Effect of AI-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
The Effect of Artificial Intelligence-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
1 other identifier
interventional
111
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
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
February 10, 2026
CompletedFirst Submitted
Initial submission to the registry
June 13, 2026
CompletedFirst Posted
Study publicly available on registry
June 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedJune 24, 2026
June 1, 2026
6 months
June 13, 2026
June 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in Respiratory Rate
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)
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
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
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
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 Outcomes (3)
Dyspnea Level
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
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
Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)
Study Arms (3)
Rhythmic Breathing Group
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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 INTERVENTIONPatients 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kocaeli University
Kocaeli, İzmit, 41380, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaren Yurdakul, BSC
Kocaeli University
- STUDY CHAIR
Yasemin Özhanlı, PHD
Kocaeli University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse
Study Record Dates
First Submitted
June 13, 2026
First Posted
June 24, 2026
Study Start
February 10, 2026
Primary Completion
August 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
June 24, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share