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临床试验/NCT02653040
NCT02653040已完成不适用

Light as an Aid for Recovery in Psychiatric Inpatients: A Pragmatic Randomized Controlled Pilot Trial

University of Aarhus2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Sleep quality on the Pittsburgh Sleep Quality Index (PSQI)

研究概览

简要总结

The purpose of this pilot study is to evaluate wether a naturalistic indoor light environment can improve sleep and mood in psychiatric inpatients

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission

排除标准

  • Inability to provide written consent

研究组 & 干预措施

Dynamic lighting

Experimental

Indoor lighting with low-lux no-blue wavelengths at night.

干预措施: Dynamic lighting (Other)

Treatment as usual

No Intervention

Characterized by full white light with little variation through a day cyclus.

结局指标

主要结局

Sleep quality on the Pittsburgh Sleep Quality Index (PSQI)

时间窗: Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months

次要结局

  • Qualitative assessment using a custom made questionnaire(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)
  • 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)
  • Sleep diary(Answers from questionnaires are assessed through study completion, an average of 1 month, up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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