ENGAGE-ICU: Healing Light Algorithms for Nurses in the ICU

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT05949827
Collaborator
Technische Universität Berlin (Other)
80
1
6
13.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Perceived Stress [April 2023 - April 2024]

    Assessed through the single-item Perkhofer Stress Scale. The higher the score the higher the perceived stress

Secondary Outcome Measures

  1. Commitment to the Workplace [April 2023 - April 2024]

    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

  2. Meaning of Work [April 2023 - April 2024]

    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

  3. Empathy [April 2023 - April 2024]

    Assessed through the corresponding 4-item scale of the Interpersonal Reactivity Index. The higher the score the higher the self-reported empathy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All nursing care specialists working in ward 101i
Exclusion Criteria:
  • Refusal to participate in the study
Termination criteria:
  • Withdrawal from the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité - Universitätsmedizin Berlin Berlin Germany 10117

Sponsors and Collaborators

  • Charite University, Berlin, Germany
  • Technische Universität Berlin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alawi Luetz, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT05949827
Other Study ID Numbers:
  • 3000709
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 18, 2023