DeliriumNCT05000476
Using Eye Mask and Earplugs on Prevention of Delirium
A study testing eye mask and earplugs and Nurse Education and Environmental Regulation in people with Delirium, run by Baskent University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- eye mask and earplugs and Nurse Education and Environmental Regulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2020to 21 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Eye Mask and Earplugs on Prevention of Delirium in Intensive Care Patients
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.
Read the 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
- Being tested
- eye mask and earplugs, Nurse Education and Environmental Regulation
- Keywords
- Delirium, Intensive care unit, Earplugs, Eyemask, Nursing
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye mask and earplugsOther
Materials similar to those offered on long commercial flights
Nurse Education and Environmental RegulationOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Nurse Education and Environmental Regulation | Other | 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. Receives: Other: Nurse Education and Environmental Regulation |
| Eye mask and earplugs | Experimental | 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. Receives: Other: eye mask and earplugs |
| Control | No intervention | With the adjustments made, theywill receive the usual care for 3 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
delirium
The effect of non-pharmacological interventions on the prevalence of delirium
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start21 Feb 2020
- Primary completion10 May 2021
- Study completion21 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşen Kılıç, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000476
- Sponsor's protocol ID
- GulsenK
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eye Mask and Earplugs on Prevention of Delirium in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05000476
- Acronym / sponsor ID
- GulsenK
- Conditions
- Delirium
- Keywords
- Delirium, Intensive care unit, Earplugs, Eyemask, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 21 Sep 2021 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nurse Education and Environmental Regulation | Other | Other: Nurse Education and Environmental RegulationClinical 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. |
| Eye mask and earplugs | Experimental | Other: eye mask and earplugsPatients 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. |
| Control | No intervention | –With the adjustments made, theywill receive the usual care for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eye mask and earplugsMaterials similar to those offered on long commercial flights | Other | Eye mask and earplugs |
| Nurse Education and Environmental Regulationproviding 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) | Other | Nurse Education and Environmental Regulation |
Primary outcome
delirium
Time frame: three days
The effect of non-pharmacological interventions on the prevalence of delirium
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye mask and earplugs and Nurse Education and Environmental Regulation in people with Delirium, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delirium (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.