Using Eye Mask and Earplugs on Prevention of Delirium

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05000476
• Other study ID #: GulsenK
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 21, 2020
• Est. completion date: September 21, 2021

Study information

• Verified date: August 2021
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 21, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• eye mask and earplugs
Materials similar to those offered on long commercial flights
• 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)

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delirium	The effect of non-pharmacological interventions on the prevalence of delirium	three days