Status:
COMPLETED
Testing the Effectiveness of an Evening Blue-depleted Light Environment in an Acute Psychiatric Ward
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
Norwegian University of Science and Technology
Conditions:
Mental Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There is increasing recognition of the need to stabilize sleep-wake cycles in individuals with major mental disorders. As such, clinicians and researchers advocate for the use of interventions targete...
Detailed Description
In recent decades there has been increased attention to the impact of disturbed sleep on general health. For example, sleep-wake cycle abnormalities linked with circadian dysrhythmias are associated w...
Eligibility Criteria
Inclusion
- Individuals aged 18 years or older
- Admitted to the acute inpatient unit at St. Olavs University Hospital, Department Østmarka, Trondheim, Norway during the inclusion period for the study.
- Any patients who are re-admitted during the inclusion period for the study are eligible for re-randomization.
Exclusion
- Post-randomization, there are four potential reasons for exclusion from the RCT:
- Lack of availability of rooms (as allocated at randomization): acute wards operate at high levels of bed occupancy, so on some occasions there will be no rooms available in the ward to which the individual is allocated (i.e. the randomization process cannot be completed).
- Clinical imperative: on some occasions senior medical or nursing professionals may decide that it is clinically inappropriate to admit an individual to a vacant room in the ward to which they are randomized. The most frequent reasons for this to occur are clinical concerns about (a) how this admission would affect the case mix within the ward (e.g. it may be inappropriate to locate all the patients with an acute episode of mania in one ward, etc.) and/or (b) completing the randomization process may compromise the safety, care and treatment of current inpatients or of the individual being admitted (e.g. it may not be possible to provide the appropriate staff-to-patient ratio required for optimal treatment if all individuals with higher levels of need are located in one ward, etc.).
- The individual is unwilling to give written informed consent at any time during their admission (when approached according to the deferred consent procedure) or is unable to give informed consent for the duration of the study (i.e. they remain persistently and severely ill and/or lack mental capacity).
- The consent procedure was incomplete: an individual may be discharged early or have an unplanned discharge (e.g. discharge against medical advice) which may mean they were not approached about study participation or they had only given verbal, but not written consent.
- Withdrawal criteria:
- As randomization occurs at the point of admission, all exclusions de facto occur post-randomization, so the criteria described above represent the main reasons for study withdrawal.
- Additional withdrawal criteria:
- A patient will be withdrawn from the study if they are absent for \>24 hours from the ward to which they randomized (e.g. they may be transferred to a medical ward for several days; the patient may request or the clinicians instigate transfer to another ward; medical or nursing staff may decide the patient should be transferred to the other ward at the unit because of patient need, case mix or staffing issues, etc.).
- An individual can decline to participate at any stage of the study and/or a mental health professional can recommend withdrawal of an inpatient from the RCT if they have any clinical concerns regarding an individuals' participation (e.g. if there is a belief that the patient has experienced an adverse event associated with exposure to the blue-depleted light). In all instances a record will be kept of reasons for withdrawal.
Key Trial Info
Start Date :
October 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT03788993
Start Date
October 23 2018
End Date
December 1 2021
Last Update
March 8 2022
Active Locations (1)
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1
St. Olavs Hospital, Department Østmarka
Trondheim, Norway, 7040