- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07665593
Effect of AI-Assisted Respiratory Training on Pain, Fatigue and Respiratory Parameters in Patients After Open Heart Surgery
22. juni 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
111
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yaren Yurdakul, BSC
- Telefonnummer: +090 553 495 85 21
- E-mail: yarenyurdakl@gmail.com
Undersøgelse Kontakt Backup
- Navn: Yasemin Özhanlı, PHD
- Telefonnummer: (0262) 303 47 01
- E-mail: yaseminozhanli@gmail.com
Studiesteder
-
-
İzmit
-
Kocaeli, İzmit, Tyrkiet (Türkiye), 41380
- Rekruttering
- Kocaeli University
-
Kontakt:
- Yaren Yurdakul, BSC
- Telefonnummer: +090 553 495 85 21
- E-mail: yarenyurdakl@gmail.com
-
Kontakt:
- Yasemin Özhanlı, PHD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Ingen indgriben: 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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Respiratory Rate
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dyspnea Level
Tidsramme: 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
Tidsramme: 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).
|
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Presence of Chest Tube Tidaling
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Yaren Yurdakul, BSC, Kocaeli University
- Studiestol: Yasemin Özhanlı, PHD, Kocaeli University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. februar 2026
Primær færdiggørelse (Anslået)
1. august 2026
Studieafslutning (Anslået)
1. oktober 2026
Datoer for studieregistrering
Først indsendt
13. juni 2026
Først indsendt, der opfyldte QC-kriterier
22. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026/02/33
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