Characterizing Fatigue Experienced by Registered Nurses
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | October 20, 2022 |
| Contact: | Brenda D Roberson, R.N. |
| Email: | broberson@mail.nih.gov |
| Phone: | (301) 594-5321 |
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.
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.
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).
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).
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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