The effects of earplugs and eye masks during the night on the onset of delirium and sleep quality in patients undergoing coronary artery bypass grafting
Determining the effect of using earplugs and eye masks during the night on sleep quality and onset of delirium in patients with coronary artery bypass graft surgery.
Design
Single blind randomized controlled clinical trial with control group
will be selected by block random sampling method on 114 eligible patients with coronary artery bypass graft surgery and will be placed in two experimental and control groups. Then the random arrangement of the samples will be done using Random Allocation Software 2.0 in the form of 19 blocks of 6.
Settings and conduct
The intervention is performed simultaneously with the use of eye masks and earplugs in the intensive care unit for three consecutive nights from 21-22 to 6-7 in the morning for the experimental group. Turn the earplug into a thin spiral by twisting it, and then pull the sponge into the ear canal by pulling the top of the ear up and back and hold it for 20-30 minutes so that the sponge expands in the ear canal. The control group receives only routine ward care.
Participants/Inclusion and exclusion criteria
Patients aged ≥18 years
People who have undergone coronary artery bypass graft surgery
Orientation to person, time and place
absence of hearing, speech and vision impairment
No previous cognitive pathology (including dementia, stroke, traumatic brain injury, encephalopathy, drug and alcohol abuse)
no need for intubation more than 24 hours
Intervention groups
The intervention is performed simultaneously with the use ofearplugs and eye masks for three consecutive nights (from the second night of admission) from 21-22 to 6-7 in the morning by the care nurse for the experimental group. they receive.
Main outcome variables
Sleep quality and severity of delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210523051370N2
Registration date:2021-07-23, 1400/05/01
Registration timing:registered_while_recruiting
Last update:2021-07-23, 1400/05/01
Update count:0
Registration date
2021-07-23, 1400/05/01
Registrant information
Name
Seyed Afshin Shorofi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
ashorofi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-22, 1400/04/31
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of earplugs and eye masks during the night on the onset of delirium and sleep quality in patients undergoing coronary artery bypass grafting
Public title
The effect of using eye masks and earplugs on the onset of postoperative confusion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged ≥18 years
People who have undergone coronary artery bypass graft surgery
orientation to time, place and person
absence of hearing, speech and vision impairment
No previous cognitive pathology (including dementia, stroke, traumatic brain injury, encephalopathy, drug and alcohol abuse)
no need for intubation more than 24 hours
Exclusion criteria:
Delirium at the time of entry criteria based on the Neecham scale
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be recruited using convenience sampling method and then will be randomly assigned to the experimental (group A) and control (group B) groups using block method (19 blocks) of length 6. The blocks will be numbered and sealed in 19 sequentially numbered opaque envelopes in random order (by someone outside the research team and unaware of the research objectives).
The envelopes will be opened individually and the patients will be assigned to the relevant groups. The Random Allocation Software 2.0 will be used to generate randomization sequences.
Blinding (investigator's opinion)
Single blinded
Blinding description
the Assessor and Statistician will be blind to Randomization.
Placebo
Not used
Assignment
Parallel
Other design features
The experimental group will receive earplugs and eye masks And the control group receive only routine care. The intervention is performed simultaneously with the use of eye masks and earplugs in the cardiac intensive care unit for three consecutive nights (from the second night of admission) from 21-22 to 6-7 am by the caring nurse for the experimental group. Press and twist the earplugs into a spiral and thin, and then by pulling the top of the ear up and back, smooth the ear canal and press the sponge into the ear canal and hold 20-30 until the sponge expands in the ear canal. And after 10 minutes, check if the eye masks and earplugs are in place. If necessary, the patient's eye masks and earplug can be removed and reused to communicate with the patient and perform medical and nursing care. The earplugs is disposable, but the eye masks can be used for three nights of intervention.
Secondary Ids
1
Registry name
کمیته تخصصی اخلاق در پژوهش های زیست پزشکی
Secondary trial Id
IR.MAZUMS.REC.1400.303
Registration date
2021-07-07, 1400/04/16
Ethics committees
1
Ethics committee
Name of ethics committee
Bioethics Committee of Mazandaran University of Medical Sciences
Street address
Moalem Square, Sari, Mazandaran Province
City
sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-06-22, 1400/04/01
Ethics committee reference number
IR.MAZUMS.REC.1400.303
Health conditions studied
1
Description of health condition studied
delirium and sleep quality
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
delirium severity and sleep quality
Timepoint
Baseline (before intervention: T0); Follow-ups For three consecutive nights (from the second night of admission)
Method of measurement
Two Neelon-Champagne Confusion Scale and Verran and Snyder-Halpern Sleep Scale to evaluate delirium severity and sleep quality
Secondary outcomes
empty
Intervention groups
1
Description
The intervention is performed by using eye masks and earplugs from the second night after coronary artery bypass graft surgery for three consecutive nights (from the second night of admission) from 21-22 to 6-7 in the morning by the Caring nurse for the experimental group. paksaman eye masks (Model 504, made in Iran) made of a thin layer of foam covered by a layer of anti-allergy fabric and placed with a soft and light elastic around the head And the classic 3M sponge earplug with 33 dB sound reduction capability will be used.Press the earplug into a spiral and thin, and then by pulling the top of the ear up and back, smooth the ear canal and press the sponge into the ear canal and hold 20-30 until the sponge expands in the ear canal. And after 10 minutes, check if the blindfold eareplug and earmuffs are in place.If necessary, the patient's eye masks and earplug can be removed and reused to communicate with the patient and perform medical and nursing care. The eye mask is disposable, but the blindfold can be used for three nights of intervention.
Category
Prevention
2
Description
The control group also receives only routine ward care without any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital, Sari
Full name of responsible person
seyed afshin shorofi
Street address
Mazandaran, Sari, Imam Hossein Square, Army Boulevard, next to the Blood Transfusion Organization, Fatemeh Zahra Hospital
City
sari
Province
Mazandaran
Postal code
۳۳۱۱۱-۱۴۳۳۹
Phone
+98 11 3332 3023
Email
afshinshorofi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Prof. Majid Saeedi
Street address
sari,Moallem Square
City
sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
msaeedi@mazums.ac.ir
Grant name
Mazandaran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam square, Three-way Joibar, Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
ashorofi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam square, Three-way Joibar, Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
ashorofi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam square, Three-way Joibar, Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
ashorofi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available