incentive spirometry use.
Measured: Postoperative Days 4 and 5.
Reasons for Not Performing Incentive Spirometry Exercises
Reasons for not performing incentive spirometry exercises will be recorded using patient self-reports during the postoperative period. Reported reasons (e.g., pain, fatigue, sleep, forgetfulness, or other factors) will be documented and analyzed descriptively.
Measured: Postoperative Days 4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start30 May 2025
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara ŞAHAN, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730684
- Sponsor's protocol ID
- E-76261397-050.04-733998
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Teach-Back-Based Structured Incentive Spirometry Training on Application Skill and Frequency in Cardiac Surgery Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07730684
- Acronym / sponsor ID
- E-76261397-050.04-733998
- Conditions
- Cardiac Surgery Patients, Breathing Exercises
- Keywords
- teach back, patient education, Incentive spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiac surgery is associated with a risk of postoperative pulmonary complications due to factors such as anesthesia, surgical procedures, pain, and reduced respiratory function. Incentive spirometry is a commonly used breathing exercise technique to promote lung expansion and improve respiratory function after surgery. However, the effectiveness of incentive spirometry depends on patients' ability to perform the technique correctly and maintain regular practice.
The teach-back method is an educational approach in which patients are asked to explain or demonstrate the information they have received to confirm their understanding. This method may improve patients' knowledge, confidence, and self-management skills.
This study is designed to evaluate whether a structured incentive spirometry training program based on the teach-back method improves the correct performance and frequency of incentive spirometry use among patients undergoing cardiac surgery. The findings may contribute to the development of effective patient education strategies for improving postoperative respiratory care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: routine careParticipants will receive routine postoperative care according to standard clinical practice. |
| Intervention Group | Experimental | Behavioral: Structured Teach-Back-Based Incentive Spirometry TrainingParticipants in the intervention group will receive structured incentive spirometry education based on the teach-back method in addition to routine postoperative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine careParticipants will receive routine care without additional structured incentive spirometry education based on the teach-back method. | Other | Control Group |
| Structured Teach-Back-Based Incentive Spirometry TrainingA 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. | Behavioural | Intervention Group |
Primary outcome
Correct Incentive Spirometry Performance
Time frame: Before the training intervention, immediately after the training intervention, and on postoperative Day 4.
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.
Frequency of Incentive Spirometry Use
Time frame: Postoperative Days 4-5
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.
2 secondary outcomes
Daily Inspiratory Performance
Time frame: Postoperative Days 4 and 5.
Reasons for Not Performing Incentive Spirometry Exercises
Time frame: Postoperative Days 4 and 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine care and Structured Teach-Back-Based Incentive Spirometry Training in people with Cardiac Surgery Patients and Breathing Exercises, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct Incentive Spirometry Performance (time frame: Before the training intervention, immediately after the training intervention, and on postoperative Day 4.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.