Characterizing Fatigue Experienced by Registered Nurses

NCT03789188 | Terminated

• 2 other identifiers: 19003519-CC-0035
• Study Type: observational
• Target: 313
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue

Keywords

Inflammation; Nutrition; Shift Work; Sleep; Cognitive Performance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• (Exploratory outcome) Clinical factors/Biomarkers associated with fatigue

  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...

  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)

Study Arms (1)

Healthy Volunteers

CC Registered Nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

registered nurses working in the National Institutes of Health Clinical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 29216975 BACKGROUND

• 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.

  PMID: 23780784 BACKGROUND

• 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.

  PMID: 28229469 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Fatigue; Inflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Alyson C. Ross, R.N.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 28, 2018
• Study Start: April 29, 2019
• Primary Completion: May 22, 2019
• Study Completion: September 1, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-09

Locations

US (1)