Healing Light Algorithms for Nurses in the ICU

Critical Care Clinical Trial

— ENGAGE-ICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949827
• Other study ID #: 3000709
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: Charite University, Berlin, Germany
• Contact: Alawi Luetz, Prof. Dr.
• Phone: +49 30 450631208
• Email: alawi.luetz[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• All nursing care specialists working in ward 101i

Exclusion Criteria:

• Refusal to participate in the study

Termination criteria:

• Withdrawal from the study

Related Conditions & MeSH terms

• Critical Care
• Phototherapy

Intervention

Device:
• Dynamic Light Therapy Device, LSA-1
Dynamic Light Therapy
• Dynamic Light Therapy Device, LSA-2
Dynamic Light Therapy
• Dynamic Light Therapy Device, LSA-3
Dynamic Light Therapy

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Technische Universität Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress	Assessed through the single-item Perkhofer Stress Scale. The higher the score the higher the perceived stress	April 2023 - April 2024
Secondary	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	April 2023 - April 2024
Secondary	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	April 2023 - April 2024
Secondary	Empathy	Assessed through the corresponding 4-item scale of the Interpersonal Reactivity Index. The higher the score the higher the self-reported empathy	April 2023 - April 2024