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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night. |
|
| Orientation about space and time | Active Comparator | This group will receive orientations about space and time olny, every night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eyemask and earplugs | Device | Eyemask and earplugs for use during the night, to improve sleep. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incident cases of delirium. | The short version of the Confusion Assessment Method (Short-CAM) will be used. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | A questionnaire composed of questions will be used. | Daily as long the patient is still being followed, up to 15 days from the inclusion in the study. |
| Safety of the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Artur S Schuh, PhD | Contact | 55 51 3359-8520 | schuh.afs@gmail.com | |
| Andressa H Hermes-Pereira, Master | Contact | 55 51 3359-8520 | andressahpereira@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Artur S Schuh, PhD | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | 90035903 | Brazil |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004430 | Ear Protective Devices |
| D013995 | Time |
| ID | Term |
|---|---|
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D011481 | Protective Clothing |
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| Orientation about space and time | Other | Information and orientation about space and time, given every night. |
|
Record of adverse effects.
| Daily as long the patient is still being followed, up to 15 days from the inclusion in the study. |
| Acceptance, confort and adherence to the intervention. | A four questions questionnaire will be used. | After every night of eyemask and earplugs use, up to 15 days from the inclusion in the study. |
| Use of psychotropic drugs. | Record of psychotropic drugs prescribed. | 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. |
| Time of hospital stay. | The total time of hospital stay will be recorded. | Until hospital discharge, up to 6 months from inclusion in the study. |
| Evaluation of the sleep-wake cycle. | Actigraphy: A technique for assessing the sleep-wake cycle that allows the recording of motor activity through limb movements for 24 hours or more. | Daily as long the patient is still being followed, up to 15 days from the inclusion in the study. |
| Urinary 6-sulfatoxymelatonin levels. | Urinary 6-sulfatoxymelatonin levels 48 hours after admission (first urine of the day). | 48 hours after admission (first urine of the day) |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003020 | Clothing |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D055585 | Physical Phenomena |