- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07701564
Motion Graphic Training for Scrub Nurses in Hip Surgery
Motion Graphic Video-Based Training and Its Effect on Scrub Nurse Performance During Dynamic Hip Screw Surgery in Iran: A Pilot Randomized Controlled Trial
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This is a pilot randomized controlled trial conducted at Valiasr Teaching Hospital, Arak University of Medical Sciences, Iran, from December 2024 to July 2025. The study is designed according to CONSORT guidelines for pilot and feasibility trials.
A total of 30 undergraduate operating room technology students in their 6th or 8th semester are randomly assigned to intervention (n=15) and control (n=15) groups using block randomization with a computer-generated random numbers table. Both groups receive routine clinical training from the same instructor at the beginning of the course. The intervention group additionally views a 15-minute motion graphic video demonstrating DHS surgical steps, which they can watch unlimited times during the 15-day internship period. The video content includes introduction of surgical instruments, anatomy review, surgical table setup, patient preparation and draping, and instrument delivery to the surgeon.
Students' performance as first scrub nurse is assessed twice: on the first day of internship (pre-test) and at the end of the 15-day internship (post-test) by a blinded independent evaluator using a validated 43-item checklist covering preoperative (13 items), intraoperative (24 items), and postoperative (6 items) phases. The checklist has been validated for content validity and reliability through expert review and pilot testing.
To prevent contamination, the control group is enrolled first, and intervention group students are asked not to discuss the educational video with others. The video will be provided to the control group after study completion for educational equity.
Data will be analyzed using paired and independent t-tests. Effect sizes will be calculated for between-group comparisons.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Arak, Írán
- Hamed
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Undergraduate operating room technology student in the 6th or 8th semester
- Completion of the theoretical course in orthopedic operating room technology and care
- Willingness to participate and provide informed consent
Exclusion Criteria:
Withdrawal or unwillingness to continue participation at any stage
- Previous clinical experience in orthopedics that could affect the results
- Absenteeism or insufficient presence during the internship
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Motion Graphic Video Training
Students received a 15-minute motion graphic video demonstrating DHS surgical steps, in addition to routine clinical training, with unlimited access during the 15-day internship.
|
A 15-minute animated video demonstrating the steps of proximal femur fracture surgery using a dynamic hip screw (DHS).
Content includes surgical instruments, anatomy review, table setup, patient draping, and instrument delivery to the surgeon.
|
|
Aktivní komparátor: Routine Clinical Training
Students received only routine clinical training in the operating room, including attending the OR, performing the scrub nurse role, and receiving direct feedback from the clinical instructor during the 15-day internship.
|
Standard clinical training in the operating room including attendance, performing the scrub nurse role, and receiving direct feedback from the clinical instructor during the 15-day internship.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Scrub Nurse Performance Score
Časové okno: Baseline (day 1) and day 15 (end of 15-day internship)
|
Performance assessed using a validated 43-item researcher-made checklist covering preoperative (13 items), intraoperative (24 items), and postoperative (6 items) phases.
Each item is scored on a three-point scale: 0 = does not perform, 1 = performs incompletely, and 2 = performs correctly.
The total score ranges from 0 to 86, with higher scores indicating better performance.
The checklist was validated for content validity and reliability through expert review and pilot testing.
|
Baseline (day 1) and day 15 (end of 15-day internship)
|
|
Within-Group Pre-Post Score Changes
Časové okno: Baseline to day 15
|
Comparison of Scrub Nurse Performance Scores (measured using a validated 43-item checklist, total score range: 0-86, with higher scores indicating better performance) before and after the 15-day internship within each group using paired t-tests.
|
Baseline to day 15
|
|
Between-Group Post-Test Score Comparison
Časové okno: Day 15
|
Comparison of Scrub Nurse Performance Scores (measured using a validated 43-item checklist, total score range: 0-86, with higher scores indicating better performance) between the intervention and control groups after the 15-day internship using independent t-tests.
|
Day 15
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Hamed parnikh, Arak University of Medical Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Arak-DHS-2024
- IR.ARAKMU.REC.1403.219 (Jiný identifikátor: Ethics Committee of Arak University of Medical Sciences)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .