- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00849706
Effect of Work Load and Sleep Deprivation on Medical Staff's Driving Skills
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Medical staff in Israel has long and unorthodox working hours. During residency, doctors stay overnight for shifts after working the normal working hours for a total of 24h, without regular set breaks or certainty of even one hour of sleep. Nurses, has three 8 hours shifts, changing at 7am, 3pm and 11pm, meaning the night shift staff works between 11pm and 7am the following morning. These conditions, especially when in a routine when one shifts follow another, may contribute to an accumulated workload, associated with sleep deprivation. Such conditions may have considerable impact on cognitive functions such as response time and concentration, which are fundamental for medical personal's function.
The driving simulator is based on software (STIS Drive Simulation software, System Technology INC, Hawthorne CA) and a hardware consisting of a computer, screen, and two consoles, one includes a stirring wheel and press buttons, the second includes acceleration and break paddles. Each test drive has several stages, in which the following are measured - the ability to maintain constant speed, the ability to maintain driving lain, to follow another vehicle and to break abruptly. Additionally, during the test drive, several arrows appear on the screen, and the subject is requested to push curtain buttons as they appear according to their direction. This simulator has been used in several prior reports for driving skills evaluation.
In this study, medical staff will be asked to be tested with the driving simulator after night shift, allowing assessment of cognitive functions and response time.
Study design:
- The study will include doctors and nurses from the internal medicine, surgical, orthopedic and pediatric wards which work night shifts.
- The study will include both genders, ages 25-50.
- The study is planned to include 100 volunteers.
Trial entry and enrollment
- The medical staff at the participating departments will be approached orally (staff meetings etc') and signs will be posted at staff rooms.
Willing volunteers will be enrolled according to order of consent.
**Visits 1 and 2
- Visit 1 will include a training session in which the volunteer is introduced to the driving simulator's different functions and will perform a test ride to get experience. At this session, the subject will be asked to fill a form stating his age, residency and main occupation (e.g. extent of familiarity with laparoscopic/ endoscopic procedures).
Visit 2 will include a test ride performed during morning (07:00- 14:00pm) and after a regular night sleep and not after a night shift. Data collected during this session will be considered as baseline values. The following three test visits will be compared to these values.
** Visits 3-5
These visits will be performed after night shifts. Subjects will be tested at the morning (7-10am) following a night shift. Apart form a test drive each subject will be asked to state work and sleep hour during the previous day.
** Visit 6
Subjects which have completed 3 test drives will undergo a repeat baseline assessment (similar to visit 2) to which the following visits will be compared in order to minimize the learning curve component.
** Visits 7-9
- Similar to visits 3-5.
Statistical considerations
- Subjects will be grouped according to sleep hours prior to test drives, and driving simulator results will be compared.
- Furthermore, additional analysis will be performed for individual subjects comparing achievements with sleep hours.
Informed consent
- Each subject will be enrolled and enter the study only after giving an informed consent.
Adherence to study eligibility
- The study will be conducted in accordance with good clinical practice (GCP) guidelines, and the study protocol.
Safeguarding of documents
- The privacy of the subjects and all confidentiality issues will be handled in accordance with applicable law and guidelines of the institution and the Helsinki Committee, the Israeli ministry of health, or the other appropriate regulatory authorities.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Ein-Kerem
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Jerusalem, Ein-Kerem, Israele, POB 12000
- Hadassah Medical Organization, Jerusalem, Israel
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Given informed consent
- Medical staff (doctor / nurse) working night shifts.
- Having a driver's license.
Exclusion Criteria:
- Pregnancy.
- Any systemic / neurological condition which may affect results.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Study group
Medical staff personal, doctors and nurses, working night shifts.
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Night shifts in our medical center are working 8 hours from 23:00 to 7:00 the following day for nurses, and working overnight (24h) for doctors.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change in driving simulator test results after night shifts compared with control.
Lasso di tempo: 2 months
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2 months
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Bajaj JS, Hafeezullah M, Hoffmann RG, Varma RR, Franco J, Binion DG, Hammeke TA, Saeian K. Navigation skill impairment: Another dimension of the driving difficulties in minimal hepatic encephalopathy. Hepatology. 2008 Feb;47(2):596-604. doi: 10.1002/hep.22032.
- Horne J, Reyner L. Vehicle accidents related to sleep: a review. Occup Environ Med. 1999 May;56(5):289-94. doi: 10.1136/oem.56.5.289.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
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
- 481131-HMO-CTIL
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 .
Prove cliniche su Privazione del sonno
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Haseki Training and Research HospitalNon ancora reclutamentoRichards-Campbell Sleep questions (RCSQ)