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Healing Patient Rooms

Primary Purpose

Depression, Headache, Sleep

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
dynamic daylight and atmosphere lighting
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Length of Stay [E02.760.400.480], Activities of Daily Living [I03.050]

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- patients admitted to study room

Exclusion Criteria:

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

lighting room

control room

Arm Description

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.

Normal lighted patient room

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

general well-being
Does a dynamic daylight & atmosphere experience increase the general well-being (sleepiness/alertness, cognitive functioning, sleep quality and appetite) and satisfaction of cardiovascular patients?

Full Information

First Posted
November 14, 2011
Last Updated
January 5, 2012
Sponsor
Maastricht University Medical Center
Collaborators
Philips Lighting Eindhoven
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1. Study Identification

Unique Protocol Identification Number
NCT01504750
Brief Title
Healing Patient Rooms
Official Title
Healing Patient Rooms; The Effect of Lighting on Recovery and Well-being of Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Philips Lighting Eindhoven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Headache, Sleep
Keywords
Length of Stay [E02.760.400.480], Activities of Daily Living [I03.050]

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lighting room
Arm Type
Experimental
Arm Description
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.
Arm Title
control room
Arm Type
No Intervention
Arm Description
Normal lighted patient room
Intervention Type
Procedure
Intervention Name(s)
dynamic daylight and atmosphere lighting
Intervention Description
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 system offers a 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, a low intensity color cove as well as some white LED spots are added to create a pleasant ambience in the patient room. The illuminance is between 50 and 60 lux and, depending on the color choice, the color temperature is 2300 K (relax) or 3800 K (active). The lighting solution used is HealWell of Philips Lighting.
Primary Outcome Measure Information:
Title
Length of stay
Description
Does a dynamic daylight & atmosphere experience improve the recovery of cardiovascular patients expressed in length of stay.
Time Frame
participants will be followed for the duration of their stay at the cardiology ward (an expected average of 6 days) and one week thereafter
Secondary Outcome Measure Information:
Title
general well-being
Description
Does a dynamic daylight & atmosphere experience increase the general well-being (sleepiness/alertness, cognitive functioning, sleep quality and appetite) and satisfaction of cardiovascular patients?
Time Frame
participants will be followed for the duration of their stay at the cardiology ward (an expected average of 6 days) and two weeks thereafter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - patients admitted to study room Exclusion Criteria: Age under 18 years Blindness Unability to obtain informed consent Dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Kuijpers, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

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Healing Patient Rooms

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