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

NCT06010498 | Completed DMC

• 1 other identifier: KutahyaHSU-NECIBE-DAGCAN-0002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Sleep Disorder; Pain, Postoperative

Keywords

Heart Surgery; pain; CABG; eye mask; nursing; sleep quality; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• sleep quality measurement (Richards- Campbell Sleep Questionnaire)

  Richards- Campbell Sleep Questionnaire: Developed by Richards in 1987, the Richard-Campbell Sleep Questionnaire (RCSQ) is a 6-item scale that evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart between 0 and 100 with the visual analog scale technique. A score of "0-25" from the scale indicates very bad sleep, and a score of "76-100" indicates very good sleep. As the score of the scale increases, the sleep quality of the patients also increases. The Cronbach α value of the scale developed by Richards was found to be 0.82. The Turkish validity and reliability of the scale was investigated by Özlü and Özer in 2015 and the Cronbach α value was found to be 0.91.

  Once a day on the second day in the morning, on the third day in the morning, on the fourth day in the morning

• pain measurement (numerical pain scale)

  Numerical Pain Scale:It is based on the expression of pain intensity in numbers. While the absence of pain is expressed as 0 in numerical scales, the number shown increases as the severity of pain increases, and 10 points represent unbearable pain. Numerical scales have been adopted more because they facilitate the definition of pain severity and facilitate scoring and recording.

  Once a day on the second day in the morning, on the third day in the morning, on the fourth day in the morning

Study Arms (2)

Eye Mask Group

EXPERIMENTAL

Behavioral: eye mask; Behavioral: standart care

Standart Care

NO INTERVENTION

Interventions

eye mask BEHAVIORAL

* First day morning The Introductory Characteristics Form will be filled. * First day night Standard care will be given * Second day morning Richards-Campbell Sleep Questionnaire and Numerical Pain Scale to be filled * Second day night Standard care will be given + eye patch will be applied (22:00-06:00) * Third day morning Richards-Campbell Sleep Questionnaire and Numerical Pain Scale to be filled * Third day night Standard care will be given + eye patch will be applied (22:00-06:00) * Fourth day morning Richards-Campbell Sleep Questionnaire and Numerical Pain Scale to be filled

Eye Mask Group

standart care BEHAVIORAL

Control group (n) * First day morning The Introductory Characteristics Form will be filled. * First day night Standard care will be given * Second day morning Richards-Campbell Sleep Questionnaire and Numerical Pain Scale to be filled * Second day night Standard care will be given * Third day morning Richards-Campbell Sleep Questionnaire and Numerical Pain Scale to be filled * Third day night Standard care will be given) * Fourth day morning Richards-Campbell Sleep Questionnaire and Numerical Pain Scale to be filled

Eye Mask Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Necibe

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease; Sleep Wake Disorders; Pain, Postoperative; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Postoperative Complications; Pathologic Processes; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Burcu NAL, Msc RN

  kütahya health sciences university

  PRINCIPAL INVESTIGATOR

• Gülşah GÜROL ARSLAN, Msc RN

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Mehmet Ali ASTARCIOĞLU, Doctor

  kütahya health sciences university

  PRINCIPAL INVESTIGATOR

• Ali İhsan PARLAR, Doctor

  kütahya health sciences university

  PRINCIPAL INVESTIGATOR

• Necibe DAĞCAN, Msc RN

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 24, 2023
• Study Start: July 10, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

TU (1)