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Not yet recruiting NCT06752980

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

No phase Interventional Cardiovascular Surgical Procedures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eye mask, Earplugs, Eye Mask and Earplugs.
Who it may be relevant to
Registry conditions: Cardiovascular Surgical Procedures. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other 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.
  • 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.
  • 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.

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Health services research

Study locations

Turkey (Türkiye) · 1 center
  • Necmettin Erbakan Universıty — Selçuklu

Publications

  • 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. PMID 37138379

Identifiers

NCT: NCT06752980 · NecmettinEU-SBF-ZB-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗