"Determining the impact of cataract surgery preparedness training through videos on the elderly’s pre-operation anxiety"
"Helping design non-invasive and non-pharmacological interventions to reduce the elderly’s anxiety before this surgery"
"Preventing post-operation complications and faster patient recovery"
"Offering a new approach to national nursing interventions that would introduce this method as a non-pharmacological intervention for the elderly to the managers and nurses of the country in case of its success'
"Providing accurate information regarding the operation room and the type of procedure"
Design
'A clinical trial including a control group with parallel randomized non-blinded groups of 50 patients. Randomization was conducted through permutation blocks"
Settings and conduct
"A clinical trial including a control group with parallel randomized non-blinded groups of 50 patients. Randomization was conducted through permutation blocks"
Participants/Inclusion and exclusion criteria
Patients entering this study must:
"Be over 60 years old"
"Understand and speak Farsi proficiently"
"Be referring for their first cataract surgery"
"Have gained a score of 20 or above from the evident anxiety test evaluated through the Spielberger questionnaire"
"Study exclusion criteria:
"Patient’s withdrawal from the study and change in the surgery date or treatment plan
Intervention groups
The present study first examines patients, evident anxiety through the Spielberger questionnaire. Then, the videos will be played three times for people in the intervention group: at the clinic for the first time, one week later for the second time, and half an hour before the surgery for the last time. No particular training is delivered to those in the control group
Main outcome variables
"The primary variables of the study include the level of anxiety and training"
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201109049315N1
Registration date:2020-12-09, 1399/09/19
Registration timing:prospective
Last update:2020-12-09, 1399/09/19
Update count:0
Registration date
2020-12-09, 1399/09/19
Registrant information
Name
Mozhgan Eftekharpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3333 5914
Email address
mozhganeftekharpoor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-19, 1399/09/29
Expected recruitment end date
2021-02-17, 1399/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
" Comparison of the Impact of Cataract Surgery Preparation Training through Videos on the Elderly’s Pre-operation Anxiety"
Public title
"Comparison of the Impact of Surgery Preparation Training through Videos on Pre-operation Anxiety"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
"Being at least 60 years old"
“Patients referring for their first cataract surgery”
Exclusion criteria:
“Patient’s withdrawal from the study”
“Change in the surgery date or treatment plan”
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
"Permuted block randomization will be used to determine the control and intervention groups. For this purpose, 13 blocks, each made up of four parts, will be selected through sampling with replacement"
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Welfare and Rehabilitation Science
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2020-08-17, 1399/05/27
Ethics committee reference number
IR.USWR.REC.1399.145
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Cataract
ICD-10 code
Z98.4
ICD-10 code description
Cataract extraction status
Primary outcomes
1
Description
"Anxiety score obtained from the Spielberger questionnaire"
Timepoint
"Measurement of patient anxiety at the beginning of the study(before the intervention) and half an hour before the start of surgery"
Method of measurement
"Using the Spielberger Questionnaire"
Secondary outcomes
empty
Intervention groups
1
Description
"The intervention group will be shown the film three times, the first time in the clinic, the second time next week and the third time half an hour before the operation"
Category
Prevention
2
Description
"No training is given to the control group"
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Kowsar Hospital, Semnan
Full name of responsible person
Mozhgan Eftekharpoor Fatemi
Street address
Kowsar Hospital Clinic., Kashef Ave., Amin Blvd., Golestan Town
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7821
Fax
+98 23 3343 7837
Email
Mozhganeftekharpoor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Farahnaz Mohammadi Shahbalaghi
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Fax
+98 21 2218 0109
Email
Mohammadifarahnaz@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Farahnaz Mohammadi Shahbalaghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Fax
+98 21 2218 0109
Email
Mohammadifarahnaz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Farahnaz Mohammadi Shahblaghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Fax
+98 21 2218 0109
Email
Mohammadifarahnaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Farahnaz Mohammadi Shahblaghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Fax
+98 21 2218 0109
Email
Mohammadifarahnaz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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