Healing Light Algorithms for Nurses in the ICU (ENGAGE-ICU)

Evaluation of the Effect on Nursing Care Specialists of a Device With Specific Light Algorithms to Maintain and Restore Circadian Melatonin Rhythmicity in Critically Ill Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Care; Phototherapy
• Intervention / Treatment: Device: Dynamic Light Therapy Device, LSA-1; Device: Dynamic Light Therapy Device, LSA-2; Device: Dynamic Light Therapy Device, LSA-3

Detailed Description

Circadian disruption affects most ICU patients and has far-reaching effects on organ functioning. One of the main factors driving negative outcomes among ICU patients is the lack of natural light. Light as a photoperiodic signal has a great impact on the regulation of the epiphyseal melatonin secretion and the entrainment of the day-night rhythm. This is investigated in the context of the Project HEaling LIght Algorithms for the ICU Patient (HELIA-ICU) a randomized controlled trial investigating the relationship between the treatment with a highly specialized light ceiling and the rhythmicity of melatonin levels and subsequently the decreased incidence of delirium in critically ill patients. For this, the light ceiling was installed in two patient treatment rooms. The current study (ENGAGE-ICU) investigates, in this context, the effects the installation of the highly specialized light ceiling on perceived stress and organization-related perceptions and attitudes among nursing care specialists working under the light ceiling.

The introduction of new elements to the workspace is assumed to have a twofold impact on nursing care specialists exposed to the light ceiling: on the one hand, the levels of illuminance will have an instrumental function, allowing a correct and efficient performance of tasks to the nursing care specialists, thus contributing to a reduction of their perceived levels of stress. On the other hand, the mere presence of the light ceiling will have a symbolic function, signaling the commitment of the organization toward patient welfare and innovation. This will impact attitudes toward the organization like commitment to the workplace and meaning of work. Furthermore, this symbolic function will likely also impact the feelings of empathy toward the patients among nursing care specialists.

Following their work schedules, nursing care specialists will be anonymously allocated into 4 treatment groups:

1. working the early shift in rooms with an operating light ceiling irradiating LSA-1 (high circadian effective irradiances + blue Light Intervention) or LSA-2 (high circadian effective irradiances without blue light intervention)
2. working the late or night shift in rooms with an operating light ceiling irradiating LSA-1 (high circadian effective irradiances + blue Light Intervention) or LSA-2 (high circadian effective irradiances without blue light intervention)
3. working in rooms with an operating light ceiling irradiating LSA-3 (standard irradiances)
4. working in conventional rooms, in which no light ceiling has been installed (Control Group).

Main Hypothesis:

Nursing care specialists working under increased irradiance lighting may differ in the perceived levels of stress compared with nursing care specialists working under conventional irradiance lighting.

Secondary Hypotheses:

1. Nursing care specialists working under increased irradiance lighting receiving illumination with increased irradiance and phases of Blue-Enriched White light (LSA-1) differ in the perceived levels of stress and report lower perceived stress compared with nursing care specialists working under conventional irradiance lighting (LSA-3).
2. Nursing care specialists working under increased irradiance lighting receiving illumination with increased irradiance without phases of Blue-Enriched White light (LSA-2) differ in the perceived levels of stress and report lower perceived stress compared with nursing care specialists working under conventional irradiance lighting (LSA-3).
3. Nursing care specialists working in rooms with a newly installed light ceiling differ in their self-reported commitment to the workplace compared with nursing care specialists working in rooms in which the light ceiling has not been installed.
4. Nursing care specialists working in rooms with a newly installed light ceiling differ in their self-reported meaning of work compared with nursing care specialists working in rooms in which the light ceiling has not been installed.
5. Nursing care specialists working in rooms with a newly installed light ceiling differ in their self-reported empathy compared with nursing care specialists working in rooms in which the light ceiling has not been installed.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Nursing care specialists

Description

Inclusion Criteria:

• All nursing care specialists working in ward 101i

Exclusion Criteria:

• Refusal to participate in the study

Termination criteria:

• Withdrawal from the study

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Dynamic Light Therapy
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; Dynamic Light Therapy
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; Dynamic Light Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Commitment to the Workplace	Assessed through the corresponding 2-item scale in the Copenhagen Psychosocial Questionnaire (COPSOQ). The higher the score the higher the self-reported commitment to the workplace (1 to 100)	April 2023 - April 2024
Meaning of Work	Assessed through the corresponding 2-item scale in the Copenhagen Psychosocial Questionnaire (COPSOQ). The higher the score the higher the self-reported perceived meaning of work (1 to 100)	April 2023 - April 2024
Empathy	Assessed through the corresponding 4-item scale of the Interpersonal Reactivity Index. The higher the score the higher the self-reported empathy (0 to 28)	April 2023 - April 2024

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Technische Universität Berlin

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 3000709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No