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

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Surgical Procedures

• Registration Number: NCT06752980
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-21
• Study First Submitted QC: 2024-12-21
• Last Update Submitted: 2024-12-21
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Study Start: 2025-01-01
• Primary Completion: 2025-11-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Richards-Campbell Sleep Scale	Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.	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.
Nursing Delirium Screening Scale- Nu-DESC	Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.	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.

Trial Locations

Locations (1)

Necmettin Erbakan Universıty; 🇹🇷 Selçuklu, Konya, Turkey