The effect of using warm compresses on the prevention of keratopathy in patients hospitalized in the special department is determined.
Design
A clinical trial with a control and intervention group and in parallel, one-sided blind, randomized, phase 2 on 48 patients and 98 eyes. R software was used for randomization.مد
Settings and conduct
The intervention is going to be done on 98 eyes and 48 patients hospitalized in the special department of Firoozgar Hospital, where a warm wet compress is placed on the eyelid of one eye, which reaches a temperature of 40 to 45 with a heater device, and the opposite eyelid is closed with glue. In this method, only the Amarist is blinded.
Participants/Inclusion and exclusion criteria
Informed consent of the patient
Not having keratopathy at the beginning of the study based on fluorescein test
No blindness
No injury to the head and face and any trauma that may cause eye damage.
The health of both eyes before hospitalization
Patients with a level of consciousness of 8 and below during the treatment period
Patients who do not have eye diseases
Age range from 18 to 65 years
Admission of patients before 24 hours of hospitalization
Intervention groups
The intended intervention in the sample, in one person, includes the control group and the intervention group, which is the intervention group of the right eye and the opposite eye, which is the left eye, is considered the control group.
Main outcome variables
Preserving tears and preventing tear evaporation; prevention of dry eyes; Prevention of keratopathy.
General information
Reason for update
Acronym
EWKI
IRCT registration information
IRCT registration number:IRCT20240528061933N1
Registration date:2024-06-20, 1403/03/31
Registration timing:registered_while_recruiting
Last update:2024-06-20, 1403/03/31
Update count:0
Registration date
2024-06-20, 1403/03/31
Registrant information
Name
Mohamad Azizkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5607 7057
Email address
kadr.slmt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-07, 1403/03/18
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the warm compress on prevention of keratopathy in patients hospitalized to the intensive care unit
Public title
The effect of the warm compress on prevention of keratopathy in patients hospitalized to the intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of the patient
Age range from 18 to 65 years
No Blindness
No keratopathy at the beginning of the study with fluorescein test
No head injury or trauma that may damage the eyes
Patients who do not have eye diseases
Admission of patients before 24 hours of hospitalization
Patients with a level of consciousness of 8 and below during the treatment period
The health of both eyes before hospitalization
Exclusion criteria:
Reluctance to continue the study for any reason by the patient's legal guardian
Consciousness level above 8 and its fluctuation to above 8
death
discharge
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
48
More than 1 sample in each individual
Number of samples in each individual:
2
Right eye , Left eye.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding is only considered for statistics and is single-blind.
Placebo
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
Golchin, Goghari St., Varzdar St., Talib Lo Alley, Plate 19
City
Tehran
Province
Tehran
Postal code
1366775589
Approval date
2024-06-01, 1403/03/12
Ethics committee reference number
IR.ARAKMU.REC.1403.075
Health conditions studied
1
Description of health condition studied
Keratopathy
ICD-10 code
H06
ICD-10 code description
H00-H06
Primary outcomes
1
Description
Prevention of dry eye syndrome
Timepoint
Examination before and after intervention, intervention for 5 continuous days, 2 times a day, 5 minutes each time.
Method of measurement
Grading scale of corneal changes.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Right eye
Category
Prevention
2
Description
Control group: Left eye
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Mohamad Azizkhani
Street address
No. 19, Taleb Lo Alley, Varzdar Street, Golchin
City
Tehran
Province
Tehran
Postal code
1366775589
Phone
+98 21 5607 7057
Email
kadr.slmt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
koorosh rezaee
Street address
Sardasht, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1366775589
Phone
+98 21 5607 7057
Email
KADR.SLMT@GMAIL.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
80
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
Mohamad Azizkhani
Position
Nurse, graduate student.
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 19, Talib Lo Alley, Varzdar Street, Golchin
City
Tehran
Province
Tehran
Postal code
1366557789
Phone
+98 21 5607 7057
Email
kadr.slmt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamad Azizkhani
Position
nurse, graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golchin, Kadharti, Taleb Lo, plate 19
City
Tehran
Province
Tehran
Postal code
1366557789
Phone
+98 21 5607 7057
Email
kadr.slmt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamad Azizkhani
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golchin, Kadharti, Taleb Lo, plate 19
City
Tehran
Province
Tehran
Postal code
1366557789
Phone
+98 21 5607 7057
Email
kadr.slmt@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD