The Effect of Eye Mask and Earplugs on Sleep Quality and Delirium in Coronary Artery Bypass Graft Patients: A Randomized Controlled Study

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-05-01

Brief Summary

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Coronary artery bypass grafting is the most commonly performed surgical procedure among cardiovascular diseases. Nursing care for patients undergoing cardiac surgery involves a process that includes preoperative preparation and subsequent close monitoring of neurological, cardiac, respiratory, vascular status, kidney function, and pain. Sleep disturbances are observed after cardiac surgery. Sleep plays a critical role in the body's maintenance, repair, and renewal processes. Improved sleep can reduce patient agitation and decrease the risk of delirium. The presence of delirium leads to increased care requirements and prolonged hospital stays, which in turn raises hospital costs. Enhancing sleep quality and preventing delirium after surgery have positive effects on clinical patient outcomes. This study is designed to determine the effects of using eye masks and/or earplugs on sleep quality and delirium in patients undergoing coronary artery bypass grafting during nighttime sleep. This research is a randomized controlled clinical trial.

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Detailed Description

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Conditions

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Cardiovascular Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Eye Mask and Earplugs

On the 1st, 2nd and 3rd postoperative day, the experimental group will be given the intervention reserved during their night sleep, using eye patches and earplugs.

On the 2nd, 3rd and 4th postoperative day, repeated monitoring will be performed using RCUÖ and Nu-DESC.

Patients who wish to leave the study at any stage, do not receive the reserved intervention or die during the monitoring will be excluded from the study.

Group Type EXPERIMENTAL

No interventions assigned to this group

Earplugs

The reserved intervention will be applied during the night sleep with earplugs on the 1st, 2nd and 3rd day group after the surgery.

Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after the surgery.

Patients who want to leave at any stage of the study, do not receive the reserved intervention or die during the monitoring will be excluded from the study.

Group Type EXPERIMENTAL

No interventions assigned to this group

Eye Mask

The intervention allocated during night sleeps with Eye Mask applied on the 1st, 2nd and 3rd days after the surgery will be applied.

Repeated monitoring will be done using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after the surgery.

Patients who want to leave at any stage of the study, do not perform the allocated intervention or die during the follow-up will be excluded from the study.

Group Type EXPERIMENTAL

Eye mask

Intervention Type OTHER

The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.

no mask no earblugs

No intervention will be performed on the 1st, 2nd and 3rd postoperative day.

Repeated monitoring will be performed on the 2nd, 3rd and 4th postoperative day using RCUÖ and Nu-DESC.

Patients who wish to leave the study at any stage, who do not perform the intervention, or who die during follow-up will be excluded from the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eye mask

The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.

Intervention Type OTHER

Earplugs

The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.

Intervention Type OTHER

Eye Mask and Earplugs

The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

-Patients who voluntarily agree to participate in the study

* Those who have undergone coronary artery bypass graft surgery
* Those between the ages of 18-79
* Those who are cooperative and oriented
* Those who are literate
* Those who speak Turkish
* Those whose initial delirium scale score (Nu-DECS) is less than 2
* Those whose Glasgow coma scale score is \>13 will be included in the study.

Exclusion Criteria

* • Patients diagnosed with sleep disorders,

* Those using sleeping pills,
* Those who have a habit of using an eye patch while sleeping,
* Those who were not transferred to the clinic on the first day after surgery and whose treatment continues in the intensive care unit,
* Those who develop complications and/or need to be re-operated,
* Those who need treatment other than routine treatment,
* Patients with hearing or vision problems will be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No