DepressionNCT01504750
Healing Patient Rooms
A study testing dynamic daylight and atmosphere lighting in people with Depression and Headache, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Headache, Sleep
- What is being tested?
- dynamic daylight and atmosphere lighting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted to study room
Who cannot join
- Age under 18 years
- Blindness
- Unability to obtain informed consent
- Dementia
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, 6202 AZ
About this study
Official title: Healing Patient Rooms; The Effect of Lighting on Recovery and Well-being of Patients
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.
Read more
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.
Read the 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
- Being tested
- dynamic daylight and atmosphere lighting
- Keywords
- Length of Stay [E02.760.400.480], Activities of Daily Living [I03.050]
- Medical subject headings
- Depression, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic daylight and atmosphere lightingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| lighting room | Experimental | 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. Receives: Procedure: dynamic daylight and atmosphere lighting |
| control room | No intervention | Normal lighted patient room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Does a dynamic daylight \& atmosphere experience improve the recovery of cardiovascular patients expressed in length of stay.
Measured: 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 outcomes (1)
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?
Measured: participants will be followed for the duration of their stay at the cardiology ward (an expected average of 6 days) and two weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Lighting Eindhoven
- Responsible party
- Sponsor
- Investigators
- Petra Kuijpers, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504750
- Sponsor's protocol ID
- GOAL/HH/014/2009
- Status last verified
- Jan 2012
- First submitted
- 14 Nov 2011
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Patient Rooms; The Effect of Lighting on Recovery and Well-being of Patients
- ClinicalTrials.gov ID
- NCT01504750
- Acronym / sponsor ID
- GOAL/HH/014/2009
- Conditions
- Depression, Headache, Sleep
- Keywords
- Length of Stay [E02.760.400.480], Activities of Daily Living [I03.050]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Philips Lighting Eindhoven
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lighting room | Experimental | Procedure: dynamic daylight and atmosphere lightingIn 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. |
| control room | No intervention | –Normal lighted patient room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted to study room
Key exclusion criteria (4 listed)
- Age under 18 years
- Blindness
- Unability to obtain informed consent
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic daylight and atmosphere lightingIn 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. | Procedure or surgery | lighting room |
Primary outcome
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
Does a dynamic daylight \& atmosphere experience improve the recovery of cardiovascular patients expressed in length of stay.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Kuijpers, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic daylight and atmosphere lighting in people with Depression and Headache, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.