Using Eye Mask and Earplugs on Prevention of Delirium

Not Applicable

• Conditions: Delirium
• Interventions: Other: eye mask and earplugs; Other: Nurse Education and Environmental Regulation

• Registration Number: NCT05000476
• Lead Sponsor: Baskent University

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.

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 Timeline

• Study Start: 2020-02-21
• Primary Completion: 2021-05-10
• Status Verified: 2021-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-11
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-18
• Study Completion: 2021-09-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eye mask and earplugs	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.
Nurse Education and Environmental Regulation	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.

Primary Outcome Measures

Name	Time	Method
delirium	three days	The effect of non-pharmacological interventions on the prevalence of delirium

Trial Locations

Locations (1)

Baskent University; 🇹🇷 Ankara, Turkey