NCT05949827

Brief Summary

The purpose of this study is to investigate the impact of a newly installed device administering a Light Scheduling Algorithm with high circadian effective irradiances to mechanically ventilated patients on the perceived stress among nursing care specialists. The investigators will further evaluate the impact on commitment to the workplace, meaning of work, and empathy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

1.5 years

First QC Date

July 10, 2023

Last Update Submit

June 12, 2024

Conditions

Critical CarePhototherapy

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress

    Assessed through the single-item Perkhofer Stress Scale. The higher the score the higher the perceived stress (1 to 10)

    April 2023 - April 2024

Secondary Outcomes (3)

  • Commitment to the Workplace

    April 2023 - April 2024

  • Meaning of Work

    April 2023 - April 2024

  • Empathy

    April 2023 - April 2024

Study Arms (3)

Active Comparator: LSA-1

Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances + Blue Enriched Light episodes

Device: Dynamic Light Therapy Device, LSA-1

Active Comparator: LSA-2

Light Scheduling Algorithm-2 (LSA-2): High circadian effective irradiances without Blue Enriched Light episodes.

Device: Dynamic Light Therapy Device, LSA-2

Active Comparator: LSA-3

Light Scheduling Algorithm-3 (LSA-3): Irradiance levels comparable to conventional hospital lighting (control group).

Device: Dynamic Light Therapy Device, LSA-3

Interventions

Dynamic Light Therapy Device, LSA-1DEVICE

Dynamic Light Therapy

Active Comparator: LSA-1
Dynamic Light Therapy Device, LSA-2DEVICE

Dynamic Light Therapy

Active Comparator: LSA-2
Dynamic Light Therapy Device, LSA-3DEVICE

Dynamic Light Therapy

Active Comparator: LSA-3

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nursing care specialists

You may qualify if:

  • All nursing care specialists working in ward 101i

You may not qualify if:

  • Refusal to participate in the study
  • Termination criteria:
  • Withdrawal from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

June 1, 2023

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations

DE(1)