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

Necmettin Erbakan University

Status: Not yet enrolling

Conditions: Cardiovascular Surgical Procedures

Treatments: Other: Eye Mask and Earplugs; Other: Eye mask; Other: Earplugs

Study type: Interventional

Funder types: Other

Identifiers

NCT06752980

NecmettinEU-SBF-ZB-01

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 4 patient groups

Eye Mask and Earplugs

Experimental group

Description:

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.

Earplugs

Experimental group

Description:

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.

Eye Mask

Experimental group

Description:

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.

Treatment:

Other: Eye mask

no mask no earblugs

No Intervention group

Description:

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.