Using Eye Mask and Earplugs on Prevention of Delirium

Effect of Eye Mask and Earplugs on Prevention of Delirium in Intensive Care Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Delirium
• Intervention / Treatment: Other: Nurse Education and Environmental Regulation; Other: eye mask and earplugs

Detailed Description

In the prevention of delirium, the necessity of using a multicomponent, nonpharmacological interventions is emphasized and focused on nursing interventions. In this regard, it is believed that the use of eye mask and ear plugs, which have recently started to take place in the guides, as well as known evidence-based nursing interventions, will provide nurses with power to improve delirium-related outcomes.

The research is expected to consist of intervention and control groups older than 18, volunteering to participate in the research, which the expected length of stay in the ICU more than 24 hours at Başkent University Ankara Hospital. Data will be collected through Patient Information Form, APACHE II, Glasgow Coma Scale, Richmond Sedation Agitation Scale, Nursing-Delirium Screening Scale, Richard-Campbell Sleep Scale and Daily Monitoring Form. In preparation step of the research, nurses will be trained, guidelines are required for nurses, necessary interventions will be planned. At the application stage , after determining the experimental and control groups, eye mask and ear plugs will be given before going to sleep in addition to the patients in the experimental group, before going to sleep, and followed for three days. Also, it will be examined through a semi-structured interview technique for the examination of patients in the experimental group.It is believed that the early diagnosis of delirium, nonpharmacological interventions to be implemented will affect the diagnosis-treatment costs positively by reducing morbidity and mortality rates.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06790
    • Baskent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nurse Education and Environmental Regulation; 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; 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)
Experimental: Eye mask and earplugs; 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; Materials similar to those offered on long commercial flights
No Intervention: Control; With the adjustments made, theywill receive the usual care for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delirium	The effect of non-pharmacological interventions on the prevalence of delirium	three days

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Actual): May 10, 2021
• Study Completion (Anticipated): September 21, 2021

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Intensive care unit; Nursing; Delirium; Eyemask; Earplugs
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: GulsenK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No