- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06829979
Improving Night Shift Nurses' Health and Reducing Burnout
A Pilot, Feasibility Study to Improve Night Shift Nurses' Health and Reduce Burnout
Healthy and happy nurses are essential to ensuring optimal patient outcomes and organizational success. The evidence on the negative impacts of night shift on nurses' health and cognitive function, and their implications on patient outcomes and organizational costs, reflect the need for interventions to mitigate these detrimental outcomes.
This pilot, feasibility, clinical trial will examine the feasibility of two fatigue countermeasure interventions (access to napping/relaxation room and use of blue/green light blocking glass during night shift) and explore the interventions effects on nurses' health, missed care, and burnout.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim 1 (Primary): Examine the feasibility of a larger study and hospital-wide implementation of two fatigue countermeasure interventions (access to napping/relaxation rooms and use of blue/green light blocking glass during night shift).
Aim 2 (Exploratory): Explore the effects of the interventions on melatonin levels, overall health, sleep, fatigue, cognitive function, missed care, nurse burnout, and salivary melatonin levels.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- UPMC Shadyside
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a registered nurse at UPMC Shadyside (Pittsburgh, PA)
- Working full-time night or rotating shifts
- Willing to wear a Fitbit around-the-clock during the study
- Willing to use nap/relaxation room and glasses only when assigned to that condition
- Willing to provide saliva samples
Exclusion Criteria:
- Having a diagnosed sleep disorder (e.g., obstructive sleep apnea, insomnia, restless leg syndrome, or shift work disorder)
- Currently being treated for a serious mental illness
- Needing to use eye glasses to complete work related activities (note: contact lenses are acceptable)
- Use of prescription or over-the-counter sleep aides including melatonin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single group, crossover - order of the interventions to be randomly selected
All participants will receive the same interventions which includes access to the napping/relaxation room only intervention, blue and green light blocking glasses only intervention, and the combined intervention. There will be a two-week washout between the interventions. The order of the interventions will be randomized to one of the following options:
|
During the night shift, study participants will have access to the hospital unit's napping/relaxation room with a sound machine, diffusers for aromatherapy, a massage chair that can be used for napping, and snacks.
During the night shift, participants will be asked wear study-provided blue and green light blocking glasses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment rate
Time Frame: 2 months
|
Number of potential participants screened in order to enroll 8 participants
|
2 months
|
|
Attrition rate
Time Frame: 4 months
|
Percentage of enrolled participants completing the intervention as a whole and its three conditions
|
4 months
|
|
Completeness of questionnaire responses
Time Frame: 4 months
|
Percentage of completed responses
|
4 months
|
|
Melatonin collection
Time Frame: 4 months
|
Number of salivary melatonin samples collected
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in physical health between baseline and the three conditions
Time Frame: 3 months
|
Changes the in PROMIS Global Health 10-item Measure, Physical Health sub-scale T-score. T-score ranges from 16.2 to 67.7 with 50.0 (standard deviation of 10) being the population mean. Higher scores represent better physical health. |
3 months
|
|
Changes in mental health between baseline and the three conditions
Time Frame: 3 months
|
Changes the in PROMIS Global Health 10-item Measure, Mental Health sub-scale T-score. T-score ranges from 21.2 to 67.6 with 50.0 (standard deviation of 10) being the population mean. Higher scores represent better mental health. |
3 months
|
|
Changes in Multidimensional Sleep Health between baseline and the three conditions
Time Frame: 3 months
|
Changes in RSATED survey scores Total score ranges from 0 to 12 with higher scores representing better sleep health.
|
3 months
|
|
Changes in sleep distrubance between baseline and the three conditions
Time Frame: 3 months
|
Changes in PROMIS Sleep Disturbance 8-item Measure T-scores. T-score ranges from 28.9 to 76.5.7 with 50.0 (standard deviation of 10) being the population mean. Higher scores represent more sleep disturbances. |
3 months
|
|
Changes in sleep-related impairment between baseline and the three conditions
Time Frame: 3 months
|
Changes in PROMIS Sleep-related Impairment 8-item Measure T-scores.
T-score ranges from 30.2 to 80.1 with 50.0 (standard deviation of 10) being the population mean.
Higher scores represent more sleep-related impairment.
|
3 months
|
|
Change in sleep duration between baseline and the three conditions
Time Frame: 3 months
|
Change in mean actigraphic sleep duration
|
3 months
|
|
Change in sleep efficiency between baseline and the three conditions
Time Frame: 3 months
|
Change in mean actigraphic sleep efficiency
|
3 months
|
|
Change in fatigue between baseline and the three conditions
Time Frame: 3 months
|
Change in PROMIS Fatigue 7-item Measure T-scores.
T-score ranges from 29.4 to 83.2 with 50.0 (standard deviation of 10) being the population mean.
Higher scores represent more fatigue.
|
3 months
|
|
Change in cognition function between baseline and the three conditions
Time Frame: 3 months
|
Change in PROMIS Cognitive Function 8-item Measure T-scores.
T-score ranges from 22.41 to 83.2 with 63.48 (standard deviation of 10) being the population mean.
Higher scores represent better cognitive function.
|
3 months
|
|
Change in burnout between baseline and the three conditions
Time Frame: 3 months
|
Change in Copenhagen Burnout Inventory scores.
The Copenhagen Burnout Inventory has three sub-scales measuring personal burnout, work-related burnout, and client-related burnout.
Sub-scales scores range from 0 to 100 with higher scores representing greater burnout.
|
3 months
|
|
Changes in missed care between baseline and the three conditions
Time Frame: 3 months
|
Changes in Tasks Undone-12 Scale scores.
Scores range from 0 to 12 with higher scores representing more undone nursing tasks.
|
3 months
|
|
Changes in salivary melatonin levels between baseline and the three conditions
Time Frame: 3 months
|
Changes in salivary melatonin levels
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY24090069
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Access to napping/relaxation room
-
University of New MexicoCompleted
-
University of AgderStiftelsen Helse og Rehabilitering; Nasjonalforeningen for folkehelsenCompletedBody Composition | Physical Activity Level | Bicycling Distance | Bicycling Time | Cardiorespratory FitnessNorway
-
Jagiellonian UniversityCompletedTEMPOROMANDIBULAR JOINT DYSFUNCTION SYNDROME
-
Istanbul University - CerrahpasaRecruitingPre-Eclampsia | Maternal Health | Virtual Reality | Relaxation | Fetal MonitoringTurkey (Türkiye)
-
Catharina Ziekenhuis EindhovenUnknownObesity | Telemedicine | Bariatric SurgeryNetherlands
-
Odense University HospitalCompletedHealth Knowledge, Attitudes, Practice | Downs SyndromeDenmark
-
Memorial University of NewfoundlandCompletedMultiple Sclerosis | Rehabilitation | Gait Disorders, Neurologic | Neuronal PlasticityCanada
-
Ondokuz Mayıs UniversityCompletedMultiple Sclerosis | Fatigue | SleepTurkey
-
Providence VA Medical CenterUS Department of Veterans AffairsUnknownVeterans | Nursing Home | Quality of Care | Functional Impairment
-
Rennes University HospitalUnknownAdult Asylum Seekers Who Have Applied for Asylum at the Regional Prefecture in RennesFrance