Clinical trial NCT06752980: The Effect of Eye Mask and Earplugs on Sleep Quality and Delirium in Coronary Artery Bypass Graft Patients: A Randomized Controlled Study
Official title: The Effect of Eye Mask and Earplugs on Sleep Quality and Delirium in Coronary Artery Bypass Graft Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Surgical Procedures
Keywords: Cardiovascular surgical procedures, Delirium, Sleep
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Richards-Campbell Sleep Scale
timeFrame: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.
measure: Nursing Delirium Screening Scale- Nu-DESC
timeFrame: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Necmettin Erbakan Universıty
state: Konya
Study officials:
affiliation: Necmeetin Erbakan University
name: Saide Faydalı
role: STUDY_DIRECTOR
References:
citation: Kilic G, Kav S. Effect of using eye masks and earplugs in preventing delirium in intensive care patients: A single-blinded, randomized, controlled trial. Nurs Crit Care. 2023 Sep;28(5):698-708. doi: 10.1111/nicc.12901. Epub 2023 May 3.