Shift-work DisorderNCT04813536
Shift Work Health Effects
An observational study of Shift-work Disorder, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Shift-work Disorder
- What is being tested?
- the Standard Shiftwork Index questionnaire, complete blood picture and lipid profile
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Adult
Study population: Active working nurses working in Assiut University Hospitals with minimum exposure to work shift for 1 year
Who may be able to join
- Active working nurses working in Assiut University Hospitals with minimum exposure to work shift for 1 year .
- Had free pre-employment records
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Samar Mohsen, demonstrator contact
About this study
Official title: Effect of Work Shift on the Nurses' Health in the Main Assiut University Hospital
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.
Read the detailed 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.
- Conditions
- Shift-work Disorder
- Being tested
- the Standard Shiftwork Index questionnaire, complete blood picture, lipid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Standard Shiftwork Index questionnaireOther
- 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 pictureOther
5ml blood to estimate changes of total leucocytic count, Hemoglobin, eosinophilic, monocyte
lipid profileOther
5ml blood to estimate changes of plasma triglycerides, total cholesterol, low-density lipoprotein cholesterol (LDL-C), and HDL-C
| Study group | Role | What they receive |
|---|---|---|
| nurses in Assiut university hospitals | currently working nurses exposed to shift work Receives: Other: the Standard Shiftwork Index questionnaire; Other: complete blood picture; Other: lipid profile | |
| control group | currently working nurses not exposed to shift work Receives: Other: the Standard Shiftwork Index questionnaire; Other: complete blood picture; Other: lipid profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete blood picture
total leucocytic count
Measured: once baseline at time of the data collection of study
complete blood picture
Hemoglobin
Measured: once baseline at time of the data collection of study
complete blood picture
eosinophilic count
Measured: once baseline at time of the data collection of study
complete blood picture
monocyte count
Measured: once baseline at time of the data collection of study
lipid profile
plasma triglycerides
Measured: once baseline at time of data collection
lipid profile
total cholesterol
Measured: once baseline at time of data collection
lipid profile
low-density lipoprotein cholesterol (LDL-C)
Measured: once baseline at time of data collection
lipid profile
HDL-C
Measured: once baseline at time of data collection
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
Measured: once baseline at time of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Shift-work DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Roshdy Elkhayat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813536
- Sponsor's protocol ID
- shift work
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. doi: 10.26719/2017.23.4.295.
PubMed 28634980Merchaoui 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.
PubMed 28451036Ferri 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. doi: 10.2147/RMHP.S115326. eCollection 2016.
PubMed 27695372Dehring 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.
PubMed 30053871
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Work Shift on the Nurses' Health in the Main Assiut University Hospital
- ClinicalTrials.gov ID
- NCT04813536
- Acronym / sponsor ID
- shift work
- Conditions
- Shift-work Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nurses in Assiut university hospitals | – | Other: the Standard Shiftwork Index questionnaire, Other: complete blood picture, Other: lipid profilecurrently working nurses exposed to shift work |
| control group | – | Other: the Standard Shiftwork Index questionnaire, Other: complete blood picture, Other: lipid profilecurrently working nurses not exposed to shift work |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Active working nurses working in Assiut University Hospitals with minimum exposure to work shift for 1 year
Key inclusion criteria (2 listed)
- Active working nurses working in Assiut University Hospitals with minimum exposure to work shift for 1 year .
- Had free pre-employment records
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Standard Shiftwork Index questionnaire1. 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 2. Sleep and fatigue: Measures the effect of shiftwork on perceived sleep quality and quantity and fatigue | Other | control group, nurses in Assiut university hospitals |
| complete blood picture5ml blood to estimate changes of total leucocytic count, Hemoglobin, eosinophilic, monocyte | Other | control group, nurses in Assiut university hospitals |
| lipid profile5ml blood to estimate changes of plasma triglycerides, total cholesterol, low-density lipoprotein cholesterol (LDL-C), and HDL-C | Other | control group, nurses in Assiut university hospitals |
Primary outcome
complete blood picture
Time frame: once baseline at time of the data collection of study
total leucocytic count
complete blood picture
Time frame: once baseline at time of the data collection of study
Hemoglobin
complete blood picture
Time frame: once baseline at time of the data collection of study
eosinophilic count
complete blood picture
Time frame: once baseline at time of the data collection of study
monocyte count
lipid profile
Time frame: once baseline at time of data collection
plasma triglycerides
lipid profile
Time frame: once baseline at time of data collection
total cholesterol
lipid profile
Time frame: once baseline at time of data collection
low-density lipoprotein cholesterol (LDL-C)
lipid profile
Time frame: once baseline at time of data collection
HDL-C
Sleep Questionnaire
Time frame: once baseline at time of data collection
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 28634980Gadallah 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. doi: 10.26719/2017.23.4.295.
- Background: PubMed 28451036Merchaoui 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.
- Background: PubMed 27695372Ferri 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. doi: 10.2147/RMHP.S115326. eCollection 2016.
- Background: PubMed 30053871Dehring 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar Mohsen, demonstrator contact
Questions about this trial
What is this clinical trial studying?
An observational study of Shift-work Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam R Elkhayat, lecturer (+20 00201003708261, mariam.elkhayat@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete blood picture (time frame: once baseline at time of the data collection of study). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813536, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.