Using Eye Mask and Earplugs on Prevention of Delirium

NCT ID: NCT05000476

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-21
• Study Completion Date: 2021-09-21

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Nurse Education and Environmental Regulation

Intervention Type: OTHER

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)

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.

Group Type: EXPERIMENTAL

eye mask and earplugs

Intervention Type: OTHER

Materials similar to those offered on long commercial flights

Control

With the adjustments made, theywill receive the usual care for 3 days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eye mask and earplugs

Materials similar to those offered on long commercial flights

Intervention Type: 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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Gülşen Kılıç

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baskent University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GulsenK

Identifier Type: -

Identifier Source: org_study_id