Delirium
Conditions
Keywords
Eyemask, Earplugs
Brief summary
This study evaluates the effect of earplugs and eyemask for delirium prevention among elderly in-patients. Half of patients will receive earplugs and eyemask for use during the night and information about orientation to time and space every night, while the other half will receive only the time and space orientations.
Detailed description
Delirium is an acute neuropsychiatric syndrome usually associated with a general medical condition. Its prevalence is high among hospitalized elderly patients and is generally underdiagnosed. Delirium is associated with prolonged hospitalization, increased mortality, institutionalization, falls, cognitive and functional decline and also with higher economic costs. The etiology of delirium is multifactorial, including excessive sensorial stimulation and disruption of the sleep-wake cycle as triggering factors. The aim of this study is evaluate the effect of earplugs and eyemask for delirium prevention among elderly in-patients of a brazilian university hospital. This will be a partially blinded clinical trial, in wich both control and intervention group will receive information about orientation to time and space every evening, and intervention group will also receive earplugs and eyemask for use during the night. The primary outcome will be the occurrence of delirium.
Interventions
DEVICEEyemask and earplugs
Eyemask and earplugs for use during the night, to improve sleep.
OTHEROrientation about space and time
Information and orientation about space and time, given every night.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* In-patients, expected to stay for at least 24 hours. * Understand and consent in participating in the study and sign the consent form. * 60 years of age, or older. * Visual and auditory acuity sufficient to perform cognitive tests.
Exclusion criteria
* Diagnosis of delirium in the selection visit. * Glasgow Coma Scale less than 15 in the selection visit. * PRISMA-7 ≤3 patient will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident cases of delirium. | Patients will be followed until diagnosis of delirium, death, discharge from hospital or transfer to another unit, up to 15 days from the inclusion in the study. | The short version of the Confusion Assessment Method (Short-CAM) will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | Daily as long the patient is still being followed, up to 15 days from the inclusion in the study. | A questionnaire composed of questions will be used. |
| Safety of the intervention. | Daily as long the patient is still being followed, up to 15 days from the inclusion in the study. | Record of adverse effects. |
| Acceptance, confort and adherence to the intervention. | After every night of eyemask and earplugs use, up to 15 days from the inclusion in the study. | A four questions questionnaire will be used. |
| Evaluation of the sleep-wake cycle. | Daily as long the patient is still being followed, up to 15 days from the inclusion in the study. | Actigraphy: A technique for assessing the sleep-wake cycle that allows the recording of motor activity through limb movements for 24 hours or more. |
| Time of hospital stay. | Until hospital discharge, up to 6 months from inclusion in the study. | The total time of hospital stay will be recorded. |
| Urinary 6-sulfatoxymelatonin levels. | 48 hours after admission (first urine of the day) | Urinary 6-sulfatoxymelatonin levels 48 hours after admission (first urine of the day). |
| Use of psychotropic drugs. | Patients will be followed until diagnosis of delirium, death, discharge from hospital or transfer to another unit, up to 15 days from the inclusion in the study. | Record of psychotropic drugs prescribed. |
Countries
Brazil
Contacts
Primary ContactArtur S Schuh, PhD
Backup ContactAndressa H Hermes-Pereira, Master
Outcome results
None listed