Nursing CareNCT07665593
Effect of AI-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
A study testing Rhythmic Breathing Group and Range of Motion-Deep Breathing (ROM-DN) Group in people with Nursing Care and Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effect of artificial intelligence (AI)-assisted respiratory training on fatigue, pain, and respiratory parameters in patients after open heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing Care, Pain, Breathing Exercises
- What is being tested?
- Rhythmic Breathing Group and Range of Motion-Deep Breathing (ROM-DN) Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients undergoing elective open heart surgery.
- Conscious.
- Speaks and understands Turkish.
- Has a chest tube inserted (on the right and/or left side).
- No visual, auditory, or mental problems.
- Willing to participate in the study.
Who cannot join
- Undergoing concurrent other chest surgery or having a history of re-surgery.
- Development of early postoperative complications (e.g., atelectasis) within 0-3 days.
- Any loss of an extremity.
- Long-term immobilization and intubation.
- Development of severe post-surgery infections (such as mediastinitis or sepsis) or respiratory complications (such as pneumonia or atelectasis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University
Kocaeli, İzmit, 41380
Yaren Yurdakul, BSC, +090 553 495 85 21, yarenyurdakl@gmail.com
Yasemin Özhanlı, PHD
About this study
Official title: The Effect of Artificial Intelligence-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
This randomized controlled study aims to evaluate the effect of artificial intelligence (AI)-assisted respiratory training on fatigue, pain, and respiratory parameters in patients after open heart surgery.
Read the detailed description
Open heart surgery and related procedures (such as sternotomy, cardiopulmonary bypass, and chest tubes) can negatively affect pulmonary functions and cause postoperative pain, fatigue, and limited respiratory muscle function. While standard care involves respiratory exercises, there is insufficient data regarding the combination of upper extremity Range of Motion (ROM) exercises with deep breathing. This study will utilize AI-generated educational videos, created using tools like ChatGPT, Gemini, and Adobe Firefly, to guide patients in performing these exercises safely and correctly. Participants will be randomized into three groups: a Rhythmic Breathing group, a Range of Motion-Deep Breathing (ROM-DB) group, and a Control group. The interventions will be applied for three consecutive days. The study will evaluate outcomes including respiratory rate, oxygen saturation, heart rate, pain levels, fatigue, dyspnea, and chest tube drainage volume.
- Conditions
- Nursing Care, Pain, Breathing Exercises, Fatigue Recovery
- Being tested
- Rhythmic Breathing Group, Range of Motion-Deep Breathing (ROM-DN) Group
- Keywords
- pain, nursing care, fatigue, breathing exercises, open heart surgery
- Medical subject headings
- Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Breathing GroupOther
Patients in this group will watch an artificial intelligence-generated educational video on a tablet. Following the visual and auditory instructions in the video, they will perform a rhythmic breathing exercise consisting of inhaling for 3 seconds, holding the breath for 3 seconds, and exhaling for 3 seconds. The exercise will be performed for 5 repetitions, once a day, for 3 consecutive days under the supervision of the researcher.
Range of Motion-Deep Breathing (ROM-DN) GroupOther
Patients in this group will watch an artificial intelligence-generated educational video on a tablet. They will perform upper extremity range of motion (abduction and adduction) exercises synchronized with deep inspiration and expiration. This exercise will be performed for 5 repetitions, once a day, for 3 consecutive days under the supervision of the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic Breathing Group | Experimental | Patients will watch an AI-generated video via tablet and simultaneously perform a 3x3x3 rhythmic breathing exercise, which consists of inhaling for 3 seconds, holding the breath for 3 seconds, and exhaling for 3 seconds. The exercise will be repeated 5 times per session, once a day, for 3 days. Receives: Other: Rhythmic Breathing Group |
| Range of Motion-Deep Breathing (ROM-DN) Group | Experimental | Patients will watch an AI-generated video via tablet and simultaneously perform upper extremity Range of Motion (ROM) exercises combined with deep breathing. The exercise consists of 5 sets of controlled inspiration and expiration synchronized with arm abduction and adduction. This will be applied once a day for 3 days. Receives: Other: Range of Motion-Deep Breathing (ROM-DN) Group |
| Control Group | No intervention | Patients in this group will not receive the study-specific video exercises. They will be monitored under the clinic's standard routine care protocol, which includes standard breathing exercises and the use of an incentive spirometer (triflo). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Respiratory Rate
Measured continuously as breaths per minute while the patient is at rest.
Measured: Evaluated at baseline (before intervention), and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Change in Oxygen Saturation (SpO2)
Measured as a percentage (%) using a noninvasive pulse oximeter
Measured: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Change in Heart Rate
Measured as beats per minute at rest using a noninvasive patient monitor.
Measured: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Pain Level
Evaluated using the self-reported Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where "0" indicates no pain and "10" indicates unbearable pain. Higher scores mean a worse outcome.
Measured: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Fatigue Level
Evaluated using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where "0" indicates no fatigue and "10" indicates unbearable fatigue. Higher scores represent increased fatigue.
Measured: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Secondary outcomes (3)
Dyspnea Level
Evaluated using the Modified Borg Scale (CR-10), a category-ratio scale ranging from 0 (nothing at all) to 10. Higher scores indicate higher perceived exertion/dyspnea.
Measured: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Chest Tube Drainage Level
The fluid level change in the chest tube drainage system, measured in centimeters (cm).
Measured: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Presence of Chest Tube Tidaling
Observational evaluation of fluid movement (tidaling) in the drainage system, recorded categorically as "movement present" or "no movement".
Measured: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start10 Feb 2026
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaren Yurdakul, Kocaeli University
- Investigators
- Yaren Yurdakul, BSC, Principal investigator, Kocaeli UniversityYasemin Özhanlı, PHD, Study chair, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665593
- Sponsor's protocol ID
- 2026/02/33
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Artificial Intelligence-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT07665593
- Acronym / sponsor ID
- 2026/02/33
- Conditions
- Nursing Care, Pain, Breathing Exercises, Fatigue Recovery
- Keywords
- pain, nursing care, fatigue, breathing exercises, open heart surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Jun 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.
This randomized controlled study aims to evaluate the effect of artificial intelligence (AI)-assisted respiratory training on fatigue, pain, and respiratory parameters in patients after open heart surgery.
Detailed description
Open heart surgery and related procedures (such as sternotomy, cardiopulmonary bypass, and chest tubes) can negatively affect pulmonary functions and cause postoperative pain, fatigue, and limited respiratory muscle function. While standard care involves respiratory exercises, there is insufficient data regarding the combination of upper extremity Range of Motion (ROM) exercises with deep breathing. This study will utilize AI-generated educational videos, created using tools like ChatGPT, Gemini, and Adobe Firefly, to guide patients in performing these exercises safely and correctly. Participants will be randomized into three groups: a Rhythmic Breathing group, a Range of Motion-Deep Breathing (ROM-DB) group, and a Control group. The interventions will be applied for three consecutive days. The study will evaluate outcomes including respiratory rate, oxygen saturation, heart rate, pain levels, fatigue, dyspnea, and chest tube drainage volume.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rhythmic Breathing Group | Experimental | Other: Rhythmic Breathing GroupPatients will watch an AI-generated video via tablet and simultaneously perform a 3x3x3 rhythmic breathing exercise, which consists of inhaling for 3 seconds, holding the breath for 3 seconds, and exhaling for 3 seconds. The exercise will be repeated 5 times per session, once a day, for 3 days. |
| Range of Motion-Deep Breathing (ROM-DN) Group | Experimental | Other: Range of Motion-Deep Breathing (ROM-DN) GroupPatients will watch an AI-generated video via tablet and simultaneously perform upper extremity Range of Motion (ROM) exercises combined with deep breathing. The exercise consists of 5 sets of controlled inspiration and expiration synchronized with arm abduction and adduction. This will be applied once a day for 3 days. |
| Control Group | No intervention | –Patients in this group will not receive the study-specific video exercises. They will be monitored under the clinic's standard routine care protocol, which includes standard breathing exercises and the use of an incentive spirometer (triflo). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing elective open heart surgery.
- Conscious.
- Speaks and understands Turkish.
- Has a chest tube inserted (on the right and/or left side).
- No visual, auditory, or mental problems.
Key exclusion criteria (5 listed)
- Undergoing concurrent other chest surgery or having a history of re-surgery.
- Development of early postoperative complications (e.g., atelectasis) within 0-3 days.
- Any loss of an extremity.
- Long-term immobilization and intubation.
- Development of severe post-surgery infections (such as mediastinitis or sepsis) or respiratory complications (such as pneumonia or atelectasis).
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 |
|---|---|---|
| Rhythmic Breathing GroupPatients in this group will watch an artificial intelligence-generated educational video on a tablet. Following the visual and auditory instructions in the video, they will perform a rhythmic breathing exercise consisting of inhaling for 3 seconds, holding the breath for 3 seconds, and exhaling for 3 seconds. The exercise will be performed for 5 repetitions, once a day, for 3 consecutive days under the supervision of the researcher. | Other | Rhythmic Breathing Group |
| Range of Motion-Deep Breathing (ROM-DN) GroupPatients in this group will watch an artificial intelligence-generated educational video on a tablet. They will perform upper extremity range of motion (abduction and adduction) exercises synchronized with deep inspiration and expiration. This exercise will be performed for 5 repetitions, once a day, for 3 consecutive days under the supervision of the researcher. | Other | Range of Motion-Deep Breathing (ROM-DN) Group |
Primary outcome
Change in Respiratory Rate
Time frame: Evaluated at baseline (before intervention), and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Measured continuously as breaths per minute while the patient is at rest.
Change in Oxygen Saturation (SpO2)
Time frame: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Measured as a percentage (%) using a noninvasive pulse oximeter
Change in Heart Rate
Time frame: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Measured as beats per minute at rest using a noninvasive patient monitor.
Pain Level
Time frame: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Evaluated using the self-reported Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where "0" indicates no pain and "10" indicates unbearable pain. Higher scores mean a worse outcome.
Fatigue Level
Time frame: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Evaluated using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where "0" indicates no fatigue and "10" indicates unbearable fatigue. Higher scores represent increased fatigue.
3 secondary outcomes
Dyspnea Level
Time frame: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Chest Tube Drainage Level
Time frame: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
Presence of Chest Tube Tidaling
Time frame: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 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.
Yaren Yurdakul, BSC principal investigator
Kocaeli University
Yasemin Özhanlı, PHD study chair
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Breathing Group and Range of Motion-Deep Breathing (ROM-DN) Group in people with Nursing Care and Pain, run by Kocaeli 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaren Yurdakul, BSC (+090 553 495 85 21, yarenyurdakl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Respiratory Rate (time frame: Evaluated at baseline (before intervention), and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).). The study lists 5 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 24 Jun 2026.