NCT04813536

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 20, 2021

Last Update Submit

March 20, 2021

Conditions

Outcome Measures

Primary Outcomes (9)

  • complete blood picture

    total leucocytic count

    once baseline at time of the data collection of study

  • complete blood picture

    Hemoglobin

    once baseline at time of the data collection of study

  • complete blood picture

    eosinophilic count

    once baseline at time of the data collection of study

  • complete blood picture

    monocyte count

    once baseline at time of the data collection of study

  • lipid profile

    plasma triglycerides

    once baseline at time of data collection

  • lipid profile

    total cholesterol

    once baseline at time of data collection

  • lipid profile

    low-density lipoprotein cholesterol (LDL-C)

    once baseline at time of data collection

  • lipid profile

    HDL-C

    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

    once baseline at time of data collection

Study Arms (2)

nurses in Assiut university hospitals

currently working nurses exposed to shift work

Other: the Standard Shiftwork Index questionnaireOther: complete blood pictureOther: lipid profile

control group

currently working nurses not exposed to shift work

Other: the Standard Shiftwork Index questionnaireOther: complete blood pictureOther: lipid profile

Interventions

1. 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

control groupnurses in Assiut university hospitals

5ml blood to estimate changes of total leucocytic count, Hemoglobin, eosinophilic, monocyte

control groupnurses in Assiut university hospitals

5ml blood to estimate changes of plasma triglycerides, total cholesterol, low-density lipoprotein cholesterol (LDL-C), and HDL-C

control groupnurses in Assiut university hospitals

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Active working nurses working in Assiut University Hospitals with minimum exposure to work shift for 1 year

You may qualify if:

  • Active working nurses working in Assiut University Hospitals with minimum exposure to work shift for 1 year .
  • Had free pre-employment records

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 28634980BACKGROUND
  • 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.

    PMID: 28451036BACKGROUND
  • 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. doi: 10.2147/RMHP.S115326. eCollection 2016.

    PMID: 27695372BACKGROUND
  • 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.

    PMID: 30053871BACKGROUND

Central Study Contacts

Mariam R Elkhayat, lecturer

CONTACT

Samar Mohsen, demonstrator

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 20, 2021

First Posted

March 24, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

March 24, 2021

Record last verified: 2021-03