Characterizing Fatigue Experienced by Registered Nurses

Background:

Nursing is a high-stress job. It can be physically and mentally taxing. Nurses can have health problems due to long work hours, stressful work environments, and shift work. Fatigue is common among registered nurses (RNs). It has been linked with job burnout, missing work, injuries at work, and reduced job performance. Fatigue in RNs has been studied, but researchers want to learn more about it.

Objectives:

To learn more about how fatigue affects registered nurses.

Eligibility:

RNs at least 18 years old who work at NIH

Design:

Part 1: All RNs at the NIH will be invited to participate in an anonymous online survey. They will answer questions about their jobs and fatigue.

Part 2: Fatigue levels in a small group of RNs will be evaluated more closely. They will be screened with questions by phone or in person. They will be asked about their work schedule, ability to speak and read English, and general health.

Participants in Part 2 of the study will have 3 study visits.

-Visit 1 will be at least 48 hours after the last time the participant worked. Participants will fast before the visit. They will have a medical history, physical exam, and blood tests. They will receive a food diary and a sleep watch and diary. They will wear the watch and complete the diaries for 1 week.

Participants will answer questions on an iPad 2 times a day for 4 days. The first day will be when they complete visit 1. They then will do this for 3 workdays in a row. This will be right before and after work on those days. Questions will test their thinking and ask about their feelings.

• Visit 2 will be right after finishing 3 work days in a row. Participants will have blood pressure and blood samples taken.
• Visit 3 will be 1 week after finishing the diaries. Participants will return the sleep watch, iPad, and diaries A dietician may ask them questions about the food diary.

Study Overview

• Status: Terminated
• Conditions: Fatigue

Detailed Description

Objective: The U.S. health care system requires critical nursing services around the clock, resulting in many nurses working overnight hours and having irregular shifts. One symptom commonly associated with the nursing workplace is fatigue, affecting up to 80% of Registered Nurses (RNs). Fatigue is problematic for RNs because it is associated with burnout, absenteeism, job-related injury and reduced job performance. Factors

known to contribute to fatigue are physiological (e.g. sleep disturbances, physical health and nutritional deficiencies), psychological (e.g. depression, anxiety, coping style), and situational (e.g. shiftwork and high work demands). Fatigue in turn negatively affects cognitive performance including memory, attention, and reaction time, as well as mood and quality of life. The pathophysiological mechanisms underlying fatigue are complex and not well understood. Hypothesized pathways include inflammation and autonomic dysregulation. The specific physiological, psychological and situational factors contributing to fatigue in RNs are unclear. Most studies in nurses look at fatigue in general, with few examining specific subtypes such as mental, physical, and emotional fatigue. Very few studies have examined fatigue in RNs longitudinally, nor have they explored the underlying pathophysiology. Little is known about the downstream effects of fatigue on nurses cognitive performance or on their ability to enjoy and participate in life outside of work. Thus, the objective of this study is to characterize fatigue experienced by RNs and to examine the physiologic, psychologic, and situational factors that contribute to fatigue and its subtypes.

AIMS: The primary AIM is to characterize the levels and types of fatigue experienced by RNs, and to examine the physiologic, psychologic and situational factors contributing to fatigue and its subtypes in RNs. The secondary AIM is to examine the relationship between fatigue with cognitive performance, mood, life satisfaction, and the ability to participate in social roles/activities in RNs and to assess changes in cognitive performance and mood over the course of three working days. The exploratory AIM is to explore molecular and clinical biomarkers associated with fatigue in a subset of RNs.

Study population: This study will occur in two parts. Phase I will recruit from a pool of approximately 1,275 RNs at the NIH Clinical Center, and we anticipate that 400 RNs will participate. Phase II will enroll up to 60 RNs, in order to obtain 40 RNs who complete all study timepoints.

Design: This study will utilize an adaptive design whereby a preliminary, anonymous cross-sectional surveyinvolving a large cohort of RNs will address the primary and secondary AIMs (Phase I). Phase II will utilize a prospective, repeated measures design to collect biomarkers of fatigue and health, along with more detailed psychologic, situational, and performance outcomes in a small subset of RNs (n = 40) at multiple time points including baseline (48+ hours after last working) and at the start and conclusion of three consecutive workdays. Phase II will address the primary and secondary AIMS in greater depth and over time, while addressing the exploratory AIMs of the study.

Outcome measures: The primary outcome is fatigue, using the Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) and Occupational Fatigue Exhaustion Recovery (OFER) scale used to: (1) determine the levels and types (general, physical, emotional, mental, acute and chronic) of fatigue experienced by RNs (Phase I), (2) examine whether fatigue and its subtypes change over time (Phase II); and (3) determine which physiologic (sleep disturbance, physical health, nutritional status), psychologic (depression, anxiety, self-efficacy, coping style), and situational (job type, work hours, work demands, professional quality of life, outside demands) factors contribute to fatigue in RNs. Secondary outcomes include downstream performance outcomes believed to be related to fatigue including NIH toolbox measures of cognitive performance, Profile of Mood States (POMS), and PROMIS measures of life satisfaction and the ability to perform social roles/activities. Exploratory factors that potentially influence fatigue (MFSI-SF) will be examined in Phase II including markers of autonomic function (orthostatic blood pressure (BP) and inflammation (hs-CRP, TNF-alpha, IL-6, IL1-beta, and GlycA).

• Study Type: Observational
• Enrollment (Actual): 313

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

registered nurses working in the National Institutes of Health Clinical Center

Description

• INCLUSION CRITERIA:

Phase I

• CCND credentialed RN
• Age > 18 years old
• Able to read and speak English
• Agrees to participate in the study
• Ability to complete online surveys

Phase II

• CCND credentialed RN employed full time
• Age > 18 years old
• Able to read and speak English
• Agrees to participate in the study

EXCLUSION CRITERIA:

Phase I

• Age < 18 years old
• Inability to comprehend investigational nature of study
• Unable to read and speak English
• Unable to complete online surveys

Phase II

• Age < 18 years old
• Inability to comprehend investigational nature of study
• Known phobias or adverse reactions to blood draws
• Inability to provide informed consent
• Unable to read and speak English
• Individuals with a disease or condition that causes fatigue (e.g. heart failure, multiple sclerosis, rheumatoid arthritis)
• Individuals routinely taking prescription medicines that cause fatigue (e.g. beta blockers, narcotics)
• Individuals taking prescription oral anti-inflammatory medications
• Pregnant or lactating women
• Member of the research team

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Volunteers; CC Registered Nurses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue - as measured by the Multidimensional Fatigue Symptom Inventory (MFSI) and the Occupational Fatigue Exhaustion Recovery Scale (OFER)	Total and subscale score for the MFSI and OFER. These measures will be used to describe levels of fatigue in RNs, and to identify factors that contribute to fatigue in RNs	In Phase I = cross sectional only; Phase II: Baseline, Workday 1(beginning and end of shift) Workday 2 (beginning and end of shift), Workday 3 (beginning and end of shift)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Exploratory outcome) Clinical factors/Biomarkers associated with fatigue	Exploratory biomarkers potentially related to fatigue that will be examined include orthostatic blood pressure (measure of autonomic function) and inflammatory biomarkers (hs-CRP, TNF-?, IL-6, IL1-(SqrRoot) , and GlycA)	Phase II: Baseline and Workday three (end of shift)
"Performance" outcomes associated with fatigue: cognitive performance (NIH toolbox measures of cognitive performance), mood (Profile of Mood States Questionnaire), and quality of life (PROMIS questionnaires of life satisfaction and the ability t...	These performance measures are questionnaires designed to collect information about downstream outcomes that are known to be associated with fatigue	Phase I: Cross-sectional only; Phase II: Baseline, Workday 1(beginning and end of shift) Workday 2 (beginning and end of shift), Workday 3 (beginning and end of shift)

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Alyson C. Ross, R.N., National Institutes of Health Clinical Center (CC)

Publications and helpful links

General Publications

• Caruso CC, Baldwin CM, Berger A, Chasens ER, Landis C, Redeker NS, Scott LD, Trinkoff A. Position statement: Reducing fatigue associated with sleep deficiency and work hours in nurses. Nurs Outlook. 2017 Nov-Dec;65(6):766-768. doi: 10.1016/j.outlook.2017.10.011. No abstract available.
• Caruso CC. Negative impacts of shiftwork and long work hours. Rehabil Nurs. 2014 Jan-Feb;39(1):16-25. doi: 10.1002/rnj.107. Epub 2013 Jun 18.
• Tahghighi M, Rees CS, Brown JA, Breen LJ, Hegney D. What is the impact of shift work on the psychological functioning and resilience of nurses? An integrative review. J Adv Nurs. 2017 Sep;73(9):2065-2083. doi: 10.1111/jan.13283. Epub 2017 Mar 27.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): May 22, 2019
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Nutrition; Sleep; Cognitive Performance; Shift Work
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 190035; 19-CC-0035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No