Improving Sleep and Reducing External Stimuli With the Maya
- Conditions
- Critical Illness
- Interventions
- Device: Maya
- Registration Number
- NCT05078645
- Lead Sponsor
- Radboud University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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)
- patients with severe brain damage
- patients with a severe psychiatric disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1: Maya use on 1st, 3th and 5th day Maya Group 1 uses the Maya on the 1st, 3th and 5th day and not on the 2nd, 4th and 6th day of their admission to either the ICU, MC or CCU. Group 2: Maya use on the 2nd, 4th, and 6th day Maya Group 2 uses the Maya on the 2nd, 4th and 6th day and not on the 1st, 3th, and 5th day of their admission to either the ICU, MC or CCU.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Respiratory rate up to six days Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute
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)
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)
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)
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)
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)
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)
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)
Light up to six days Light level (LUX). This will be measured with a validated application on a mobile phone
oxygen saturation up to six days Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage