Coronary Artery DiseaseNCT06010498
The Effect of Eye Mask Applied on Patients Undergoing Coronary Artery Bypass Graft Surgery
A study testing eye mask and standart care in people with Coronary Artery Disease and Sleep Disorder, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Sleep Disorder, Pain, Postoperative
- What is being tested?
- eye mask and standart care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Sleep Disorder, Pain, Postoperative
- Being tested
- eye mask, standart care
- Keywords
- Heart Surgery, pain, CABG, eye mask, nursing, sleep quality, randomized controlled trial
- Medical subject headings
- Coronary Artery Disease, Sleep Wake Disorders, Pain, Postoperative, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye maskBehavioural
- 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
standart careBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Eye Mask Group | Experimental | Not described Receives: Behavioral: eye mask; Behavioral: standart care |
| Standart Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Once a day on the second day in the morning, on the third day in the morning, on the fourth day in the morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start10 Jul 2023
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necibe Dağcan, Kutahya Health Sciences University
- Investigators
- Burcu NAL, Msc RN, Principal investigator, kütahya health sciences universityGülşah GÜROL ARSLAN, Msc RN, Principal investigator, Dokuz Eylul UniversityMehmet Ali ASTARCIOĞLU, Doctor, Principal investigator, kütahya health sciences universityAli İhsan PARLAR, Doctor, Principal investigator, kütahya health sciences universityNecibe DAĞCAN, Msc RN, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010498
- Sponsor's protocol ID
- KutahyaHSU-NECIBE-DAGCAN-0002
- Status last verified
- Mar 2024
- First submitted
- 11 Aug 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06010498
- Acronym / sponsor ID
- KutahyaHSU-NECIBE-DAGCAN-0002
- Conditions
- Coronary Artery Disease, Sleep Disorder, Pain, Postoperative
- Keywords
- Heart Surgery, pain, CABG, eye mask, nursing, sleep quality, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye Mask Group | Experimental | Behavioral: eye mask, Behavioral: standart care |
| Standart Care | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eye mask* 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 | Behavioural | Eye Mask Group |
| standart careControl 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 | Behavioural | Eye Mask Group |
Primary outcome
sleep quality measurement (Richards- Campbell Sleep Questionnaire)
Time frame: Once a day on the second day in the morning, on the third day in the morning, on the fourth day in the morning
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.
pain measurement (numerical pain scale)
Time frame: Once a day on the second day in the morning, on the third day in the morning, on the fourth day in the morning
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu NAL, Msc RN principal investigator
kütahya health sciences university
Gülşah GÜROL ARSLAN, Msc RN principal investigator
Dokuz Eylul University
Mehmet Ali ASTARCIOĞLU, Doctor principal investigator
kütahya health sciences university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye mask and standart care in people with Coronary Artery Disease and Sleep Disorder, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality measurement (Richards- Campbell Sleep Questionnaire) (time frame: Once a day on the second day in the morning, on the third day in the morning, on the fourth day in the morning). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.