- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05078645
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.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Bram Tilburgs, Dr.
- Telefonnummer: 0031 24 36155618
- E-post: bram.tilburgs@radboudumc.nl
Studer Kontakt Backup
- Navn: Mark van den Boogaard, Dr.
- Telefonnummer: 0031 24 36155618
- E-post: mark.vandenboogaard@radboudumc.nl
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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
|
Annen: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Quality of sleep
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
NRS sleep
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: up to six days
|
Light level (LUX).
This will be measured with a validated application on a mobile phone
|
up to six days
|
Sound
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Bram Tilburgs, Dr., adboudumc, intensive care, research
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2021-13078
Plan for individuelle deltakerdata (IPD)
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