Trial of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial to Evaluate the Effect of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients

Conditions
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Delirium

Intervention / Treatment
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* Device: Eyemask and earplugs
* Other: Orientation about space and time


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night. | Device: Eyemask and earplugs<br>* Eyemask and earplugs for use during the night, to improve sleep.<br>Other: Orientation about space and time<br>* Information and orientation about space and time, given every night.<br>|
| Active Comparator: Orientation about space and time<br>This group will receive orientations about space and time olny, every night. | Other: Orientation about space and time<br>* Information and orientation about space and time, given every night.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eyemask, Earplugs