Effect of Work Load and Sleep Deprivation on Medical Staff's Driving Skills
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|ClinicalTrials.gov Identifier: NCT00849706|
Recruitment Status : Unknown
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : February 24, 2009
Last Update Posted : February 24, 2009
|Condition or disease||Intervention/treatment|
|Sleep Deprivation||Other: Study participants will work their regular shifts, and tested after night shifts.No shifts will be added because of the study.|
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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.
- 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.
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Effect of Work Load and Sleep Deprivation on Medical Staff's Driving Skills|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||March 2010|
Medical staff personal, doctors and nurses, working night shifts.
Other: Study participants will work their regular shifts, and tested after night shifts.No shifts will be added because of the study.
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.
- Change in driving simulator test results after night shifts compared with control. [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849706
|Contact: Tomer Adar, MDfirstname.lastname@example.org|
|Hadassah Medical Organization, Jerusalem, Israel||Not yet recruiting|
|Jerusalem, Ein-Kerem, Israel, POB 12000|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 email@example.com|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 firstname.lastname@example.org|
|Principal Investigator: Tomer Adar, MD|
|Sub-Investigator: Gadi Lalazar, MD|
|Sub-Investigator: Mizrahi Mair, MD|
|Sub-Investigator: Yuval Hor Horowitz, MD|
|Sub-Investigator: Efrat Orenbuch-Harroch, MD|