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

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Delirium

Treatments: Device: Eyemask and earplugs; Other: Orientation about space and time

Study type: Interventional

Funder types: Other

Identifiers

NCT03158909

160529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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284 participants in 2 patient groups

Interventional

Experimental group

Description:

Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night.

Treatment:

Other: Orientation about space and time

Device: Eyemask and earplugs

Orientation about space and time

Active Comparator group

Description:

This group will receive orientations about space and time olny, every night.

Treatment:

Other: Orientation about space and time