search
Back to results

Effects of Shift Work on Nurse Staff Health (Turnisti)

Primary Purpose

Shift Work Type Circadian Rhythm Sleep Disorder, Chronobiology Disorders, Mood Swing

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Shifts working hours with different schedules
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shift Work Type Circadian Rhythm Sleep Disorder focused on measuring Chronotype, Shift work, Health status

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • IRCCS Istituto Ortopedico Galeazzi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Shifts over 24-hours, shift cycle of 5 days (morning, afternoon, night, night off, rest).

Shifts over 24-hours, shift cycle of 10 days (morning, morning, afternoon, afternoon, rest, night, night, night off, rest, rest).

Only diurnal shifts, shift cycle of 5 days (morning, afternoon, morning, afternoon, morning, rest, rest).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2018
Last Updated
January 15, 2020
Sponsor
Istituto Ortopedico Galeazzi
search

1. Study Identification

Unique Protocol Identification Number
NCT03453398
Brief Title
Effects of Shift Work on Nurse Staff Health
Acronym
Turnisti
Official Title
Effects of Shift Work on Health: Assessment of Sleep Quality, Motor Control and Cardiovascular Risk.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift Work Type Circadian Rhythm Sleep Disorder, Chronobiology Disorders, Mood Swing, Physical Activity, Cardiovascular Diseases
Keywords
Chronotype, Shift work, Health status

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are divided in three different groups on the bases of their actual shift work modalities. Thus no allocation process is possible within this project.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Shifts over 24-hours, shift cycle of 5 days (morning, afternoon, night, night off, rest).
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Shifts over 24-hours, shift cycle of 10 days (morning, morning, afternoon, afternoon, rest, night, night, night off, rest, rest).
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Only diurnal shifts, shift cycle of 5 days (morning, afternoon, morning, afternoon, morning, rest, rest).
Intervention Type
Other
Intervention Name(s)
Shifts working hours with different schedules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep Efficiency (SE)
Description
Percentage of time spent in bed with actual sleep
Time Frame
8 days
Title
Sleep Latency (SL)
Description
period of time between bed and sleep
Time Frame
8 days
Title
Movement and Fragmentation Index (MFI)
Description
Percentage of time spent moving indicative of the fragmentation of sleep
Time Frame
8 days
Title
Immobile Time (IT)
Description
total time spent without movement, between sleep from start to sleep
Time Frame
8 days
Title
Assumed Sleep (AS)
Description
Difference between beginning and end of sleep
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Profile of Mood States (POMS)
Description
Questionnaire for the determination of the mood profile
Time Frame
Baseline and 8 days
Title
Finger flexor muscles maximum voluntary contraction (MVC)
Description
Evaluation of the maximum isometric force output of the finger flexors muscles
Time Frame
Baseline and 8 days
Title
Force coefficient of variation (CV)
Description
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)
Time Frame
Baseline and 8 days
Title
Distance of the force signal (DF)
Description
distance of the force signal with respect to the target (index of force accuracy )
Time Frame
Baseline and 8 days
Title
Surface electromyography (sEMG) root mean square (RMS) of finger flexor muscles
Description
Index of muscle activation reflecting the number of recruited motor units during contraction
Time Frame
Baseline and 8 days
Title
Surface electromyography (sEMG) mean frequency (MF) of finger flexor muscles
Description
Index reflecting the mean rate of activation of the recruited motor units during contraction
Time Frame
Baseline and 8 days
Title
Hearth Rate Variability (HRV)
Description
Quantification of the sympatho-vagal balance
Time Frame
Baseline and 8 days
Other Pre-specified Outcome Measures:
Title
Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ)
Description
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).
Time Frame
Baseline
Title
International Physical Activity Questionnaire (IPAQ)
Description
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.
Time Frame
Baseline
Title
QRISK2-2017 questionnaire
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Esposito, MD
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
State/Province
MI
ZIP/Postal Code
20161
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
23004349
Citation
Adan A, Archer SN, Hidalgo MP, Di Milia L, Natale V, Randler C. Circadian typology: a comprehensive review. Chronobiol Int. 2012 Nov;29(9):1153-75. doi: 10.3109/07420528.2012.719971. Epub 2012 Sep 24.
Results Reference
background
PubMed Identifier
15310506
Citation
Akerstedt T. Shift work and disturbed sleep/wakefulness. Sleep Med Rev. 1998 May;2(2):117-28. doi: 10.1016/s1087-0792(98)90004-1.
Results Reference
background
PubMed Identifier
17481949
Citation
Boivin DB, Tremblay GM, James FO. Working on atypical schedules. Sleep Med. 2007 Sep;8(6):578-89. doi: 10.1016/j.sleep.2007.03.015. Epub 2007 May 3.
Results Reference
background
PubMed Identifier
25216205
Citation
Costa G, Anelli MM, Castellini G, Fustinoni S, Neri L. Stress and sleep in nurses employed in "3 x 8" and "2 x 12" fast rotating shift schedules. Chronobiol Int. 2014 Dec;31(10):1169-78. doi: 10.3109/07420528.2014.957309. Epub 2014 Sep 12.
Results Reference
background
PubMed Identifier
23976988
Citation
Guo Y, Liu Y, Huang X, Rong Y, He M, Wang Y, Yuan J, Wu T, Chen W. The effects of shift work on sleeping quality, hypertension and diabetes in retired workers. PLoS One. 2013 Aug 16;8(8):e71107. doi: 10.1371/journal.pone.0071107. eCollection 2013.
Results Reference
background
PubMed Identifier
352650
Citation
Halberg F, Carandente F, Cornelissen G, Katinas GS. [Glossary of chronobiology (author's transl)]. Chronobiologia. 1977;4 Suppl 1:1-189. No abstract available. Italian.
Results Reference
background
PubMed Identifier
8440205
Citation
Harma M. Individual differences in tolerance to shiftwork: a review. Ergonomics. 1993 Jan-Mar;36(1-3):101-9. doi: 10.1080/00140139308967860.
Results Reference
background
PubMed Identifier
21148212
Citation
Hippisley-Cox J, Coupland C, Robson J, Brindle P. Derivation, validation, and evaluation of a new QRISK model to estimate lifetime risk of cardiovascular disease: cohort study using QResearch database. BMJ. 2010 Dec 9;341:c6624. doi: 10.1136/bmj.c6624.
Results Reference
background
PubMed Identifier
18573856
Citation
Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, Minhas R, Sheikh A, Brindle P. Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2. BMJ. 2008 Jun 28;336(7659):1475-82. doi: 10.1136/bmj.39609.449676.25. Epub 2008 Jun 23.
Results Reference
background
PubMed Identifier
1027738
Citation
Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
Results Reference
background
PubMed Identifier
23606613
Citation
Juda M, Vetter C, Roenneberg T. Chronotype modulates sleep duration, sleep quality, and social jet lag in shift-workers. J Biol Rhythms. 2013 Apr;28(2):141-51. doi: 10.1177/0748730412475042.
Results Reference
background
PubMed Identifier
26035480
Citation
Martin JS, Laberge L, Sasseville A, Berube M, Alain S, Houle J, Hebert M. Day and night shift schedules are associated with lower sleep quality in Evening-types. Chronobiol Int. 2015 Jun;32(5):627-36. doi: 10.3109/07420528.2015.1033425. Epub 2015 Jun 2.
Results Reference
background
Citation
Montaruli A, Galasso L, Caumo A, Cè E, Pesenti C, Roveda E, Esposito F. (2017). The circadian typology: the role of physical activity and melatonin. Sport Sciences for Health 1-8, 2017
Results Reference
background
PubMed Identifier
28426388
Citation
Montaruli A, Galasso L, Carandente F, Vitale JA, Roveda E, Caumo A. If the Morning-Evening Questionnaire (MEQ) is able to predict the actigraphy-based acrophase, how does its reduced, five-item version (rMEQ) perform? Chronobiol Int. 2017;34(4):443-444. doi: 10.1080/07420528.2017.1306708. No abstract available.
Results Reference
background
PubMed Identifier
548245
Citation
Nelson W, Tong YL, Lee JK, Halberg F. Methods for cosinor-rhythmometry. Chronobiologia. 1979 Oct-Dec;6(4):305-23. No abstract available.
Results Reference
background
PubMed Identifier
15211428
Citation
Newey CA, Hood BM. Determinants of shift-work adjustment for nursing staff: the critical experience of partners. J Prof Nurs. 2004 May-Jun;20(3):187-95. doi: 10.1016/j.profnurs.2004.04.007.
Results Reference
background
PubMed Identifier
11583769
Citation
Rajaratnam SM, Arendt J. Health in a 24-h society. Lancet. 2001 Sep 22;358(9286):999-1005. doi: 10.1016/S0140-6736(01)06108-6.
Results Reference
background
PubMed Identifier
27252076
Citation
Roveda E, Vitale JA, Bruno E, Montaruli A, Pasanisi P, Villarini A, Gargano G, Galasso L, Berrino F, Caumo A, Carandente F. Protective Effect of Aerobic Physical Activity on Sleep Behavior in Breast Cancer Survivors. Integr Cancer Ther. 2017 Mar;16(1):21-31. doi: 10.1177/1534735416651719. Epub 2016 Jun 1.
Results Reference
background
PubMed Identifier
28276851
Citation
Roveda E, Vitale J, Montaruli A, Galasso L, Carandente F, Caumo A. Predicting the actigraphy-based acrophase using the Morningness-Eveningness Questionnaire (MEQ) in college students of North Italy. Chronobiol Int. 2017;34(5):551-562. doi: 10.1080/07420528.2016.1276928. Epub 2017 Feb 21.
Results Reference
background
PubMed Identifier
20851006
Citation
Saksvik IB, Bjorvatn B, Hetland H, Sandal GM, Pallesen S. Individual differences in tolerance to shift work--a systematic review. Sleep Med Rev. 2011 Aug;15(4):221-35. doi: 10.1016/j.smrv.2010.07.002. Epub 2010 Sep 20.
Results Reference
background
PubMed Identifier
11604480
Citation
Schernhammer ES, Laden F, Speizer FE, Willett WC, Hunter DJ, Kawachi I, Colditz GA. Rotating night shifts and risk of breast cancer in women participating in the nurses' health study. J Natl Cancer Inst. 2001 Oct 17;93(20):1563-8. doi: 10.1093/jnci/93.20.1563.
Results Reference
background
PubMed Identifier
11213026
Citation
Munakata M, Ichi S, Nunokawa T, Saito Y, Ito N, Fukudo S, Yoshinaga K. Influence of night shift work on psychologic state and cardiovascular and neuroendocrine responses in healthy nurses. Hypertens Res. 2001 Jan;24(1):25-31. doi: 10.1291/hypres.24.25.
Results Reference
background
PubMed Identifier
34444128
Citation
Galasso L, Mule A, Castelli L, Ce E, Condemi V, Banfi G, Roveda E, Montaruli A, Esposito F. Effects of Shift Work in a Sample of Italian Nurses: Analysis of Rest-Activity Circadian Rhythm. Int J Environ Res Public Health. 2021 Aug 8;18(16):8378. doi: 10.3390/ijerph18168378.
Results Reference
derived

Learn more about this trial

Effects of Shift Work on Nurse Staff Health

We'll reach out to this number within 24 hrs