Effect of eyes irrigation by brewed black tea on theonset of redness, inflammation and purulent secretion in patients hospitalized in intensive care units
Methodology: The study is a clinical trial, double-team with randomized allocation groups, done in two medical centers. Forty patients hospitalized in intensive care units after adaptation with inclusion and exclusion criteria including the absence of any trauma or injury to the eye and absence of signs of the study will randomly allocate into two groups to participate in the study if they consent to do so. In the intervention group, in addition to usual ICU eye care routine, one cc of brewed black tea for each eye will be applied once a day for 7 days. In the control group with the same conditions, the physiologic serum of 1 cc will be used to wash the patients’ eyes instead of tea. In both groups on days 1, 3 and 7 the patients’ eyes will be monitored, with examination criteria such as redness, eye discharge and inflammation of the eye. Symptoms will be recorded then the target samples will be removed from the rest of the investigation. In performing this teamwork-based research, the intervention is done by the main researcher, the co-researcher is responsible for the patients' monitoring and the data will be analyzed by statistics adviser as blind people in a double-blind framework.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610209664N6
Registration date:2017-07-12, 1396/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-12, 1396/04/21
Registrant information
Name
Mitra Payami Bousari
Name of organization / entity
Zanjan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6962
Email address
payami@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Zanjan University of Medical sciences
Expected recruitment start date
2016-01-26, 1394/11/06
Expected recruitment end date
2016-03-02, 1394/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of eyes irrigation by brewed black tea on theonset of redness, inflammation and purulent secretion in patients hospitalized in intensive care units
Public title
Effect of eyes irrigation by brewed black tea on eye inflammation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Lack of eye injury and trauma; lack of congenital eye disease; no symptoms of redness; swelling and discharge at the time of sampling.
Exclusion criteria: need to tarsurafy; possible allergic to tea extract; need for using Immunosuppressive drugs; consent from the patient or the patient's parents participate in the study; transfer the patient or died during intervention.
Age
From 23 years old to 83 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization using number assigned from one to forty, then using the table of random numbers. Blinding via Failure to inform patients about the type of washing solution and preventing the researcher and co-researcher from confrontation to intervention and patients monitor
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Office of Student Research Committee, School of Medicine, Zanjan University of Medical Sciences, employees town ,the end of the Mahdavi boulevard, Zanjan, Iran
City
zanjan
Postal code
4513956113
Approval date
2015-10-07, 1394/07/15
Ethics committee reference number
ZUMS.REC.1394.185
Health conditions studied
1
Description of health condition studied
Symptoms include redness, inflammation and purulent secretion
ICD-10 code
H57.9
ICD-10 code description
Disorder of eye and adnexa; unspecified
Primary outcomes
1
Description
Eye inflammation
Timepoint
Days 1st, 3th and 7th from the onset of the study
Method of measurement
Physical visit
2
Description
Eye purulent secretion
Timepoint
Days 1st, 3th and 7th from the onset of the study
Method of measurement
Physical visit
3
Description
Eye redness
Timepoint
Days 1st, 3th and 7th from the onset of the study
Method of measurement
Physical visit
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, in addition to usual ICU eye care routine including washing the eyes by artificial tears every six hours, 1cc of brewed black tea for each eye around ten o'clock in the morning will be applied once a day for 7 days.
Category
Prevention
2
Description
In the control group with the same conditions, in addition to the routine eye care which includes washing the eyes by artificial tears once per each 6 hours, the physiologic serum of 1 cc will be used to wash the patients’ eyes instead of tea in the morning about ten o'clock daily.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Vali-e-Asr Hospital
Full name of responsible person
Dr.rostamkhani
Street address
Hazrat Vali-e-Asr Hospital, after ValiAsr Sq., Zanjan, Iran
Vice Chancellor for Research, Zanjan University of Medical Sciences
Full name of responsible person
Dr. Korosh Amini
Street address
Vice Chancellor for Research and Technology, Second floor, Building No.1, The Central building of Zanjan University of Medical Sciences, Azadi Sq., Zanjan, Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences
Full name of responsible person
Ghazale Sattari
Position
Master of science student in Critical Nursing Care