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

Sponsor

Osmaniye Korkut Ata University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05970614

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Quality Vital Signs	Other: Eye masks and ear plugs	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized controlled trial with control and intervention groupsrandomized controlled trial with control and intervention groups

Masking:

Single (Participant)

Masking Description:

Only participants were blinded in the study.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Jan 15, 2024

Anticipated Study Completion Date :

Aug 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group No application will be made to the participants. Participants will receive routine care.
Other: intervention group In addition to routine care, participants will be given eye masks and ear plugs for 3 days.	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.

Arm

Intervention/Treatment

No Intervention: Control group

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

Other: intervention group

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

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.

Outcome Measures

Primary Outcome Measures

Personal questionnaire [Only 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 form [up to 3 days]
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.
Insomnia Severity Index [up to 3 days]
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.
Richards-Campbell Sleep Scale [up to 3 days]
The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Osmaniye Korkut Ata University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

onur çetinkaya, PhD, Lecturer, Osmaniye Korkut Ata University

ClinicalTrials.gov Identifier:

NCT05970614

Other Study ID Numbers:

OKU-SHMYO-OC-01

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by onur çetinkaya, PhD, Lecturer, Osmaniye Korkut Ata University

Study Results

No Results Posted as of Aug 1, 2023