Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609483364112 Date of Registration: 08/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title AI-Supported Video-Based Perioperative Education for Adults Undergoing Cancer Surgery in Egypt
Official scientific title Artificial Intelligence Supported Video-Based Perioperative Nursing Education for Patients Undergoing Cancer Surgery: An Assessor-Blinded Randomized Controlled Trial in Egypt** |
Brief summary describing the background and objectives of the trial Patients undergoing cancer surgery commonly experience preoperative anxiety and may have unmet information needs regarding surgical preparation, anesthesia, postoperative recovery, wound and drain care, mobilization, and discharge safety. Structured video-based education may provide standardized, understandable, and accessible perioperative information while supporting nursing communication. This assessor-blinded randomized controlled trial evaluates AI-OncoPrep Egypt, a clinician-approved, nurse-facilitated, AI-supported video-based perioperative nursing education program for adults undergoing elective cancer surgery in Egypt. The intervention comprises six short Arabic educational videos delivered across the perioperative pathway, covering emotional preparation, pre-admission preparation, surgery and anesthesia safety, early postoperative recovery, wound and drain care, nutrition and mobilization, and discharge safety. Artificial intelligence is used only to support content simplification, captioning, audiovisual production, and non-clinical engagement functions; it does not diagnose, triage, prescribe, or provide individualized clinical advice. The trial evaluates whether adding the standardized video education program to routine perioperative care improves patient knowledge and psychological and postoperative outcomes compared with routine perioperative education alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AI-OncoPrep Egypt
Disease(s) or condition(s) being studied Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/08/2026
Actual trial start date 03/08/2026
Anticipated date of last follow up 31/10/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group AI Supported Video Based Perioperative Nursing Education Participants received six standardized Arabic perioperative education videos delivered across the surgical pathway. Videos 1–3 were delivered preoperatively, Video 4 during the early postoperative period when the patient was clinically stable, and Videos 5–6 before discharge. Total standardized exposure was approximately 18–22 minutes. From the preoperative period through hospital discharge, with 30-day postoperative follow-up for outcome assessment. AI-OncoPrep Egypt is a clinician-approved, nurse-facilitated, AI-supported video-based perioperative nursing education program for adults undergoing elective cancer surgery. The intervention consists of six short Arabic educational videos covering: (1) orientation and emotional preparation; (2) safe preparation before surgery; (3) the day of surgery, anesthesia safety, and coping with anxiety; (4) early postoperative recovery, including pain, breathing, and mobilization; (5) wound and drain care, nutrition, and activity; and (6) discharge safety, medicines, follow-up, and warning signs. The program supplements routine perioperative education and does not replace individualized medical, surgical, anesthesia, or nursing instructions. Artificial intelligence is used only to support content simplification, caption generation, audiovisual production, and non-clinical engagement functions. It does not diagnose, triage, prescribe, modify fasting or medication instructions, or provide individualized clinical advice. A trained oncology/surgical nurse facilitates access, reinforces that local clinical instructions take priority, and documents intervention delivery and fidelity. 150
Control Group Routine perioperative education and usual care Routine perioperative education and usual clinical care were provided according to the participating unit’s standard practice throughout the perioperative period. From the preoperative period through hospital discharge, with 30-day postoperative follow-up for outcome assessment. Participants allocated to the control group received the participating unit’s usual perioperative education and routine clinical care. They did not receive access to the AI-OncoPrep Egypt video education program during the trial intervention period. The control condition included standard verbal and written perioperative education delivered according to routine practice. If permitted by the ethics committee, the educational video program may be offered after completion of final follow-up. 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged 18 years or older. Patients with a confirmed cancer diagnosis who are scheduled for elective cancer surgery. Patients who provide written informed consent to participate in the study. Patients who are clinically able to participate in perioperative education and study assessments. Patients undergoing emergency rather than elective cancer surgery. Patients who were clinically unstable or unable to participate in the educational intervention or study assessments. Patients with severe cognitive impairment that prevented informed consent or reliable completion of study assessments. Patients with severe uncorrected visual or hearing impairment that prevented engagement with the video intervention despite reasonable assistance. Patients who were unable to communicate sufficiently in Arabic to understand the educational content and complete the study assessments. Patients who declined or withdrew informed consent. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/05/2026 Research Ethics Committee Faculty of Nursing Helwan University
Ethics Committee Address
Street address City Postal code Country
Faculty of Nursing, Helwan University Campus, Ain Helwan, Cairo Cairo 11795 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in preoperative anxiety and information need, measured using the validated Arabic Amsterdam Preoperative Anxiety and Information Scale (APAIS). Higher scores indicate greater anxiety and information need. Baseline before the educational intervention and immediately after completion of the assigned perioperative education, before surgery.
Secondary Outcome Change in surgical preparation knowledge, measured using the Oncology Surgical Preparation Knowledge Questionnaire, including knowledge of fasting, medications, investigations, pain management, breathing exercises, early mobilization, wound care, warning signs, and discharge preparation. Baseline before education and immediately after completion of the educational intervention.
Secondary Outcome Adherence to preoperative instructions, assessed using a structured nurse/researcher checklist covering fasting, medication, investigations, documents, and preparation instructions. On the day of surgery before transfer to the operating room.
Secondary Outcome Patient satisfaction and usability of perioperative education, assessed using a structured questionnaire evaluating clarity, usefulness, trust, cultural appropriateness, reassurance, preparedness, and acceptability. Immediately after education or before hospital discharge.
Secondary Outcome Early postoperative quality of recovery, assessed using the Arabic Quality of Recovery-15 (QoR-15). 24 to 48 hours after surgery.
Secondary Outcome Postoperative pain intensity, measured using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain). 24 hours, 48 hours, and at discharge.
Secondary Outcome Postoperative clinical outcomes, including length of hospital stay, postoperative complications, surgical-site infection, unplanned ICU admission, emergency visits, unplanned hospital contact, and readmission. During hospitalization, at discharge, and at 30-day postoperative follow-up.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr AlAini hospital Kasr AlAini Cairo Egypt Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ehsan Ahmed Yahia Othman Sharkawy 18 Alzaitoun station Cairo 11351 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ehsan Ahmed Yahia 18 alzaitoun Cairo 11351 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ehsan Ahmed Yahia ehsanyahia@cu.edu.eg 00201004349112 18 A Alzaitoun
City Postal code Country Position/Affiliation
Cairo 11351 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Hanan Saber ehsanyahia@cu.edu.eg 00201004349112 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Ehsan Yahia ehsanyahia78@gmail.com 00201004349112 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant profesor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in the main trial publication may be made available upon reasonable request to the corresponding author, subject to ethical approval, institutional requirements, and protection of participant confidentiality. No directly identifying information will be shared. Study Protocol Data may be considered for sharing after publication of the primary trial results and for a reasonable period thereafter, subject to applicable ethical and institutional requirements. De-identified data may be provided to qualified researchers upon reasonable written request to the corresponding author. Requests should include a scientifically justified research question, a brief analysis plan, and confirmation that participant confidentiality will be protected. Access will be subject to applicable ethical and institutional approval and any required data-use agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information