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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04813536
Other study ID # shift work
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2021
Est. completion date December 2022

Study information

Verified date March 2021
Source Assiut University
Contact Mariam R Elkhayat, lecturer
Phone +20 00201003708261
Email mariam.elkhayat@aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To identify the health effects of shift work on nurses in Assuit university hospitals . To estimate effect of shift work on co-morbidities among nurses . To determine the shift work associated risk factors predisposing nurses to poor health outcomes and injuries.


Description:

The word 'shiftwork' is commonly used to describe irregular, odd, untraditional working hours, or working hours that are away from day work period. Shiftwork dates back to the late 1800s, as applied to guardians of old kingdoms and in the military services. After the innovation of the light, shift work expanded for nonstop production as in steel factories, iron foundries, and material plants. Approximately one-fourth of the workforce in hospitals works unusual hours (away from the traditional diurnal work period) . Shiftwork has a number of advantages and disadvantages to employers, employees, and their families. The advantages for employers include optimal use of energy, facilities, and other resources through extended capital operating time. The advantages for employees include increased income, more free time for daily activities, and saving time by avoiding traffic rush hours. Shiftwork is associated with both short-term and long-term disadvantages on physical and psychophysiological health. Short-term effects include fatigue and difficulties with sleep. Difficulties with sleep are found to be the most common complaint among shift workers. Sleep disturbances were the main reasons that led shift workers to leave night shiftwork owing to disturbed health habits compared with day workers .Gastrointestinal disorders were reported 2-5 times more commonly among shift workers than daytime workers. These disorders range from minor complaints (e.g., constipation, heart burn, distension, and disturbed appetite) to serious gastrointestinal disorders, which may develop into chronic diseases such as chronic gastritis or peptic ulcers. Shiftwork has been also linked to type 2 diabetes and obesity as sleep deprivation activates the immune system and influences glucose metabolism . An association between shiftwork and cardiovascular diseases (CVDs) has been reported. There is a higher risk for CVD such as hypertension, subclinical atherosclerosis, and ischemic heart disease compared with daytime workers . Different types of cancer have been reported in shift workers including cancers of the breast, colon, and endometrium. Shiftwork system causes circadian rhythm disruption, which is probably carcinogenic to humans. Also, shiftwork causes disruption in both social and domestic lifestyle, which is a major consequence of shiftwork, especially with maternal employment that may have some adverse influences on their young children's cognitive and behavioral outcomes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 108
Est. completion date December 2022
Est. primary completion date June 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Active working nurses working in Assiut University Hospitals with minimum exposure to work shift for 1 year . - Had free pre-employment records Exclusion Criteria: - Nurses don't record shift work exposure. - Nurses with less than 1 year exposure to shift work, or don't recorded shift work exposure. - Nurses known to had autoimmune disorder or endocrinal disorder before joining job.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
the Standard Shiftwork Index questionnaire
Biographical information: This includes personal data (e.g., age, sex, marital status, and domestic situations), shift details (e.g., shift start and end times), organization of shiftwork, and general job satisfaction Sleep and fatigue: Measures the effect of shiftwork on perceived sleep quality and quantity and fatigue
complete blood picture
5ml blood to estimate changes of total leucocytic count, Hemoglobin, eosinophilic, monocyte
lipid profile
5ml blood to estimate changes of plasma triglycerides, total cholesterol, low-density lipoprotein cholesterol (LDL-C), and HDL-C

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Dehring T, von Treuer K, Redley B. The impact of shift work and organisational climate on nurse health: a cross-sectional study. BMC Health Serv Res. 2018 Jul 27;18(1):586. doi: 10.1186/s12913-018-3402-5. — View Citation

Ferri P, Guadi M, Marcheselli L, Balduzzi S, Magnani D, Di Lorenzo R. The impact of shift work on the psychological and physical health of nurses in a general hospital: a comparison between rotating night shifts and day shifts. Risk Manag Healthc Policy. 2016 Sep 14;9:203-211. eCollection 2016. — View Citation

Gadallah M, Hakim SA, Mohsen A, Eldin WS. Association of rotating night shift with lipid profile among nurses in an Egyptian tertiary university hospital. East Mediterr Health J. 2017 Jun 14;23(4):295-302. — View Citation

Merchaoui I, Bouzgarrou L, Mnasri A, Mghanem M, Akrout M, Malchaire J, Chaari N. Influence of shift work on the physical work capacity of Tunisian nurses: a cross-sectional study in two university hospitals. Pan Afr Med J. 2017 Feb 2;26:59. doi: 10.11604/pamj.2017.26.59.11279. eCollection 2017. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary complete blood picture total leucocytic count once baseline at time of the data collection of study
Primary complete blood picture Hemoglobin once baseline at time of the data collection of study
Primary complete blood picture eosinophilic count once baseline at time of the data collection of study
Primary complete blood picture monocyte count once baseline at time of the data collection of study
Primary lipid profile plasma triglycerides once baseline at time of data collection
Primary lipid profile total cholesterol once baseline at time of data collection
Primary lipid profile low-density lipoprotein cholesterol (LDL-C) once baseline at time of data collection
Primary lipid profile HDL-C once baseline at time of data collection
Primary Sleep Questionnaire part of standard shift work index,consists of 11 items and aims to identify sleep habits, as well as the extent to which sleep is depending on which shift has been or is about to be worked. A higher score is associated being associated with higher sleep disturbance once baseline at time of data collection
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