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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05970614
Other study ID # OKU-SHMYO-OC-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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