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Improving Sleep and Reducing External Stimuli With the Maya
Improving Sleep and Reducing External Stimuli With the Maya: a Pilot Study on Experience, Feasibility and Applicability
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.
Studie Overzicht
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Bram Tilburgs, Dr.
- Telefoonnummer: 0031 24 36155618
- E-mail: bram.tilburgs@radboudumc.nl
Studie Contact Back-up
- Naam: Mark van den Boogaard, Dr.
- Telefoonnummer: 0031 24 36155618
- E-mail: mark.vandenboogaard@radboudumc.nl
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: Group 1: Maya use on 1st, 3th and 5th day
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.
|
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
|
Ander: Group 2: Maya use on the 2nd, 4th, and 6th day
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.
|
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Quality of sleep
Tijdsspanne: 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)
|
up to six days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
NRS sleep
Tijdsspanne: 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)
|
up to six days
|
Anxiety
Tijdsspanne: 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)
|
up to six days
|
NRS Stress
Tijdsspanne: 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)
|
up to six days
|
Arousal
Tijdsspanne: 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)
|
up to six days
|
Delirium CCU
Tijdsspanne: 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)
|
up to six days
|
Delirium ICU/MC
Tijdsspanne: 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)
|
up to seven days
|
Light
Tijdsspanne: up to six days
|
Light level (LUX).
This will be measured with a validated application on a mobile phone
|
up to six days
|
Sound
Tijdsspanne: up to six days
|
Sound levels (decibel).
This will be measured with a validated application on a mobile phone
|
up to six days
|
Hart rate
Tijdsspanne: up to six days
|
hart rate is measured with a heart rate monitor and reported every two hours as beats per minute (BPM)
|
up to six days
|
Respiratory rate
Tijdsspanne: up to six days
|
Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute
|
up to six days
|
oxygen saturation
Tijdsspanne: up to six days
|
Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage
|
up to six days
|
Blood pressure
Tijdsspanne: 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)
|
up to six days
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Bram Tilburgs, Dr., adboudumc, intensive care, research
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2021-13078
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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