- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07665593
Effect of AI-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
June 22, 2026 updated by: Yaren Yurdakul, Kocaeli University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
111
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yaren Yurdakul, BSC
- Phone Number: +090 553 495 85 21
- Email: yarenyurdakl@gmail.com
Study Contact Backup
- Name: Yasemin Özhanlı, PHD
- Phone Number: (0262) 303 47 01
- Email: yaseminozhanli@gmail.com
Study Locations
-
-
İzmit
-
Kocaeli, İzmit, Turkey (Türkiye), 41380
- Recruiting
- Kocaeli University
-
Contact:
- Yaren Yurdakul, BSC
- Phone Number: +090 553 495 85 21
- Email: yarenyurdakl@gmail.com
-
Contact:
- Yasemin Özhanlı, PHD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rhythmic Breathing Group
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.
|
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.
|
|
Experimental: Range of Motion-Deep Breathing (ROM-DN) Group
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.
|
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.
|
|
No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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
|
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
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.
|
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
|
|
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.
|
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
|
|
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.
|
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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.
|
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).
|
The fluid level change in the chest tube drainage system, measured in centimeters (cm).
|
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)
|
Observational evaluation of fluid movement (tidaling) in the drainage system, recorded categorically as "movement present" or "no movement".
|
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yaren Yurdakul, BSC, Kocaeli University
- Study Chair: Yasemin Özhanlı, PHD, Kocaeli University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
June 13, 2026
First Submitted That Met QC Criteria
June 22, 2026
First Posted (Actual)
June 24, 2026
Study Record Updates
Last Update Posted (Actual)
June 24, 2026
Last Update Submitted That Met QC Criteria
June 22, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/02/33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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