NCT06829979

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 23, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 21, 2026

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

February 11, 2025

Last Update Submit

January 18, 2026

Conditions

Keywords

SleepFatigueBurnoutNight shift

Outcome Measures

Primary Outcomes (4)

  • Recruitment rate

    Number of potential participants screened in order to enroll 8 participants

    2 months

  • Attrition rate

    Percentage of enrolled participants completing the intervention as a whole and its three conditions

    4 months

  • Completeness of questionnaire responses

    Percentage of completed responses

    4 months

  • Melatonin collection

    Number of salivary melatonin samples collected

    4 months

Secondary Outcomes (12)

  • Changes in physical health between baseline and the three conditions

    3 months

  • Changes in mental health between baseline and the three conditions

    3 months

  • Changes in Multidimensional Sleep Health between baseline and the three conditions

    3 months

  • Changes in sleep distrubance between baseline and the three conditions

    3 months

  • Changes in sleep-related impairment between baseline and the three conditions

    3 months

  • +7 more secondary outcomes

Study Arms (1)

Single group, crossover - order of the interventions to be randomly selected

EXPERIMENTAL

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: * Napping/relaxation room, blue and green light blocking glasses, combined * Blue and green light blocking glasses, napping/relaxation room, combined * Napping/relaxation room, combined, blue and green light blocking glasses * Blue and green light blocking glasses, combined, napping/relaxation room * Combined, napping/relaxation room, blue and green light blocking glasses * Combined, blue and green light blocking glasses, napping/relaxation room

Behavioral: Access to napping/relaxation roomOther: Blue and green light blocking glasses

Interventions

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.

Single group, crossover - order of the interventions to be randomly selected

During the night shift, participants will be asked wear study-provided blue and green light blocking glasses.

Single group, crossover - order of the interventions to be randomly selected

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

FatigueBurnout, Psychological

Interventions

RID

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants are in a single group/cohort. Everyone will receive the same interventions in the same order. The order of the interventions will be randomly selected from six possible choices.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

May 23, 2025

Primary Completion

October 29, 2025

Study Completion

December 31, 2025

Last Updated

January 21, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Final data sets from the research may be shared.

Access Criteria
A Limited Dataset (LDS) may be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Locations