Effect of AI-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKocaeli University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective open heart surgery.
Conscious.
Speaks and understands Turkish.
Has a chest tube inserted (on the right and/or left side).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Rhythmic Breathing Group
Other interventionPatients 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) Group
Other interventionPatients 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.
Treatment groups
111 Participants
are divided into 3 treatment groupsGroup A: Rhythmic Breathing GroupExperimental treatment 1 intervention
Group B: Range of Motion-Deep Breathing (ROM-DN) GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Respiratory Rate
Measured continuously as breaths per minute while the patient is at rest.
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).2
Change in Oxygen Saturation (SpO2)
Measured as a percentage (%) using a noninvasive pulse oximeter
Time frame
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).3
Change in Heart Rate
Measured as beats per minute at rest using a noninvasive patient monitor.
Time frame
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).4
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.
Time frame
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).Secondary outcomes
1
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.
Time frame
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).2
Chest Tube Drainage Level
The fluid level change in the chest tube drainage system, measured in centimeters (cm).
Time frame
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).3
Presence of Chest Tube Tidaling
Observational evaluation of fluid movement (tidaling) in the drainage system, recorded categorically as "movement present" or "no movement".
Time frame
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)Sponsors and contacts
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Source ClinicalTrials.gov