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

Sleep Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970614
• Other study ID #: OKU-SHMYO-OC-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: April 2024
• Source: Osmaniye Korkut Ata University
• Contact: Onur Çetinkaya, PhD
• Phone: +905434317049
• Email: dr.onurcetinkaya01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Quality
• Vital Signs

Intervention

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

Locations

Country	Name	City	State
Turkey	Osmaniye Public Hospital	Osmaniye	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Osmaniye Korkut Ata University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal questionnaire	It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.	Only one times. At the first meeting (up to one day).
Primary	Vital signs follow-up form	It 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.	up to 3 days
Primary	Insomnia Severity Index	It 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.	up to 3 days
Primary	Richards-Campbell Sleep Scale	The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.	up to 3 days