- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07570420
Effect of a Preoperative Video Education Program on ICU Delirium After CABG (VIDEO-CABG Trial) (VIDEO-CABG)
The Effect of Preoperative Video-Based Educational Program on Patient's Incidence of ICU Delirium, Length of Stay, and Ambulation Post Coronary Artery Bypass Graft Surgery. A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the effect of a preoperative video-based educational program on postoperative outcomes in adult patients undergoing coronary artery bypass graft (CABG) surgery.
The main questions it aims to answer are:
Does the video-based educational program reduce the incidence of ICU delirium after CABG surgery? Does the program improve recovery outcomes, including length of ICU stay, hospital stay, and time to early ambulation?
Researchers will compare patients receiving the video-based educational program (intervention group) with those receiving standard care (control group) to determine whether the intervention improves postoperative outcomes.
Participants will:
Be randomly assigned to either the intervention or control group Receive either a structured preoperative video-based education program or standard verbal education Be assessed for ICU delirium using the CAM-ICU tool during ICU stay Have their length of ICU stay and hospital stay recorded from medical records Be monitored for early ambulation within the first 72 hours after surgery
Przegląd badań
Szczegółowy opis
This randomized controlled trial evaluates the effect of a structured preoperative video-based educational program on postoperative recovery outcomes in adult patients undergoing elective coronary artery bypass graft (CABG) surgery. Postoperative delirium remains a common complication after cardiac surgery and is associated with prolonged intensive care unit (ICU) and hospital stays, delayed recovery, and increased healthcare burden. In addition, delayed mobilization after surgery can further contribute to adverse outcomes.
Traditional preoperative education, typically delivered verbally or through written materials, may be insufficient for patients experiencing stress and anxiety prior to major surgery, leading to poor information retention. Video-based education offers a standardized, accessible, and engaging approach that may enhance patient understanding, improve adherence to recovery protocols, and support better clinical outcomes.
In this study, participants will be randomly assigned to receive either a brief preoperative video-based educational intervention or standard care. The intervention is designed to prepare patients for the postoperative period by providing clear, structured information on recovery expectations, delirium prevention strategies, and the importance of early mobilization.
The primary outcome of interest is the incidence of ICU delirium during the postoperative period. Secondary outcomes include length of ICU stay, length of hospital stay, and timing of early ambulation following surgery. These outcomes will be assessed using standardized clinical measures and hospital records.
By evaluating the effectiveness of a digital educational intervention in a cardiac surgery population, this study aims to contribute evidence on practical, scalable strategies to improve postoperative recovery and reduce complications in patients undergoing CABG surgery.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Amman Governorate
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Amman, Amman Governorate, Jordania, 11118
- University of Jordan
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria: Participants must meet all of the following criteria:
- Adult patients aged 18 years or older
- Scheduled for first-time, elective Coronary Artery Bypass Graft (CABG) surgery
- Able to read and understand Arabic
- Admitted preoperatively with sufficient time to receive the intervention (at least 24 hours before surgery)
Exclusion Criteria: Participants will be excluded if they meet any of the following criteria:
- Undergoing emergency or urgent CABG surgery
- Previous CABG (redo surgery)
- Cognitive impairment (e.g., diagnosed dementia, severe cognitive deficits, or Alzheimer's disease)
- Severe communication barriers (e.g., inability to understand Arabic, or severe hearing/visual impairment preventing comprehension of the educational video)
- Critical preoperative condition that prevents participation in the intervention
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Experimental - Video-Based Educational Program
Participants will receive a structured preoperative video-based educational program in addition to standard care. The intervention consists of a 5-10 minute video delivered one day before CABG surgery in Arabic. The video includes: Overview of CABG surgery and ICU environment Education on ICU delirium (definition, signs, and prevention) Explanation of the ABCDE delirium prevention bundle Instructions on early ambulation and breathing exercises Postoperative recovery expectations The video will be presented via tablet in a quiet setting, with a trained nurse available to clarify questions. Participants may replay the video if needed. |
The video includes: Overview of CABG surgery and ICU environment Education on ICU delirium (definition, signs, and prevention) Explanation of the ABCDE delirium prevention bundle Instructions on early ambulation and breathing exercises Postoperative recovery expectations |
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Brak interwencji: Active Comparator - Standard Care
Participants will receive routine preoperative education as provided in the hospital setting. This typically includes: Verbal instructions from nurses and healthcare staff Basic guidance on postoperative care (wound care, medications, activity restrictions, and warning signs) No structured or standardized video-based educational intervention will be provided. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Incidence of ICU Delirium
Ramy czasowe: Assessed twice daily (6 AM and 6 PM) during ICU stay, up to discharge from ICU. for three months
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Occurrence of postoperative delirium among patients admitted to the ICU following CABG surgery.
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Assessed twice daily (6 AM and 6 PM) during ICU stay, up to discharge from ICU. for three months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Length of ICU Stay
Ramy czasowe: From ICU admission post-surgery until transfer to ward. for three months
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Duration of time spent in the ICU after surgery.
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From ICU admission post-surgery until transfer to ward. for three months
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Length of Hospital Stay (LOS)
Ramy czasowe: From date of surgery until hospital discharge, expected average up to 30 days.
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Hospital length of stay will be calculated from the date and hour of the index CABG surgery until the date and hour of hospital discharge, expressed in days to one decimal place.
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From date of surgery until hospital discharge, expected average up to 30 days.
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Time to First Postoperative Ambulation Within 72 Hours After ICU Admission
Ramy czasowe: From ICU admission (postoperative day 0) through 72 hours after surgery.
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Time to first walk will be measured in hours from ICU admission after CABG surgery (T0) until the start of the first qualifying walking episode.
Transfers from bed to chair will not be counted as ambulation.
If no walking occurs within 72 hours, it will be recorded as "72+" with the clinical reason documented.
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From ICU admission (postoperative day 0) through 72 hours after surgery.
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Jafar A AL-SHRAIDEH, PROFESSOR, the university of Jordan
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- JU-NUR-2026-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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