- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07665593
Effect of AI-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
22 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
111
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Yaren Yurdakul, BSC
- Telefonnummer: +090 553 495 85 21
- E-post: yarenyurdakl@gmail.com
Studera Kontakt Backup
- Namn: Yasemin Özhanlı, PHD
- Telefonnummer: (0262) 303 47 01
- E-post: yaseminozhanli@gmail.com
Studieorter
-
-
İzmit
-
Kocaeli, İzmit, Turkiet (Türkiye), 41380
- Rekrytering
- Kocaeli University
-
Kontakt:
- Yaren Yurdakul, BSC
- Telefonnummer: +090 553 495 85 21
- E-post: yarenyurdakl@gmail.com
-
Kontakt:
- Yasemin Özhanlı, PHD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
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Inget ingripande: 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).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Respiratory Rate
Tidsram: 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).
|
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Change in Oxygen Saturation (SpO2)
Tidsram: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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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).
|
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Change in Heart Rate
Tidsram: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Measured as beats per minute at rest using a noninvasive patient monitor.
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Pain Level
Tidsram: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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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.
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
|
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Fatigue Level
Tidsram: 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.
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dyspnea Level
Tidsram: 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.
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Chest Tube Drainage Level
Tidsram: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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The fluid level change in the chest tube drainage system, measured in centimeters (cm).
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session).
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Presence of Chest Tube Tidaling
Tidsram: Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)
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Observational evaluation of fluid movement (tidaling) in the drainage system, recorded categorically as "movement present" or "no movement".
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Evaluated at baseline, and Day 1, Day 2, and Day 3 (measured both before and 5 minutes after the exercise session)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Yaren Yurdakul, BSC, Kocaeli University
- Studiestol: Yasemin Özhanlı, PHD, Kocaeli University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 februari 2026
Primärt slutförande (Beräknad)
1 augusti 2026
Avslutad studie (Beräknad)
1 oktober 2026
Studieregistreringsdatum
Först inskickad
13 juni 2026
Först inskickad som uppfyllde QC-kriterierna
22 juni 2026
Första postat (Faktisk)
24 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026/02/33
Plan för individuella deltagardata (IPD)
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