Critical CareENGAGE-ICUNCT05949827
Healing Light Algorithms for Nurses in the ICU
An observational study of Critical Care and Phototherapy, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Critical Care, Phototherapy
- What is being tested?
- Dynamic Light Therapy Device, LSA-1, Dynamic Light Therapy Device, LSA-2 and Dynamic Light Therapy Device, LSA-3
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nursing care specialists
Who may be able to join
- All nursing care specialists working in ward 101i
Who cannot join
- Refusal to participate in the study
- Termination criteria:
- Withdrawal from the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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)
- 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)
- working in rooms with an operating light ceiling irradiating LSA-3 (standard irradiances)
- 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:
- 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).
- 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).
- 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.
- 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.
- 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.
- Conditions
- Critical Care, Phototherapy
- Being tested
- Dynamic Light Therapy Device, LSA-1, Dynamic Light Therapy Device, LSA-2, Dynamic Light Therapy Device, LSA-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Light Therapy Device, LSA-1Device
Dynamic Light Therapy
Dynamic Light Therapy Device, LSA-2Device
Dynamic Light Therapy
Dynamic Light Therapy Device, LSA-3Device
Dynamic Light Therapy
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: LSA-1 | Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances + Blue Enriched Light episodes Receives: 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. Receives: 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). Receives: Device: Dynamic Light Therapy Device, LSA-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress
Assessed through the single-item Perkhofer Stress Scale. The higher the score the higher the perceived stress (1 to 10)
Measured: April 2023 - April 2024
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: April 2023 - April 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jun 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Berlin
- Responsible party
- Principal investigator, Alawi Luetz, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949827
- Sponsor's protocol ID
- 3000709
- Acronym
- ENGAGE-ICU
- Status last verified
- Jun 2024
- First submitted
- 10 Jul 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05949827
- Acronym / sponsor ID
- ENGAGE-ICU / 3000709
- Conditions
- Critical Care, Phototherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Technische Universität Berlin
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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)
- 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)
- working in rooms with an operating light ceiling irradiating LSA-3 (standard irradiances)
- 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:
- 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).
- 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).
- 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.
- 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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: LSA-1 | – | Device: Dynamic Light Therapy Device, LSA-1Light Scheduling Algorithm-1 (LSA-1): High circadian effective irradiances + Blue Enriched Light episodes |
| Active Comparator: LSA-2 | – | Device: Dynamic Light Therapy Device, LSA-2Light Scheduling Algorithm-2 (LSA-2): High circadian effective irradiances without Blue Enriched Light episodes. |
| Active Comparator: LSA-3 | – | Device: Dynamic Light Therapy Device, LSA-3Light Scheduling Algorithm-3 (LSA-3): Irradiance levels comparable to conventional hospital lighting (control group). |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nursing care specialists
Key inclusion criteria (1 listed)
- All nursing care specialists working in ward 101i
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Withdrawal from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Light Therapy Device, LSA-1Dynamic Light Therapy | Device | Active Comparator: LSA-1 |
| Dynamic Light Therapy Device, LSA-2Dynamic Light Therapy | Device | Active Comparator: LSA-2 |
| Dynamic Light Therapy Device, LSA-3Dynamic Light Therapy | Device | Active Comparator: LSA-3 |
Primary outcome
Perceived Stress
Time frame: April 2023 - April 2024
Assessed through the single-item Perkhofer Stress Scale. The higher the score the higher the perceived stress (1 to 10)
3 secondary outcomes
Commitment to the Workplace
Time frame: April 2023 - April 2024
Meaning of Work
Time frame: April 2023 - April 2024
Empathy
Time frame: April 2023 - April 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care and Phototherapy, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress (time frame: April 2023 - April 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.