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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05000476
Other study ID # GulsenK
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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