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NCT06010498Completed

The Effect of Eye Mask Applied on Patients Undergoing Coronary Artery Bypass Graft Surgery

The Effect of Eye Mask Applied on Patients Undergoing Coronary Artery Bypass Graft Surgery on Sleep Quality and Pain: Double-Blind Randomized Controlled Study

Source: ClinicalTrials.gov · Last updated 27 Mar 2024

Brief summary (registry, in English)

Introduction: Coronary Artery Bypass Graft (CABG) performed with open heart surgery technique is a successful operation in the treatment of cardiovascular diseases. Incision of the sternum region, saphenous vein graft, sternal retraction, presence of chest and mediastinal tubes cause pain. The pain experienced by the patients, the complications related to the disease they have, and the stress they experience cause an increase in sleep problems. In addition, the increase in sympathetic activity after surgery and nursing care interventions also affect sleep quality. The literature reports that sleep disorders affect the working physiology of the heart in patients with cardiac disease, adversely affect heart health and affect postoperative recovery. In addition, since sleep disorders are also associated with cardiovascular diseases, it is of great importance to improve the sleep quality of this group of patients. One of the non-pharmacological nursing interventions is the eye patch. The eye patch is an instrument made of fabric, with an elastic strap, aimed at pure darkness by diverting all light from the patient's eyes. The main physiological purpose of using an eye patch is to adjust the hormones melatonin and cortisol, which affect the circadian rhythm. As a result, it is thought that the eye patch will prevent patients from being exposed to excessive light in the hospital environment, the regulation of hormones and sleep quality will improve, and the pain will decrease. Purpose: The aim of this study is to examine the effect of eye patch applied to patients undergoing coronary artery bypass graft surgery on sleep quality and pain. Method: Individuals who have undergone coronary artery bypass graft surgery in accordance with the sampling inclusion criteria will be randomly assigned to the experimental and control groups by block randomization. After determining the groups, each patient in the experimental and control groups, whose written consent was obtained, will have the first researcher fill out the Descriptive Characteristics Form, Richards-Campbell Sleep Questionnaire and Numerical Pain Scale on the morning of the first night they spent in the clinic. Patients in the experimental group will be given the "standard care" and "eye patch" application in the clinic on their 2nd and 3rd nights in the clinic. The patients in the control group will only be provided with the "standard care" in the clinic on their 2nd and 3rd nights in the clinic. Patients in both groups will be asked to fill out the Richards-Campbell Sleep Questionnaire and Numerical Pain Scale forms in the mornings of the 2nd and 3rd nights.

Status (registry)
Completed
Study type
Interventional
Enrollment
64 (actual)
First submitted
11 Aug 2023
Start date
10 Jul 2023
Primary completion date
1 Jan 2024
Lead sponsor
Kutahya Health Sciences University
NCT number
NCT06010498

What you commit to

  • Study type: Interventional
  • Participants enrolled: 64
  • From 10 Jul 2023 to the primary completion date, 1 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • During CABG surgery, mitral valve repair or replacement (Each type of heart surgery will differ in terms of operation time, site of surgery, recovery time, and length of hospital stay, which may affect the patient's anxiety.)

Lab values

  • Low risk factor for complications (eg ejection fraction \< 35%).

Other

  • Patients with chest tube and drain
  • Patients with vision problems
  • Patients with hearing problems
  • Patients with claustrophobia

Who the study is looking for

  • Over 18 years old
  • Those under 65 (Studies show that nighttime awakenings and sleep durations change with age (Lie et al., 2018)
  • Can speak Turkish
  • Those who agreed to participate in the study
  • Those who have not had open heart surgery before
  • No emergency bypass surgery
  • No intra-aortic balloon pump or pacemaker
  • Not taking inotropic drugs
  • Those who have not consumed coffee or hypnotic drugs at least 12 hours before
  • Those who have not been working the night shift for the last 3 months
  • No history of chronic pain (eg arthritis)
  • Able to wear an eye mask on their own
  • Not addicted to alcohol and drugs
  • Does not have a psychological problem (such as depression, anxiety disorder)
  • No anxiolytic use
  • No chronic sleep problems
  • Not using sleeping pills

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Necibe
Coordinator of this site? Confirm its status
KütahyaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.