Healing Patient Rooms

This study has been completed.
Sponsor:
Collaborator:
Philips Lighting Eindhoven
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01504750
First received: November 14, 2011
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Depression
Headache
Sleep
Procedure: dynamic daylight and atmosphere lighting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Healing Patient Rooms; The Effect of Lighting on Recovery and Well-being of Patients

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Does a dynamic daylight & atmosphere experience improve the recovery of cardiovascular patients expressed in length of stay.


Secondary Outcome Measures:
  • general well-being [ 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 ] [ Designated as safety issue: No ]
    Does a dynamic daylight & atmosphere experience increase the general well-being (sleepiness/alertness, cognitive functioning, sleep quality and appetite) and satisfaction of cardiovascular patients?


Enrollment: 196
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lighting room
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.
Procedure: dynamic daylight and atmosphere lighting
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.
No Intervention: control room
Normal lighted patient room

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- patients admitted to study room

Exclusion Criteria:

  • Age under 18 years
  • Blindness
  • Unability to obtain informed consent
  • Dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504750

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Philips Lighting Eindhoven
Investigators
Principal Investigator: Petra Kuijpers, MD, PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01504750     History of Changes
Other Study ID Numbers: GOAL/HH/014/2009
Study First Received: November 14, 2011
Last Updated: January 5, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Length of Stay [E02.760.400.480]
Activities of Daily Living [I03.050]

Additional relevant MeSH terms:
Depression
Depressive Disorder
Headache
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014