Healing Patient Rooms

NCT ID: NCT01504750

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-09-30

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).

Conditions

Depression; Headache; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

dynamic daylight and atmosphere lighting

Intervention Type: PROCEDURE

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.

control room

Normal lighted patient room

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients admitted to study room

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Lighting Eindhoven

UNKNOWN

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petra Kuijpers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

GOAL/HH/014/2009

Identifier Type: -

Identifier Source: org_study_id