Characterizing Fatigue Experienced by Registered Nurses
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|ClinicalTrials.gov Identifier: NCT03789188|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : November 15, 2019
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.
To learn more about how fatigue affects registered nurses.
RNs at least 18 years old who work at NIH
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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||460 participants|
|Official Title:||Characterizing Fatigue Experienced by Registered Nurses|
|Estimated Study Start Date :||November 20, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||October 20, 2022|
CC Registered Nurses
- Fatigue - as measured by the Multidimensional Fatigue Symptom Inventory (MFSI) and the Occupational Fatigue Exhaustion Recovery Scale (OFER) [ Time Frame: 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 the shift) ]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
- (Exploratory outcome) Clinical factors/Biomarkers associated with fatigue [ Time Frame: Phase II: Baseline and workday yhree (end of shift) ]Exploratory biomarkers potentially related to fatigue that will be examined will include orthostatic blood pressure (measure of autonomic function) and inflammatory biomarkers (hs-CRP, TNF-, IL-6, IL1-beta, and GlycA)
- "Performance" outcomes associated with fatigue: cognitive performance, mood, and quality of life. See Secondary Outcome description for more details. [ Time Frame: 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 the shift) ]Secondary Outome: "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 abilityto fulfill social roles/activities.These performance measures are questionnaires designed to collect information about downstream outcomes that are known to be associated with fatigue
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789188
|Contact: Brenda D Roberson, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Alyson C. Ross, R.N.||National Institutes of Health Clinical Center (CC)|