Protocol summary

Study aim
The effect of blinking exercise training on the signs and symptoms of dry eye
Design
Clinical trial with control group, with two intervention groups and control group, double blind, randomized on 144 patients. Matlab software was used for randomization.
Settings and conduct
Patients were randomly selected and after obtaining informed consent, they entered the study and were placed in three groups of 48 people. The first group receives self-care training and blinking exercises, the second group receives self-care training, and the control group receives routine treatments.
Participants/Inclusion and exclusion criteria
Having dry eye; treated for at least 6 months; ages 15-51 years old; not using of systemic drugs with ocular complications; no failure of the lacrimal glands; no recent ocular surgery; no thyroid disorders.
Intervention groups
For patients in intervention group A, a training program on dry eye disease, self-care, medication use, and compliance with items that control the signs and symptoms of the disease, as well as how effective eyelid blinking is taught and performed by the facilitator. It is asked to repeat this operation several times, then its accuracy is evaluated and confirmed by the researcher. Full blinking is performed 24 times in at least 30 seconds by the intervention group A. We ask them to do this exercise every half hour during the day and wake up. In order to investigate the effect of active blinking on the signs and symptoms of dry eye, to a group of patients (group B), only trainings related to recognizing dry eye disease, self-care, and medication use (as in group A patients) by the presenter Can. There is no intervention for patients in the control group, and only the training and treatment usually performed by a doctor or nurse is controlled and recorded.
Main outcome variables
Signs and symptoms of dry eye

General information

Reason for update
Acronym
EBETSDES
IRCT registration information
IRCT registration number: IRCT20200519047512N1
Registration date: 2021-03-16, 1399/12/26
Registration timing: registered_while_recruiting

Last update: 2021-03-16, 1399/12/26
Update count: 0
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
somayeh khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4242 5196
Email address
s.khademi9511@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-15, 1399/12/25
Expected recruitment end date
2021-04-14, 1400/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of blinking exercise training on sign and symptoms of dry eye syndrome
Public title
Effect of blinking exercise training on sign and symptoms of dry eye syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Dry eye should be confirmed by the diagnosis of an ophthalmologist using clinical signs and symptoms, a schirmer test, and tear break up time. Has been treated for at least 6 months. Age 15-51 years old. Do not use systemic drugs with associated eye effects.(such as β - blockers  Diuretics, Antihistamines, TCAs, androgens, Isotretinoin Do not have primary, secondary, or obstructive insufficiency Tear glands. Do not undergo eye surgery. Do not have thyroid disorders.
Exclusion criteria:
If do not do more than third Practice during the day (The patient is asked). Death or transfer of residence. Having any disease that requires medication, hospitalization, or surgery. Get any new eye problems.
Age
From 15 years old to 51 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
In the block method, the volume of each block must first be specified. In this study, groups can be in three states It has been replaced in the form of ABC(1), BCA(2), CBA(3), BAC(4), ACB(5), CAB(6) Which are randomly selected And are placed in 24 blocks of 6 to complete each block. All block randomization steps using From matlab software by a statistician Perform and list samples It will be given to the researcher.
Blinding (investigator's opinion)
Double blinded
Blinding description
Sampling, completion of pre-test questionnaires and training of groups A and B are performed by the facilitator. In order to prevent bias post-test information, post-test questionnaires are completed by a research colleague who is unaware of intervention groups A, B and control.
Placebo
Not used
Assignment
Parallel
Other design features
...

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical sciences
Street address
Payambar Aazam (SAW) University complex, Basij Squ., Sardasht region
City
Saveh
Province
Markazi
Postal code
3914334911
Approval date
2021-02-16, 1399/11/28
Ethics committee reference number
IR.ARAKMU.REC.1399.314

Health conditions studied

1

Description of health condition studied
Dry eye
ICD-10 code
H04.1
ICD-10 code description
Dry eye syndrome

Primary outcomes

1

Description
Dry eye score in the OSDI questionnaire
Timepoint
Before the intervention and 7 days after the intervention
Method of measurement
OSDI questionnaire

2

Description
Dry eye rate in schirmer test and tear break up time
Timepoint
Before the intervention and 7 days after the intervention
Method of measurement
schirmer test

3

Description
Dry eye rate in tear break up time
Timepoint
Before the intervention and 7 days after the intervention
Method of measurement
Tear break up time test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For Intervention Group A patients, a training program on dry eye disease, self-care, medication use, and compliance with items that control the symptoms and signs of the disease, as well as effective eyelid blinking by the instructor taught them They are asked to repeat this operation several times, then its accuracy is evaluated and confirmed by the researcher.
Category
Lifestyle

2

Description
Intervention group: Second Intervention Group: In order to investigate the effect of active blinking on the signs and symptoms of dry eye, to a group of patients (group B), only training related to recognizing dry eye disease, self-care, and medication use (as in group A patients). ) Provided by the executor.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Modares hospital
Full name of responsible person
Somayeh Khademi
Street address
No. 1, Modarres blvd., Motahari St.,
City
Saveh
Province
Markazi
Postal code
3915617157
Phone
+98 86 4222 2042
Fax
+98 86 4222 3321
Email
s.khademi9511@gmail.com
Web page address
https://fa.irct.ir/user/trial/48474/update/recruitment_center

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Reza Kamali
Street address
Payambar Aazam (SAW) University complex, Basij Squ., Sardasht region
City
Arak
Province
Markazi
Postal code
3914334911
Phone
+98 86 3417 3505
Fax
+98 86 3417 3505
Email
s.khademi9511@gmail.com
Web page address
https://www.arakmu.ac.ir/
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
Kurosh Rezaie
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Payambar Aazam (SAW) University complex, Basij Squ., Sardasht region
City
Arak
Province
Markazi
Postal code
3914334911
Phone
+98 86 3417 3505
Fax
+98 86 4222 3321
Email
s.khademi9511@gmail.com
Web page address
https://www.arakmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Somayeh Khademi
Position
Nurssing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Payambar Aazam (SAW) University complex, Basij Squ., Sardasht region
City
Arak
Province
Markazi
Postal code
3914334911
Phone
+98 86 3417 3505
Fax
+98 86 4222 3321
Email
s.khademi9511@gmail.com
Web page address
https://www.arakmu.ac.ir/fa

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Somayeh Khademi
Position
Nurssing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Payambar Aazam (SAW) University complex, Basij Squ., Sardasht region
City
Arak
Province
Markazi
Postal code
3914334911
Phone
+98 86 3417 3505
Fax
+98 86 4222 3321
Email
s.khademi9511@gmail.com
Web page address
https://www.arakmu.ac.ir/fa

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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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