Effects of Shift Work on Nurse Staff Health

NCT03453398 | Completed

• 1 other identifier: Turnisti
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Shift Work Type Circadian Rhythm Sleep Disorder; Chronobiology Disorders; Mood Swing; Physical Activity; Cardiovascular Diseases

Keywords

Chronotype; Shift work; Health status

Outcome Measures

Primary Outcomes (5)

• Sleep Efficiency (SE)

  Percentage of time spent in bed with actual sleep

  8 days

• Sleep Latency (SL)

  period of time between bed and sleep

  8 days

• Movement and Fragmentation Index (MFI)

  Percentage of time spent moving indicative of the fragmentation of sleep

  8 days

• Immobile Time (IT)

  total time spent without movement, between sleep from start to sleep

  8 days

• Assumed Sleep (AS)

  Difference between beginning and end of sleep

  8 days

Secondary Outcomes (7)

• Profile of Mood States (POMS)

  Baseline and 8 days

• Finger flexor muscles maximum voluntary contraction (MVC)

  Baseline and 8 days

• Force coefficient of variation (CV)

  Baseline and 8 days

• Distance of the force signal (DF)

  Baseline and 8 days

• Surface electromyography (sEMG) root mean square (RMS) of finger flexor muscles

  Baseline and 8 days

Other Outcomes (3)

• Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ)

  Baseline

• International Physical Activity Questionnaire (IPAQ)

  Baseline

• QRISK2-2017 questionnaire

  Baseline

Study Arms (3)

Group 1

EXPERIMENTAL

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

Other: Shifts working hours with different schedules

Group 2

EXPERIMENTAL

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

Group 3

ACTIVE COMPARATOR

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

Other: Shifts working hours with different schedules

Interventions

Shifts working hours with different schedules OTHER

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.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, MI, 20161, Italy

Location

Related Publications (23)

• 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.

  PMID: 23004349 BACKGROUND

• 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.

  PMID: 15310506 BACKGROUND

• 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.

  PMID: 17481949 BACKGROUND

• 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.

  PMID: 25216205 BACKGROUND

• 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.

  PMID: 23976988 BACKGROUND

• 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.

  PMID: 352650 BACKGROUND

• Harma M. Individual differences in tolerance to shiftwork: a review. Ergonomics. 1993 Jan-Mar;36(1-3):101-9. doi: 10.1080/00140139308967860.

  PMID: 8440205 BACKGROUND

• 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.

  PMID: 21148212 BACKGROUND

• 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.

  PMID: 18573856 BACKGROUND

• Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.

  PMID: 1027738 BACKGROUND

• 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.

  PMID: 23606613 BACKGROUND

• 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.

  PMID: 26035480 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28426388 BACKGROUND

• Nelson W, Tong YL, Lee JK, Halberg F. Methods for cosinor-rhythmometry. Chronobiologia. 1979 Oct-Dec;6(4):305-23. No abstract available.

  PMID: 548245 BACKGROUND

• 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.

  PMID: 15211428 BACKGROUND

• 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.

  PMID: 11583769 BACKGROUND

• 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.

  PMID: 27252076 BACKGROUND

• 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.

  PMID: 28276851 BACKGROUND

• 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.

  PMID: 20851006 BACKGROUND

• 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.

  PMID: 11604480 BACKGROUND

• 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.

  PMID: 11213026 BACKGROUND

• 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.

  PMID: 34444128 DERIVED

MeSH Terms

Conditions

Chronobiology Disorders; Motor Activity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Behavior

Study Officials

• Fabio Esposito, MD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: March 5, 2018
• Study Start: January 23, 2018
• Primary Completion: December 30, 2019
• Study Completion: January 15, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months from the end of the study.
• 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.

Locations

IT (1)