Critical Illness
Conditions
Brief summary
Lack of sleep is a large problem for many patients in hospitals. Common causes are nuisances by light and sound. Especially with critically ill patients in the Intensive Care unit (ICU), Medium Care Unit (MCU) and Cardiac Care Unit (CCU), who are are monitored intensively, a lack of sleep often occurs. Patients with a lack of sleep more offer suffer from delirium, are more often anxious and stressed, and have a longer length of stay in the hospital. Also, patients' lack of sleep enhances nurses workloads during nightshifts. Because of this, there is a strong need for innovative devices which aim to limit the light and sound nuisances and thereby enhance patients' quality of sleep in the ICU, MC and CCU. The Maya is a special cover which can be placed over the head of the bed. As a result patients are able to limit light and sound nuisances and enhance their privacy. With this pilot-study we aim to determine: * The feasibility and experiences of patients and healthcare professionals with the Maya. * To determine the effect size of dependent variables which can be used in future studies.
Interventions
DEVICEMaya
The Maya is a cover which can be placed over the end of the patients bed. The Maya aims to reduce light and sound nuisances and enhance patients' privacy
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot study with a crossover design. Half of the patients will use the Maya on the first, third and fifth day of their admission and will not use the maya on the second fourth and sixth day (group 1). The other half will use the Maya on the second, fourth and sixth day of their admission and will not use the maya on the first, third and fifth day (group 2). Group allocation will be randomised.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult ICU, MC or CCU patients with 5 to 7 expected number of admission days * patients with an expected Richmond Agitation Sedation Scale (RASS) of \>-3 and \< +3 * patients who speak Dutch (because of the qualitative evaluation of the Maya)
Exclusion criteria
* patients with severe brain damage * patients with a severe psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of sleep | up to six days | patients' quality of sleep is measured once a day with the Richard Campbell Sleep Questionnaire (RCSQ); (minimum score 0 = worst sleep - maximum score 100 = best sleep) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS sleep | up to six days | Patients' sleep is measured once a day with the sleep numeric rating scale (NRS sleep); (minimum score 0 = worst sleep - maximum score 10 = best sleep) |
| Anxiety | up to six days | Patients' anxiety is measured once a day with the Daily Assesment of symptoms of Anxiety (DAS-A); (minimum score 0 = no anxiety - maximum score 24 = a lot of anxiety) |
| NRS Stress | up to six days | Patients' stress is measured once a day with the stress numeric rating scale (NRS-stress); (minimum score 0 = no stress - maximum score 10 = most imaginable stress) |
| Arousal | up to six days | patients' arousal is measured once a day with the Richmond Agitation Sedation Scale (RASS); (minimum score -5 = no reaction - maximum score = 4 very agitated) |
| Delirium CCU | up to six days | CCU patients' delirium is measured once a day with the delirium observation scale (DOSS); (minimum score 0 = no delirium; a score of \>= 3 means delirium; maximum score 65) |
| oxygen saturation | up to six days | Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage |
| Light | up to six days | Light level (LUX). This will be measured with a validated application on a mobile phone |
| Sound | up to six days | Sound levels (decibel). This will be measured with a validated application on a mobile phone |
| Hart rate | up to six days | hart rate is measured with a heart rate monitor and reported every two hours as beats per minute (BPM) |
| Respiratory rate | up to six days | Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute |
| Blood pressure | up to six days | Blood pressure is measured every two hours with a intra-arterial catheter or a bloodpressure cuff and reported as diastolic value and systolic value (mmHg) |
| Delirium ICU/MC | up to seven days | ICU/MC patients' delirium is measured once a day with the Intensive Care Delirium Checklist (ICDSC); (minimum score 0 = no delirium; a score of 1 - 3 means subsyndromal delirium; a score of 4 - 8 means delirium; maximum score 8) |
Contacts
Primary ContactBram Tilburgs, Dr.
Backup ContactMark van den Boogaard, Dr.
Outcome results
None listed