The Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs

NCT ID: NCT05451186

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2022-11-15

Brief Summary

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This study was planned to investigate the effects of eye patch and headphones on sleep quality, anxiety, fear and vital signs in coronary intensive care unit patients.

Detailed Description

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In intensive care units, it can be much easier to change the environment perception of patients with simple tools such as headphones and sleep bands, rather than changing the environment of the patients. The use of sleep bands and headphones, which are non-pharmacological methods, can reduce sleep deprivation by changing the environmental perception of the patients.

Conditions

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Intensive Care Unit Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This research is a single-blind study with a pretest-posttest randomized control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Experimental group and control group

Study Groups

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Eye patch and headphones

Eye patch and headphones

Group Type EXPERIMENTAL

Eye patch and headphones

Intervention Type OTHER

Patients in the experimental group will be asked to use an eye mask and earplugs from 22:30 to 6:30 in the morning on the 1st, 2nd and 3rd nights.

Control group

Routine maintenance will be applied

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eye patch and headphones

Patients in the experimental group will be asked to use an eye mask and earplugs from 22:30 to 6:30 in the morning on the 1st, 2nd and 3rd nights.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being 18 years or older,
* New York Heart Association (NYHA) functional class II and III,
* Not having received any general anaesthesia for the previous 24 hours,
* Not having received any sedative medications or opioids for the past 24 hours,
* Not having a verbal communication disability (hearing and speaking),
* Absence of pain,
* Not having a previously diagnosed sleep disorder,
* Not having psychiatric problems,
* Not having a cognitive problem,
* Being healthy enough to put on and take off earplugs independently, in addition to wearing an eye mask and removing it when necessary, and continuing to be hospitalized for at least three days.

Exclusion Criteria

* Diagnosed with delirium (Intensive care delirium screening checklist \>=5),
* Unconscious (Glasgow coma scale\<13),
* Presence of additional chronic diseases,
* Having consumed coffee, alcohol and hypnotic drugs at least 12 hours before the study,
* Patients whose condition suddenly worsened,
* Those who cannot use earplugs and eye masks effectively at night,
* Those who voluntarily withdrew from the study and were transferred from the intensive care unit.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Sabahattin Zaim University

OTHER

Sponsor Role lead

Responsible Party

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Zülfünaz ÖZER

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zülfünaz Özer

Role: STUDY_DIRECTOR

Istanbul Sabahattin Zaim University

Locations

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Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kasapoglu ES, Enc N. Role of multicomponent non-pharmacological nursing interventions on delirium prevention: A randomized controlled study. Geriatr Nurs. 2022 Mar-Apr;44:207-214. doi: 10.1016/j.gerinurse.2022.02.015. Epub 2022 Feb 26.

Reference Type RESULT
PMID: 35227973 (View on PubMed)

Other Identifiers

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8991

Identifier Type: -

Identifier Source: org_study_id

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