determining the effect of showing educational videos On the level of anxiety of mothers referred to preoperative anesthesia clinic
Design
Clinical trial with control group,
With parallel groups, double blinded
that the patient and the person completing the questionnaires are unaware of the intervention.
Randomization is depending on the clinic's number of shifts given to each patient,
Couples are in the control group and the individual numbers are in the intervention group.
Settings and conduct
This study will be performed on the mothers of patients referred to the anesthesia clinic of the Children's Medical Center Hospital.
The demographic checklist is completed for everyone and
then an instructional video will be shown for the intervention group.
After the pre-anesthesia visit, the level of anxiety in both groups will be measured by 21 Beck Anxiety questionnaire.
Participants/Inclusion and exclusion criteria
inclusion criteria is the mothers of all the patients will be referred to the anesthesia clinic of the medical center hospital for a preoperative visit. The ability to speak and understand Persian fluently, ability to take care of yourself and your baby, lack of mental and physical illness and be literate. the exclusion criteria include history of abortion in the mother Physical and mental problems in the child (mental retardation, cerebral palsy and chronic congenital defects) Incurable disease of the child.
Intervention groups
En In this study, randomization by odd even and odd numbers and showing videos to members of the intervention group was done by general Practitioner in the waiting room. Analysis of questionnaires of the intervention and control group was performed by anesthesiologist.
Main outcome variables
Investigating the effect of showing educational videos on the level of anxiety of mothers of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200521047530N1
Registration date:2020-07-15, 1399/04/25
Registration timing:registered_while_recruiting
Last update:2020-07-15, 1399/04/25
Update count:0
Registration date
2020-07-15, 1399/04/25
Registrant information
Name
Nima Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6147 2569
Email address
n-nazari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of showing educational videos On the level of anxiety of mothers referred to preoperative anesthesia clinic
Public title
Investigating the effect of showing educational videos On the level of mothers anxiety
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The mothers of all the patients will be referred to the anesthesia clinic of the medical center hospital for a preoperative visit.
The ability to speak and understand Persian fluently, ability to take care of yourself and your baby, lack of mental and physical illness and be literate
Exclusion criteria:
the exclusion criteria include history of abortion in the mother
Physical and mental problems in the child (mental retardation, cerebral palsy and chronic congenital defects)
Incurable disease of the child
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization by odd even and odd numbers and showing videos to members of the intervention group was done by general Practitioner in the waiting room.
Blinding (investigator's opinion)
Double blinded
Blinding description
For this study, blinding will be done as a two blind study. Dividing the participants into two groups and showing the video was done by the medical student and evaluation of all participants was done by an anesthesiologist. Participants did not know how the intervention worked and the anesthesiologist (evaluator) does not know which client the film is shown to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Qods st
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-05-21, 1399/03/01
Ethics committee reference number
IR.TUMS.CHMC.REC.1399.025
Health conditions studied
1
Description of health condition studied
mother's anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in Beck questionnaire
Timepoint
Anxiety measurement when visiting a pre-anesthesia clinic
Method of measurement
Beck Anxiety Questionnaire
Secondary outcomes
1
Description
Beck's questionnaire anxiety score
Timepoint
Measuring the Beck Anxiety Score when the patient's mother enters the anesthesia clinic
Method of measurement
Questionnaire 21 Beck Anxiety Questions
Intervention groups
1
Description
Intervention group: Show the instructional video of about 5 minutes prepared by the researcher herself including the preoperative sedation process,taking IV under inhalation induction, then general sedation or anesthesia, and recovery phase
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Childrens Medical Center Hospital
Full name of responsible person
Dr. Nima Nazari
Street address
Dr. Gharib st, Childrens Medical Center Hospital
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2569
Email
cmcpr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Nima Nazari
Street address
Keshavarz Blvd, Qods St
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Nima Nazari
Position
assistant professor, anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Dr. Gharib st, Childrens Medical Center Hospital
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2569
Email
nima.nazari1366@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Nima Nazari
Position
Assistant Professor, Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Dr. Gharib st, Childrens Medical Center Hospital
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2569
Email
nima.nazqari1366@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Nima Nazari
Position
assistant professor, Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Dr. Gharib st, Childrens Medical Center Hostital
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2569
Email
nima.nazari1366@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The checklist and anxiety questionnaire of the subjects studied can be shared.
When the data will become available and for how long
Access starts 6 months after printing the results.
To whom data/document is available
The data will be available to researchers working at academic and scientific institutions.
Under which criteria data/document could be used
Data if needed, after correspondence and announcement of the cause of the need, the data will be made available to them.
From where data/document is obtainable
Dr. Nima Nazari
Childrens Medical Center Hospital
00982161472569
nima.nazari1366@gmail.com
What processes are involved for a request to access data/document
The request will be sent to the respondent's e-mail and the documents will be submitted within 5 working days.