Determining the effect of short educational video on anxiety before cataract surgery by Fico method
Design
Clinical trial with control group, double-blind, 80 people in each group at random
Settings and conduct
After receiving the code of ethics from the research deputy, the researcher will refer to the Abu Reihan subspecialty clinic, and after obtaining the written informed consent of the research units, he will intervene. In this way, patients who met the inclusion criteria will be selected by simple random sampling and will be divided into two groups of test and control. After filling out the questionnaires, a 10-minute short training video on Fico surgery will be shown to the experimental group and explanations about Fico surgery will be given to the control group on a routine basis. On the day of surgery The researcher referred to the research environment again and completed the questionnaires 1 hour before the patient went to the operating room for phaco surgery.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Participants are both male and female, have full consent to participate in the study, the presence of the disease in them is confirmed by an ophthalmologist and patients with cataracts, familiar with the Persian language and the ability to read and write, in the range Are aged 75-20 years.
Exclusion Criteria: Severe psychiatric disorders such as psychotic disorders and panic disorder, incurable physical diseases, History of drug use
Intervention groups
The intervention in the present study is a short educational video on anxiety before cataract surgery by Fico method. The control group receives routine preoperative care.
Main outcome variables
The anxiety of patients who are candidates for cataract surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046145N1
Registration date:2020-09-05, 1399/06/15
Registration timing:retrospective
Last update:2020-09-05, 1399/06/15
Update count:0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Dorna Sattar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 0823
Email address
dornasattar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational video on preoperative anxiety of Phico-cataract patients
Public title
The effect of educational video on preoperative anxiety in patients with cataract
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Participants are both male and female
Have full satisfaction to participate in the research
Have a file in the Abu Reihan subspecialty clinic in Tehran in the year 1997-98
The presence of the disease in them should be confirmed by an ophthalmologist and patients should have cataracts
Familiar with Persian language and ability to read and write
Be in the age range of 75-20 years
Exclusion criteria:
Severe psychiatric disorders such as psychotic disorders and bipolar disorder
Having incurable physical diseases such as cancer
History of drug use
Age
From 20 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The statistician, patients, and nurses who measured the variables were unaware of the randomization of the samples, so that patients only knew that they had participated in the study but did not know which group they belonged to. The data were also coded to the statistician and the type of group was not mentioned to the statistical analyzer, but the researcher was aware of the randomization of the samples. Therefore, two-way study is considered blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Medical Sciences, Tehran
Street address
Islamic Azad University of Tehran Medical Sciences Branch, Khaghani St, Shariati Ave
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2019-11-20, 1398/08/29
Ethics committee reference number
IR.IAU.TMU.REC.1398.147
Health conditions studied
1
Description of health condition studied
Anxiety of patients undergoing cataract surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
At the beginning of the study and one day after showing the short educational video (one hour before surgery)
Method of measurement
Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention of the present study will be a short educational video (10 minutes) about cataract surgery by Fico method. The content of the educational video will be about how and when to perform fico surgery and pre- and post-operative care
Category
N/A
2
Description
Control group: The control group received only routine nursing care and was given the usual training on cataract surgery orally.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Reihan Clinic of the Social Security Organization
Full name of responsible person
Dorna Sattar
Street address
Abu Reihan Clinic of the Social Security Organization, Palestine St, Enghelab Ave,
City
Tehran
Province
Tehran
Postal code
1315794831
Phone
+98 21 6617 5379
Email
dornasattar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Islamic Azad University of Medical Sciences Tehran, Khaghani St,Shariati Av
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2264 0599
Email
fhashemian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Medical Sciences, Tehran
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
Islamic Azad University
Full name of responsible person
Dorna Sattar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Abu Reihan Clinic of the Social Security Organization, Enghelab St, Palestine Ave
City
Tehran
Province
Tehran
Postal code
1315794831
Phone
+98 21 6617 5379
Fax
Email
dornasattar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
dornasattar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Abu Reihan Clinic of the Social Security Organization, Palestine St, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1315794831
Phone
0098 66175379
Email
dornasattar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dorna Sattar
Position
Bachelor of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Abu Reihan Clinic of the Social Security Organization, Palestine St, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1315794831
Phone
+98 21 6617 5379
Email
dornasattar@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
There is no more information
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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available