- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Arak, Iran
- Hamed
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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.
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Comparatore attivo: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Scrub Nurse Performance Score
Lasso di tempo: Baseline (day 1) and day 15 (end of 15-day internship)
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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.
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Baseline (day 1) and day 15 (end of 15-day internship)
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Within-Group Pre-Post Score Changes
Lasso di tempo: Baseline to day 15
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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.
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Baseline to day 15
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Between-Group Post-Test Score Comparison
Lasso di tempo: Day 15
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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.
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Day 15
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Hamed parnikh, Arak University of Medical Sciences
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Arak-DHS-2024
- IR.ARAKMU.REC.1403.219 (Altro identificatore: Ethics Committee of Arak University of Medical Sciences)
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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