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临床试验/NCT01504750
NCT01504750已完成不适用

Healing Patient Rooms; The Effect of Lighting on Recovery and Well-being of Patients

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
196
试验地点
2
主要终点
Length of stay

研究概览

简要总结

Rationale:

Many study reports described benefits of natural sunlight. It is believed that artificial light can achieve similar benefits as sunlight and can be used to compensate for the lack of sunlight, for instance in north-facing hospital rooms or during wintertime.

The most plausible paths mediating the effects of light are:

  • the biological effect of light, relating to circadian biology and the sleep/wake-rhythm;
  • the emotional/psychological effects of light, relating to mood/stress and the antidepressant action of light .

Objective:

The project aims to measure, evaluate and quantify the beneficial effects of a dynamic daylight & atmosphere experience in patient rooms for cardiovascular patients during the dark months of the year.

Study design:

The study involves an experiment in which psychological, emotional and clinical parameters of patients in hospital rooms with standard light situation are compared with those of patients in rooms with a dynamic daylight & atmosphere experience.

Study population:

The population includes cardiovascular patients who reside in the general cardiology department of the Maastricht University Hospital (18 patient beds) with an intended minimum length of stay of 3 days, who have given written consent.

Intervention:

Half of the patient rooms on the ward are equipped with special luminaires. In the ceiling, luminaires are installed that offer the basic lighting in the patient room that will automatically and gradually change in light level (100-300 lux) and color temperature (3000-4000 K). This so called daily rhythm light meets the EN12464-1 standard for patient rooms in hospitals. The same luminaires in the ceiling will also offer the light boost by bringing the illuminance to a level of maximal 2000 lux and 7000 K, during a period of two hours in the morning. Besides the ceiling luminaires, a low intensity color cove as well as some white LED spots are added to create a pleasant ambience in the patient room

Main study parameters/endpoints:

The primary study measures are length of stay and quality of recovery expressed by physiological, emotional and clinical parameters. Also the effect on patient satisfaction is determined using pre and post assessments.

详细描述

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Regular measurements for patient care will be mainly used as outcome measures. Some of the psychological parameters are measured in regular care (e.g. pain score). Other psychological parameters will be measured with an additional questionnaire (depression, appetite, delirium, sleep quality and sleepiness). A trained research nurse will visit all participating patients in their rooms to assist with completing the questionnaires. This way of data collection will pose a minimal burden on the patients (maximum 30 minutes on daily basis). The risks of the intervention are negligible, because the light level will not exceed outside luminance on a cloudy day and meets all CIE safety standards (ref. CIE S009).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • patients admitted to study room

排除标准

  • Age under 18 years
  • Blindness
  • Unability to obtain informed consent

结局指标

主要结局

Length of stay

时间窗: participants will be followed for the duration of their stay at the cardiology ward (an expected average of 6 days) and one week thereafter

Does a dynamic daylight \& atmosphere experience improve the recovery of cardiovascular patients expressed in length of stay.

次要结局

  • general well-being(participants will be followed for the duration of their stay at the cardiology ward (an expected average of 6 days) and two weeks thereafter)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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