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- Klinische proef NCT07665593
Effect of AI-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
22 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
111
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Yaren Yurdakul, BSC
- Telefoonnummer: +090 553 495 85 21
- E-mail: yarenyurdakl@gmail.com
Studie Contact Back-up
- Naam: Yasemin Özhanlı, PHD
- Telefoonnummer: (0262) 303 47 01
- E-mail: yaseminozhanli@gmail.com
Studie Locaties
-
-
İzmit
-
Kocaeli, İzmit, Turkije (Türkiye), 41380
- Werving
- Kocaeli University
-
Contact:
- Yaren Yurdakul, BSC
- Telefoonnummer: +090 553 495 85 21
- E-mail: yarenyurdakl@gmail.com
-
Contact:
- Yasemin Özhanlı, PHD
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Respiratory Rate
Tijdsspanne: 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)
Tijdsspanne: 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).
|
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Change in Heart Rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Dyspnea Level
Tijdsspanne: 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).
|
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Chest Tube Drainage Level
Tijdsspanne: 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).
|
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
Tijdsspanne: 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)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Yaren Yurdakul, BSC, Kocaeli University
- Studie stoel: Yasemin Özhanlı, PHD, Kocaeli University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 februari 2026
Primaire voltooiing (Geschat)
1 augustus 2026
Studie voltooiing (Geschat)
1 oktober 2026
Studieregistratiedata
Eerst ingediend
13 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
22 juni 2026
Eerst geplaatst (Werkelijk)
24 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
22 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026/02/33
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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