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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorNecmettin Erbakan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• 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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eye mask

    Other intervention

    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.

  • Earplugs

    Other intervention

    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.

  • Eye Mask and Earplugs

    Other intervention

    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.

Treatment groups

128 Participants
are divided into 4 treatment groups
Group A: Eye Mask and EarplugsExperimental treatment 0 interventions
Group B: EarplugsExperimental treatment 0 interventions
Group C: Eye MaskExperimental treatment 1 intervention
Group D: no mask no earblugsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Richards-Campbell Sleep Scale

The RCUS was developed by Richards and colleagues (1987) to assess sleep. The RCUS includes six items (sleep depth, time to fall asleep, frequency of awakenings, time to remain awake when awakened, quality of sleep, and ambient noise level). Each item is rated using a 0-100 visual analog scale. The total score is obtained by dividing the individual items by their numbers: 0 represents the worst sleep, 100 the best sleep. As the score obtained from the scale increases, the sleep quality of the patients also increases. The RCUS provides a short, applicable, comprehensive, and simple tool for assessing sleep quality in the intensive care unit and is the most common. The Cronbach α value of the scale was found to be 0.82. The validity and reliability study of the scale in our country was conducted by Karaman Özlü and Özer (2015). The Cronbach Alpha internal consistency coefficient of the scale was found to be 0.91.

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

Nursing Delirium Screening Scale- Nu-DESC

The scale consists of five items. These are; disorientation, inappropriate behavior, inappropriate communication, illusion-hallucination and slowness in psychomotor behavior. It is critical that all subtypes can be detected in an effective delirium diagnosis. Among the items in Nu-DESC, it is thought that hypoactive delirium is detected more successfully with the item that evaluates psychomotor slowness. Each item in the scale takes a value between 0 and 2 points and the total score varies between 0 and 10. Two points and above indicate delirium. The evaluation time is approximately one minute.

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

Secondary outcomes

Other outcomes

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