Clinical trial NCT05000476: Using Eye Mask and Earplugs on Prevention of Delirium
Official title: Effect of Eye Mask and Earplugs on Prevention of Delirium in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Keywords: Delirium
Intensive care unit
Earplugs
Eyemask
Nursing
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: delirium
timeFrame: three days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References: