Protocol summary

Study aim
This is a double blind clinical trial to evaluate the effect of passive blinking exercises on exposure keratopathy in patients hospitalized in intensive care unit
Design
. 51 anesthetized patients admitted to the intensive department will be selected according Inclusion criteria and using simple sampling and one of the eyes as an intervention group (routine care and passive blinking) and the eye as a control group (routine care alone) Will be taken care.For randomization, in 51 patients, the right eye will be placed in the group A and B with blocking method and The opposite eye will receive the opposite treatment in the right eye.
Settings and conduct
51 anesthetized patients admitted to the intensive department in Arak valiasr haospital will be selected according Inclusion criteria and using simple sampling and one of the eyes as an intervention group (routine care and passive blinking) and the eye as a control group (routine care alone) Will be taken care.In the intervention group, in addition to routine care, the passive blinking by the nurse will be performed with 18 to 20 times for 30 seconds and every 30 minutes. Care will be taken in the left and right eyes simultaneously within a week. All patients will be examined for signs of exposure keratopathy at the beginning of hospitalization. eye examination will be done at the beginning of each day by a person using fluorescein paper and a cobalt filter flashlight, and the results will be recorded immediately. To check keratopathy, an eye specialist will use the scale of corneal changes,In this study, participants and examiners are not aware of the allocation of groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years of age; Unconscious patients with GCS score less than 10 without blinking reaction; No obvious damage to the face and eyes; No dry eyes before admission, According to companions; No history of eye surgery according to companions; Do not use eye drops before admission ,Having no keratopathy at the start of the study Exclusion criteria: discharge or transport from ICU; death; Return of corneal refraction and increased consciousness (GCS score 10 and above). Creating scratches and damage from appliances or other medical errors; Length of stay less than 7 days
Intervention groups
Eye care method in intervention group: 1. Wash hands before eye care. 2. 2. Check daily eyes with fluorescein paper and cobalt filter flashlights. 3. If eyes are closed, two tear drops will be used every four hours. 4. If there is Lagophtalmus, two tear drops every four hours and the use of ophthalmic ointment and Close eyes with glue 5. 5. Cover the eye by pad when suction 6. If there is clear damage (such as white or yellow points on the cornea or redness, swelling and conjunctivitis), be advised to the physician. In addition to care, passive blinking by the nurse will be carried out with 18 to 20 times for 30 seconds and every 30 minutes. Eye care method in control group: 1. Wash hands before eye care. 2. 2. Check daily eyes with fluorescein paper and cobalt filter flashlights. 3. If eyes are closed, two tear drops will be used every four hours. 4. If there is Lagophtalmos , two tear drops every four hours and the use of ophthalmic ointment and Close eyes with glue 5. 5. Cover the eye by pad when suction 6. If there is clear damage (such as white or yellow points on the cornea or redness, swelling and conjunctivitis), be advised to the physician. .
Main outcome variables
Severity of exposure keratopathy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180107038251N1
Registration date: 2018-03-05, 1396/12/14
Registration timing: retrospective

Last update: 2018-03-05, 1396/12/14
Update count: 0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Nazanin Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 1308
Email address
nazaninamini69@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
2016-12-20, 1395/09/30
Actual recruitment end date
2017-07-21, 1396/04/30
Trial completion date
empty
Scientific title
The effect of passive blinking exercises on exposure keratopathy in patients hospitalized in intensive care unit
Public title
"The effect of passive blinking on incidence of exposure keratopathy "
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age; Unconscious patients with GCS score less than 10 without blinking reaction; No obvious damage to the face and eyes; No dry eyes before admission, According to companions; No history of eye surgery according to companions; Do not use eye drops before admission , Having no keratopathy at the start of the study
Exclusion criteria:
discharge or transport from ICU; death; Return of corneal refraction and increased consciousness (GCS score 10 and above); Creating scratches and damage from appliances or other medical errors; Length of stay less than 7 days;
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 51
More than 1 sample in each individual
Number of samples in each individual: 2
In the control eye , routine care is performed and in intervention eye, in addition to care, passive blinking by the nurse is performed with 18 to 20 times for 30 seconds and every 30 minutes.
Actual sample size reached: 51
More than 1 sample in each individual
Actual sample size in each individual: 2
In the control eye , routine care is performed and in intervention eye, in addition to care, passive blinking by the nurse is performed with 18 to 20 times for 30 seconds and every 30 minutes.
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization, In this method, 51patients placed the right eye in a group A and B blocking method, and the opposite eye received Inverse treatment in the right eye.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, examiners are not aware of the allocation of groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
•Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,Arak,Iran
City
Arak
Province
Markazi
Postal code
1234
Approval date
2016-11-10, 1395/08/20
Ethics committee reference number
IR.ARAKMU.REC.1395.305

Health conditions studied

1

Description of health condition studied
Exposure keratopathy
ICD-10 code
H15-H22
ICD-10 code description
Disorders of sclera, cornea, iris and ciliary body

Primary outcomes

1

Description
Exposure keratopathy severity
Timepoint
Before the study, every morning to 1 week
Method of measurement
Examination with fluorescein paper, and flashlight with cobalt blue light filter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1. Wash hands before eye care.2. 2. Check daily eyes with fluorescein paper and cobalt filter flashlights.3. If eyes are closed, two tear drops will be used every four hours.4. If there is Lagophtalmus, two tear drops every four hours and the use of ophthalmic ointment and Close eyes with glue5. 5. Cover the eye by pad when suction6. If there is clear damage (such as white or yellow points on the cornea or redness, swelling and conjunctivitis), be advised to the physician.In addition to care, passive blinking by the nurse will be carried out with 18 to 20 times for 30 seconds and every 30 minutes.
Category
Prevention

2

Description
Control group: 1. Wash hands before eye care.2. 2. Check daily eyes with fluorescein paper and cobalt filter flashlights.3. If eyes are closed, two tear drops will be used every four hours.4. If there is Lagophtalmus, two tear drops every four hours and the use of ophthalmic ointment and Close eyes with glue5. 5. Cover the eye by pad when suction6. If there is clear damage (such as white or yellow points on the cornea or redness, swelling and conjunctivitis), be advised to the physician.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Nazanin Amini
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,Arak,Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3507
Email
nazaninamini69@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mr.Nasri
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences,Sardasht,Arak,Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3505
Email
nazaninamini69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Nazanin Amini
Position
MSc in Nursing
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,Arak,Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3507
Email
nazaninamini69@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Position
MSc in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,Arak,Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3524
Email
k.rezaei@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazanin Amini
Position
MSc in Nursing
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,Arak,Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3505
Email
nazaninamini69@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
2018
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
I have no conditions
From where data/document is obtainable
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street Arak, Markazi Province, Iran
What processes are involved for a request to access data/document
Visit to Arak Medical University, Faculty of Paramedicine,Anesthesiology Department, Ms. Amini
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