NCT07570420

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 20, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

ICU DeliriumVideo-Based EducationPreoperative EducationEarly AmbulationLength of Stay

Outcome Measures

Primary Outcomes (1)

  • Incidence of ICU Delirium

    Occurrence of postoperative delirium among patients admitted to the ICU following CABG surgery.

    Assessed twice daily (6 AM and 6 PM) during ICU stay, up to discharge from ICU. for three months

Secondary Outcomes (3)

  • Length of ICU Stay

    From ICU admission post-surgery until transfer to ward. for three months

  • Length of Hospital Stay (LOS)

    From date of surgery until hospital discharge, expected average up to 30 days.

  • Time to First Postoperative Ambulation Within 72 Hours After ICU Admission

    From ICU admission (postoperative day 0) through 72 hours after surgery.

Study Arms (2)

Experimental - Video-Based Educational Program

EXPERIMENTAL

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.

Behavioral: Video-Based Educational Program

Active Comparator - Standard Care

NO INTERVENTION

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.

Interventions

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

Experimental - Video-Based Educational Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan

Amman, Amman Governorate, 11118, Jordan

Location

Study Officials

  • Jafar A AL-SHRAIDEH, PROFESSOR

    The University of Jordan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
This study is conducted as an open-label randomized controlled trial; therefore, participants and care providers are not blinded due to the nature of the intervention (video-based education). However, to reduce bias: Outcome assessors (ICU nurses) responsible for evaluating delirium using the CAM-ICU will be blinded to group allocation whenever feasible.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a two-arm, parallel-group randomized controlled trial. Eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group (video-based educational program) or the control group (standard care). Randomization will be conducted using a computer-generated block randomization method with variable block sizes to ensure balanced group allocation. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared by an independent statistician. Participants in the experimental group will receive a structured preoperative video-based educational intervention in addition to standard care, while participants in the control group will receive standard care only. Outcomes will be assessed postoperatively, with the incidence of ICU delirium as the primary outcome, and early ambulation, ICU length of stay, and hospital length of stay as secondary outcomes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. School of Nursing, The University of Jordan

Study Record Dates

First Submitted

April 20, 2026

First Posted

May 6, 2026

Study Start

January 3, 2026

Primary Completion

April 10, 2026

Study Completion

April 17, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified data will be uploaded to selected repository

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
3 months after completion
Access Criteria
on request

Locations