Using Eye Mask and Earplugs on Prevention of Delirium

NCT05000476 | Unknown DMC

• 1 other identifier: GulsenK
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research is planned as a randomized controlled experimental study to examine the effect of using eye mask and earplugs in preventing delirium with evidence-based nonpharmacological nursing interventions in intensive care units.

Conditions

Delirium

Keywords

Delirium; Intensive care unit; Earplugs; Eyemask; Nursing

Outcome Measures

Primary Outcomes (1)

• delirium

  The effect of non-pharmacological interventions on the prevalence of delirium

  three days

Study Arms (3)

Nurse Education and Environmental Regulation

OTHER

Clinical nurses will be given training on delirium risks, diagnosis, prevention and management. In order to implement the interventions, environmental arrangements will be made in the intensive care units in the light of the training given, and the nurses will record which attempts are made during the day with the daily follow-up form.

Other: Nurse Education and Environmental Regulation

Eye mask and earplugs

EXPERIMENTAL

Patients will be monitored for 3 days starting from their hospitalization. Along with the regulations, each patient will be assisted by the intensive care nurses for 3 days between 23:00 p.m. - 06:00 a.m. for the use of eye mask and earplugs.

Other: eye mask and earplugs

Control

NO INTERVENTION

With the adjustments made, theywill receive the usual care for 3 days.

Interventions

eye mask and earplugs OTHER

Materials similar to those offered on long commercial flights

Eye mask and earplugs

Nurse Education and Environmental Regulation OTHER

providing orientation to the patient (frequent orientation of the patient to the place, time and person), cognitive stimulation (objects such as clocks and calendars in the patient's field of view), reducing noise and light (minimizing monitors and fluid infusion pump alarms at night), providing early mobilization ( passive-active joint movements, sitting and walking in bed), reducing social deprivation (receiving visitors, telephone calls)

Nurse Education and Environmental Regulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• The expected duration of stay in the intensive care unit is more than 24 hours.
• In the first 24 hours of hospitalization,
• On mechanical ventilation, conscious patients
• Patients who volunteered to participate in the study
• Not using sleeping pills\* \* Prescription drugs (benzodiazepines, nonbenzodiazepines), quetiapine, antihistamines, antidepressants used for their sedative effects

You may not qualify if:

• illness
• Suspected or approved drug or alcohol poisoning
• Contraindication to the use of earplugs or eye masks (eg facial trauma or other safety concerns)
• Patients using hearing aids
• Severe neurological deficits defined as coma (Richmond Agitation Sedation Score \<-4 or -5 (deeply sedated and coma) due to cranial trauma, malignancy, anoxic brain injury, or cerebral edema)
• Having a known cognitive disorder (such as dementia, Alzheimer's, psychosis.)
• Patients with a Glasgow coma scale (GCS) of 8 and below

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Delirium

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 11, 2021
• Study Start: February 21, 2020
• Primary Completion: May 10, 2021
• Study Completion: September 21, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

TU (1)