No registrations found.
ID
Source
Brief title
Health condition
Intensive chemotherapy, intensieve chemotherapie, AML, ALL, Burkitt lymphoma, Burkitt lymfoom, mantle cell lymphoma, mantelcellymfoom, multiple myeloma, multipel myeloom
Sponsors and support
TNO
TNO
Intervention
Outcome measures
Primary outcome
Difference in wakefullness during the time presumed sleeping between both groups.
Secondary outcome
1. Subjective quality of sleep;
2. Depression;
3. Delirium as diagnosed by a psychiatrist;
4. Clinical parameters (complications, blood pressure, heart rate, temperature, pain score);
5. Duration of hospitalization;
6. Medication with special attention to benzodiazepines, antipsychotics, antidepressants, corticosteroids, and other medication with known psychiatric side effect (such as voriconazole).
Background summary
N/A
Study objective
Artificial dynamic lightening can positively influence the sleep/wake cycle and reduce the disturbance of the circadian rhythm due to hospitalization.
Study design
Enrolment (demographic data, medical diagnosis, medication, sleep pattern by Municher Chronotype Questionaire, global clinical impression by staff).
During study:
1. Continuous:
Actigraphy by actiwatch, environmental parameters ie vertical and horizontal illuminance levels (due to daylight and/or artificial light), use of sunscreens and/or curtains, use and adjustment by patients/staff of all lighting systems in the room, room temperature, room humidity, position patient (bed or chair), outdoor vertical and horizontal illuminance levels;
2. Once daily:
Heart rate, blood pressure, temperature, quality of sleep (Groninger Sleep Quality Scale);
3. Two times per week:
Pain scored by numeric rating scale (NRS);
4. Weekly:
Hospital anxiety depression scale (HADS), delirium (as weekly revised by a psychiatrist), complications (as noted in the decursus), use of benzodiazepines, antipsychotics, antidepressants, corticosteroids, other medication, WHO performance score, frequency and duration of swith off the study light due to medical reasons or on patients request;
5. Once during admission:
Evaluation of lighting system itself by patients;
6. Periodical:
Noise, ventilation, air flow;
7. At the end of the study:
Global clinical impression by staff, length of stay;
8. In case of early cessation of patient participation:
Reason of cessation;
9. At the end of the entire study period:
Evaluation of lighting system by staff.
Intervention
On the haematology ward of the hospital, 9 single-bed rooms will be equipped with dynamic light as well as standard light. The design of the study is a randomized controlled trial. Patients will be randomized to dynamic light or standard light for their entire stay. If during a subsequent stay (ie second episode) patients participate again, they will be switched to the opposite condition.
HV 217<br>
Postbus 2040
M.E. Heel, de
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033440
m.vanheel@erasmusmc.nl
HV 217<br>
Postbus 2040
M.E. Heel, de
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033440
m.vanheel@erasmusmc.nl
Inclusion criteria
1. Patient at least 18 yrs old;
2. Admitted to the haematology dept in a private patient room equipped with dynamic light as well as standard light;
3. Written informed consent;
4. Expected length of stay approx 3 weeks with room arrest;
5. Patients requiring intensive chemotherapy, due to AML, ALL, Burkitt lymphoma, mantle cell lymphoma, and multiple myeloma.
Exclusion criteria
1. Active depression;
2. Visual handicapped due to ocular pathologies like macula degeneration, severe cataract or severe diabetic retinopathy;
3. Sleep apnoe syndrome;
4. Extreme light sensitivity;
5. Insufficient fluency in Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3069 |
| NTR-old | NTR3217 |
| Other | METC Erasmusmc : 2011-174 |