search
Back to results

Using Eye Mask and Earplugs on Prevention of Delirium

Primary Purpose

Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
eye mask and earplugs
Nurse Education and Environmental Regulation
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Delirium, Intensive care unit, Earplugs, Eyemask, Nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

No Intervention

Arm Label

Nurse Education and Environmental Regulation

Eye mask and earplugs

Control

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

delirium
The effect of non-pharmacological interventions on the prevalence of delirium

Secondary Outcome Measures

Full Information

First Posted
August 4, 2021
Last Updated
August 12, 2021
Sponsor
Baskent University
search

1. Study Identification

Unique Protocol Identification Number
NCT05000476
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2020 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
September 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Intensive care unit, Earplugs, Eyemask, Nursing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse Education and Environmental Regulation
Arm Type
Other
Arm Description
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.
Arm Title
Eye mask and earplugs
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
With the adjustments made, theywill receive the usual care for 3 days.
Intervention Type
Other
Intervention Name(s)
eye mask and earplugs
Intervention Description
Materials similar to those offered on long commercial flights
Intervention Type
Other
Intervention Name(s)
Nurse Education and Environmental Regulation
Intervention Description
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)
Primary Outcome Measure Information:
Title
delirium
Description
The effect of non-pharmacological interventions on the prevalence of delirium
Time Frame
three days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Baskent University
City
Ankara
ZIP/Postal Code
06790
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Using Eye Mask and Earplugs on Prevention of Delirium

We'll reach out to this number within 24 hrs