Mental Illness
Conditions
Keywords
Lighting, Inpatients, Recovery, Sleep
Brief summary
The purpose of this pilot study is to evaluate wether a naturalistic indoor light environment can improve sleep and mood in psychiatric inpatients
Detailed description
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.
Interventions
OTHERDynamic lighting
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
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* Admission
Exclusion criteria
* Inability to provide written consent * Mania
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Qualitative assessment using a custom made questionnaire | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months | Number of patients with side-effects. |
| Sleep diary | Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of medication from logged activity in the electronic medical record | Assessed through study completion, an average of 1 month, up to 6 months | Use of medication during admission including drug og dosages administered to the participants in mg/day. |
| Involuntary restraints | Assessed through study completion, an average of 1 month, up to 6 months | Number of participants who experienced involuntary physical and/or medical restraints. |
| Time to discharge | Assessed through study completion, an average of 1 month, up to 6 months | Number of days between admission and discharge |
Countries
Denmark
Outcome results
None listed