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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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The purpose of this pilot study is to evaluate wether a naturalistic indoor light environment can improve sleep and mood in psychiatric inpatients
Setting: 17 bed inpatient ward at a University Mental Health Hospital
Rooms: The dimensions of all 17 rooms are identical with 4,54m x 3,14m, ceiling height 3,15m, a window, a bed, a table, a chair and a bathroom 1,55m x 1,85m.
Assignment of interventions: After admission patients are invited to participate in the study. If the patients wish to participate they will go through eligibility screen, sign informed consent and fill out questionnaires on sleep, mood and well-being (-t1). The patients (now participants) are randomly allocated (t0) by sealed envelope technique and the envelope is brought to the staff office and opened by a staff member who then from the computer in the office programs the participant's room to either intervention or control.
Randomization: The investigators used random permuted blocks of varying and blinded block size. A third party person created the envelopes and arranged them in blocks.
Blinding: The outcome assessor and data analyst is blinded to allocation. Trial participants and care providers are unblinded. Participants may be replaced to another room for practical, clinical reasons. In this case, the intervention/control conditions will follow the patient.
Data management: All data will be entered in RedCAP and stored in a electronic online secured database at Aarhus University.
Power estimation: Alfa: 0.05. Beta: 0.20. Effect size: change of 4 points in PSQI with a standard deviation estimated to 4. Number of patients in each arm: 17 (x 2 = 34). Number needed to be included accounting for discontinuation: 60 (estimated)
Statistics: The investigators will calculate intention-to-treat. Other statistical analyses will include logistic regression for dichotomous outcome data, analysis of covariance for continuous outcome data, and survival analysis for time-to-event outcome data. Interim-analyses during the data-collection period to stop trial if intervention produces larger than expected benefits or harm or if investigators find evidence of no important difference between experimental and control interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic lighting | Experimental | Indoor lighting with low-lux no-blue wavelengths at night. |
|
| Treatment as usual | No Intervention | Characterized by full white light with little variation through a day cyclus. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic lighting | Other | Intervention is rooms with light settings imitating natural light conditions with white light at day and low-lux no-blue light at night: 07am-10am: white light, increasing intensity 10am-07pm: white light, full intensity 07pm-11pm: no blue wavelength, low intensity 11pm-07am: no blue wavelength, very low intensity |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality on the Pittsburgh Sleep Quality Index (PSQI) | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms on the Major depression inventory (MDI) | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months | |
| Well-being on the World Health Organization measure of well-being (WHO-5) | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge | Number of days between admission and discharge | Assessed through study completion, an average of 1 month, up to 6 months |
| Involuntary restraints | Number of participants who experienced involuntary physical and/or medical restraints. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Okkels, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Affective Disorders, Aarhus University Hospital, Risskov | Risskov | Jylland | 8240 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23711982 | Background | Bedrosian TA, Nelson RJ. Influence of the modern light environment on mood. Mol Psychiatry. 2013 Jul;18(7):751-7. doi: 10.1038/mp.2013.70. Epub 2013 May 28. | |
| 24917305 | Background | LeGates TA, Fernandez DC, Hattar S. Light as a central modulator of circadian rhythms, sleep and affect. Nat Rev Neurosci. 2014 Jul;15(7):443-54. doi: 10.1038/nrn3743. Epub 2014 Jun 11. |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008029 | Lighting |
| ID | Term |
|---|---|
| D004780 | Environment, Controlled |
| D004777 | Environment |
| D004778 | Environment and Public Health |
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| Qualitative assessment using a custom made questionnaire | Number of patients with side-effects. | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months |
| Sleep diary | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months |
| Assessed through study completion, an average of 1 month, up to 6 months |
| Use of medication from logged activity in the electronic medical record | Use of medication during admission including drug og dosages administered to the participants in mg/day. | Assessed through study completion, an average of 1 month, up to 6 months |