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Using Eye Mask and Earplugs on Prevention of Delirium

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05000476
Enrollment
60
Registered
2021-08-11
Start date
2020-02-21
Completion date
2021-09-21
Last updated
2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Delirium, Intensive care unit, Earplugs, Eyemask, Nursing

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.

Interventions

Materials similar to those offered on long commercial flights

OTHERNurse 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)

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
deliriumthree daysThe effect of non-pharmacological interventions on the prevalence of delirium

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026