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

NCT05970614 | Completed

• 1 other identifier: OKU-SHMYO-OC-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality; Vital Signs

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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).

• 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

• 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

• 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

Study Arms (2)

Control group

NO INTERVENTION

No application will be made to the participants. Participants will receive routine care.

intervention group

OTHER

In addition to routine care, participants will be given eye masks and ear plugs for 3 days.

Other: Eye masks and ear plugs

Interventions

Eye masks and ear plugs OTHER

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

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osmaniye Korkut Ata University: lead

Study Sites (1)

Osmaniye Public Hospital

Osmaniye, Merkez, 80000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants were blinded in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: randomized controlled trial with control and intervention groups

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: September 1, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 16, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

TU (1)