Effects of Shift Work on Nurse Staff Health (Turnisti)

January 15, 2020 updated by: Istituto Ortopedico Galeazzi

Effects of Shift Work on Health: Assessment of Sleep Quality, Motor Control and Cardiovascular Risk.

Shift work deeply impacts on temporal organization leading to a circadian desynchronization, which translates into a worsening of the sleep quality and work ability during waking hours. Furthermore, also the fine motor control skills and the subjective mood profile could undergo modifications in relation to the acquired sleep debt. The misalignment between working time and physiological/behavioral functions could have negative influences on the levels of spontaneous daily activity, with possible alteration of the activity-rest rhythm of the worker, especially in clinics.

In relation to the participants' chronotype, the aim of this project will be to evaluate the effect of irregular working hours (shift work) on (i) the sleep quality, (ii) the circadian rhythm of activity levels and, (iii) the motor control. These assessments will help to identify the shift type with less impact on the health status in a nurse cohort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Shift work can exert numerous effects on the temporal and behavioral organization of the individuals. Working hours of shift workers, which are outside the normal daily social program, lead to a circadian desynchronization due to a temporary misalignment between working time and physiological and behavioral functions, similarly to what is observed in the jet lag syndrome. This may lead to deterioration in the sleep quality, reduction in the working ability during waking hours, with sleepiness and a reduction in the vigilance state.

Over the years, the impact of shift work has involved many areas and its effects have been investigated at the cardiovascular (coronary artery disease, hypertension), metabolic (diabetes and obesity) and immunological level. Several investigations provided evidence of the shift work-induced negative results on health, including carcinogenic effects. Consequently, the scientific community paid to these problems great attention.

In analyzing the health effects of shift work, the chronotype of the workers, or their circadian typology, is very important. In fact, the circadian rhythms represent a dimension of the human personality that should not be underestimated. The human being has a temporal organization, determined by the interaction of endogenous and environmental factors, and organizes most of the biological and behavioral activities according to a twenty-four hour period and in sync with the light-dark cycle. It is not worthy to mention that the biological rhythms in humans present interindividual differences that determine precisely the chronotype, which is the tendency to express preferences toward morning or evening activities. Within the population, it is possible to recognize subjects that can be traced to three circadian types: (i) morning-types subjects (M-Types) that tend to be more active and efficient in the first part of the day, (ii) evening-types subjects (E-Types) who find it difficult to get up in the morning and require more time to reach the optimal level of physical and mental efficiency, and (iii) intermediate subjects (Neither-Types, N-Types) that present intermediate characteristics between the previous two.

Previous studies suggested that the eveningness could determine an easier adaptability to the changes determined by shift work. However, the role of the chronotype on this aspect is yet to be related to the type of shift: on one side, the E-Types tend to have more sleep disorders induced by a diurnal working shift. On the other side, the M-Types tend to adapt worst to a night working shift. In any case, shift work determines a growing sleep debt that can have a not negligible impact on the wellbeing and health of the individual.

The association between shift work and cardiovascular risk is very interesting. Sleep at night, in fact, can have important effects on blood pressure. Some studies have shown that a good sleep quality may have potential effects in the prevention of hypertension. Arterial pressure decreases by an average of 10-20% during nighttime hours, so sleep debt could lead to higher average blood pressure over the course of twenty-four hours. In addition, by modifying the circadian rhythms, the shift may lead to an alteration of the autonomic nervous system regulation with hypertensive consequences.

This project will focus on a particular category of shift workers, i.e., the nurse staff working in a hospital. Nurse staff has three different shift schedules: (i) shift changes every day (the first day from 7.00 to 14.00, the second day from 14.00 to 21.00, the third day from 21.00 to 7.00, the fourth day night off and, the fifth day rest), with a "shift cycle" duration of 5 days; (ii) shift changes every two days (first and second day from 7.00 to 14.00, third and fourth day from 14.00 to 21.00, fifth day rest, sixth and seventh day from 21.00 to 7.00, eighth day night off and ninth and tenth day rest), with a shift cycle of 10 days; and (iii) only diurnal shifts (first day from 7.00 to 14.00 and the second day from 14.00 to 21.00), with 2 days of rest every 5 work days.

To this purpose, the aim of this project will be to identify the type of shift work schedule with less impact on the state of health of the hospital staff by evaluating the effect of different shift work schedules on the quality of sleep, on the circadian rhythm of activity levels and on motor control, in relation to the participants' chronotype.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20161
        • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Work shift continuity in a specific group of at least one year.

Exclusion Criteria:

  • Presence of cardiovascular, endocrine or metabolic diseases;
  • Presence of neurological or musculoskeletal impairments at finger flexors muscles level;
  • Pharmacological therapies in place that can affect the heart rate and the sleep quality;
  • Self-declaration of pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
Shifts over 24-hours, shift cycle of 5 days (morning, afternoon, night, night off, rest).
Other: Shifts working hours with different schedules

Workers in Group 1, 2, and 3 will undergo three different shift work modalities presenting different schedules.

Importantly, as an inclusion criteria, workers have to be involved in the same shift modality for at least one year at the time at the beginning of the study.
EXPERIMENTAL: Group 2
Shifts over 24-hours, shift cycle of 10 days (morning, morning, afternoon, afternoon, rest, night, night, night off, rest, rest).
Other: Shifts working hours with different schedules

Workers in Group 1, 2, and 3 will undergo three different shift work modalities presenting different schedules.

Importantly, as an inclusion criteria, workers have to be involved in the same shift modality for at least one year at the time at the beginning of the study.
ACTIVE_COMPARATOR: Group 3
Only diurnal shifts, shift cycle of 5 days (morning, afternoon, morning, afternoon, morning, rest, rest).
Other: Shifts working hours with different schedules

Workers in Group 1, 2, and 3 will undergo three different shift work modalities presenting different schedules.

Importantly, as an inclusion criteria, workers have to be involved in the same shift modality for at least one year at the time at the beginning of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Efficiency (SE)
Time Frame: 8 days
Percentage of time spent in bed with actual sleep
8 days
Sleep Latency (SL)
Time Frame: 8 days
period of time between bed and sleep
8 days
Movement and Fragmentation Index (MFI)
Time Frame: 8 days
Percentage of time spent moving indicative of the fragmentation of sleep
8 days
Immobile Time (IT)
Time Frame: 8 days
total time spent without movement, between sleep from start to sleep
8 days
Assumed Sleep (AS)
Time Frame: 8 days
Difference between beginning and end of sleep
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of Mood States (POMS)
Time Frame: Baseline and 8 days
Questionnaire for the determination of the mood profile
Baseline and 8 days
Finger flexor muscles maximum voluntary contraction (MVC)
Time Frame: Baseline and 8 days
Evaluation of the maximum isometric force output of the finger flexors muscles
Baseline and 8 days
Force coefficient of variation (CV)
Time Frame: Baseline and 8 days
Ratio between the standard deviation of the force signal during the plateau phase and the mean of the force signal (index of muscle contraction stability)
Baseline and 8 days
Distance of the force signal (DF)
Time Frame: Baseline and 8 days
distance of the force signal with respect to the target (index of force accuracy )
Baseline and 8 days
Surface electromyography (sEMG) root mean square (RMS) of finger flexor muscles
Time Frame: Baseline and 8 days
Index of muscle activation reflecting the number of recruited motor units during contraction
Baseline and 8 days
Surface electromyography (sEMG) mean frequency (MF) of finger flexor muscles
Time Frame: Baseline and 8 days
Index reflecting the mean rate of activation of the recruited motor units during contraction
Baseline and 8 days
Hearth Rate Variability (HRV)
Time Frame: Baseline and 8 days
Quantification of the sympatho-vagal balance
Baseline and 8 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ)
Time Frame: Baseline
Questionnaire for chronotype determination.The MEQ has 19 items, and the answer options include using a visual analog scale and choosing between four or five options. Participants are classified as Morning-types (scores between 59 and 86), Neither-types (scores between 42 and 58), and Evening-types (scores between 16 and 41).
Baseline
International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline
Questionnaire for the assessment of the level of physical activity. The number of days and minutes in a week dedicated at walking or in moderate or heavy physical activities are converted in metabolic equivalent units (METs). The sum of the METs identifies the level of physical activity: METs < 700 = inactive; METs from 700 to 2519 = adequately active; METs > 2519 highly active.
Baseline
QRISK2-2017 questionnaire
Time Frame: Baseline
Questionnaire for cardiovascular risk assessment. The questionnaire provides a score (in percentage) of the risk of having a heart attack or stroke within the next 10 years. Score ranges from 0.1% (lowest risk) and 100% (maximum risk).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Investigators

  • Principal Investigator: Fabio Esposito, MD, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 23, 2018

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

January 15, 2020

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (ACTUAL)

March 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Turnisti

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous individual participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Data will be available within 6 months from the end of the study.

IPD Sharing Access Criteria

Data access request will be reviewed by the principal investigator and co-investigators.

Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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