Clinical trial NCT06010498: The Effect of Eye Mask Applied on Patients Undergoing Coronary Artery Bypass Graft Surgery
Official title: The Effect of Eye Mask Applied on Patients Undergoing Coronary Artery Bypass Graft Surgery on Sleep Quality and Pain: Double-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Sleep Disorder
Pain, Postoperative
Keywords: Heart Surgery
pain
CABG
eye mask
nursing
sleep quality
randomized controlled trial
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Cardiovascular diseases (CVDs) are among the leading causes of death globally. Coronary Erter Bypass Graft (CABG) performed with open heart surgery technique is a successful operation in the treatment of cardiovascular diseases. In the face of this life-threatening experience, patients face many stressors until discharge, and pain is one of them and causes anxiety. Incision of the sternum region, saphenous vein graft, sternal retraction, presence of chest and mediastinal tubes cause pain. Mild to moderate pain persisting until the post-operative 7th day indicates that pain persists as an important postoperative problem in this patient group. 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 and nursing care interventions after surgery also affect sleep quality.Nurses are responsible for meeting the basic life needs of the patients they care for. The most important of these needs is sleep. Sleep deprivation causes cognitive problems in patients, affects the immune system, and causes nosocomial infections, affecting recovery time. 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, deterioration of sleep quality causes more pain and increased pain intensity, delaying wound healing. In addition, since sleep disorders are also associated with cardiovascular diseases, it is of great importance to increase the sleep quality of this group of patients. There are many factors that affect the sleep quality of patients. The most important factor that impairs sleep quality is light. Inexpensive and non-pharmaceutical methods can be preferred to improve the sleep quality of patients. Environmental regulations can improve sleep quality. Therefore, it is reported that environmental changes such as dim and dark clinics increase sleep quality. Apart from these, one of the non-pharmacological nursing interventions is the eye patch. The eye patch is an instrument made of fabric, with an elastic strap, aiming 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. There are many studies in the literature on the sleep quality of patients using eye patches, and the results show that the eye patch improves sleep quality. However, from a limited number of studies examining the effects of eye patch on sleep and pain in patients who have undergone cardiac surgery. Due to the limited number of studies, it was aimed to examine the effect of eye patch applied to patients undergoing coronary artery bypass graft surgery on sleep quality and pain.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Low risk factor for complications (eg ejection fraction \< 35%).
* 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.)
* Patients with chest tube and drain
* Patients with vision problems
* Patients with hearing problems
* Patients with claustrophobia

Primary outcomes:
measure: sleep quality measurement (Richards- Campbell Sleep Questionnaire)
timeFrame: Once a day on the second day in the morning, on the third day in the morning, on the fourth day in the morning
measure: pain measurement (numerical pain scale)
timeFrame: Once a day on the second day in the morning, on the third day in the morning, on the fourth day in the morning
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Necibe
Study officials:
affiliation: kütahya health sciences university
name: Burcu NAL, Msc RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Gülşah GÜROL ARSLAN, Msc RN
role: PRINCIPAL_INVESTIGATOR
affiliation: kütahya health sciences university
name: Mehmet Ali ASTARCIOĞLU, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: kütahya health sciences university
name: Ali İhsan PARLAR, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Necibe DAĞCAN, Msc RN
role: PRINCIPAL_INVESTIGATOR
References: