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The Effect of Eye Masks and Earplugs In Intensive Care Unit Patients

The Effect of Eye Masks and Earplugs on Sleep Quality and Life Findings In Intensive Care Unit Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05970614
Enrollment
60
Registered
2023-08-01
Start date
2023-09-01
Completion date
2024-01-16
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Quality, Vital Signs

Keywords

sleep quality, vital signs, intensive care, ear plugs, eye masks

Brief summary

This study was planned as a randomized controlled and experimental study to evaluate the effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.

Detailed description

The research will be conducted with 60 patients hospitalized in the intensive care units of a state hospital. Research data will be collected with a questionnaire, vital signs follow-up form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be divided into intervention and control groups. Eye mask and ear plugs will be applied to the intervention group for 3 days, and the control group will receive routine care. The study will be terminated after 3 days of follow-up for each patient.

Interventions

Eye masks and ear plugs will be applied to patients for 3 days between 22:00 and 06:00.

Sponsors

Osmaniye Korkut Ata University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Only participants were blinded in the study.

Intervention model description

randomized controlled trial with control and intervention groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years and over, * Able to answer all questions and communicate, * Those who agreed to participate in the research * Being in the category of insomnia, moderate insomnia, or severe insomnia according to the insomnia severity index, * Not sedating * Not connected to a ventilator * No hearing problem * Glasgow Coma Score of 15

Exclusion criteria

* Connecting to the ventilator during operation * Sedation during the study * Wanting to leave the research during the study * Being in the intervention group and removing the eye patch or earplug during sleep * GCS falling below 15

Design outcomes

Primary

MeasureTime frameDescription
Personal questionnaireOnly one times. At the first meeting (up to one day).It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.
Vital signs follow-up formup to 3 daysIt will be used to measure patients' fever, pulse, respiration, blood pressure and sPO2 values. It will be applied to patients at 22, 02, 06 hours. Also, the daily average hour will be calculated at the end of each day.
Insomnia Severity Indexup to 3 daysIt will be used to measure the severity of insomnia in patients. It consists of 7 questions and each question can receive points between 0 and 4. A maximum score of 28 and a minimum score of 0 are obtained on the scale, and as the score increases, the severity of insomnia increases.
Richards-Campbell Sleep Scaleup to 3 daysThe scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026