A comparative Study on the effect of anxiety management training on two methods of Microlearning and a Gamification based website on anxiety control in 13-15 years old adolescent girls in Shiraz
Comparison of the effect of anxiety management training on two methods of Microlearning and a Gamification based website on anxiety control in 13-15 years old adolescent girls in Shiraz
Design
Clinical trial dedicated to intervention and control groups (totally design of 400 patients), based on community and training-counseling, with parallel groups, no blind groups, Randomized cluster
Settings and conduct
The effect of two methods of Microlearning & Gamification is used to reduce anxiety of adolescent girls.The place of execution is Shiraz girls' schools.The Spielberger questionnaire measures anxiety level of them & in case of mild to moderate anxiety, they enter into one of 3 groups: MicroLearning, Gamified training, control group. At the end, Spielberger Questionnaire will be completed again.
Participants/Inclusion and exclusion criteria
Inclusion criterias:
1-Girls aged 13 to 15 years old who study in schools of Shiraz
2-Obtain a score of 20 to 80 from the Spielberger anxiety inventory (mild to severe anxiety)
3-The desire to collaborate and participate in research and parents' satisfaction with how research is conducted
4-Ability to work with computers.
Exit criterias:
1-Do not participate in one of the pre- or post-test sessions
2-History of mental disorders and use of sedation drugs
3-Experience the crisis, during the intervention or 40 days before
Intervention groups
1-anxiety management training group with method of Microlearning: View short video clips online and through a regular website that will take 4 weeks, and almost 2 videos will be on the website per week.
2-The group receives anxiety management training on the method of Gamification: Watching short clips through a Gamified website that will take 4 weeks and almost 2 videos will be on the website per week.
3-Control group: A group that does not get online education
Main outcome variables
Control the anxiety of teenage girls
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041887N1
Registration date:2019-01-10, 1397/10/20
Registration timing:prospective
Last update:2019-01-10, 1397/10/20
Update count:0
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
Elham Saranjam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3831 0420
Email address
saranjam@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative Study on the effect of anxiety management training on two methods of Microlearning and a Gamification based website on anxiety control in 13-15 years old adolescent girls in Shiraz
Public title
A comparative study on the effect of anxiety management training on anxiety control in 13-15 years old adolescent girls
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
13-15 years old girl students in Shiraz
Get score between 20 to 80 from the Spielberger's Anxiety Inventory (Mild to Severe anxiety)
The desire to collaborate and participate in research and parents' satisfaction of How to do research
Ability to work with computers
Exclusion criteria:
Do not participate in one of the pre or post-test sessions
History of mental disorders or using sedations
Experience the crisis, during the intervention or 40 days before
Age
From 13 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
First, a randomly cluster will be selected from the four education districts of Shiraz, from which three state-run girls' schools will be selected by systematic random sampling and then from each school in a randomized, three class (of each Grade, one class) will be selected. After receiving informed consent, the Spielberger Anxiety Inventory is presented to them. Adolescents who have entered the study criteria and have received the above questionnaire for mild anxiety score are selected to enter the study. And these teenagers are randomly assigned to three groups of Microlearning, Gamification and Control.
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 Shiraz University of Medical Sceience
Street address
Central Building of Shiraz University of Medical Science, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.SUMS.REC.1397.897
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
The effect of Microlearning on anxiety management of adolescent girls
Timepoint
Before the intervention, Immediately after and two weeks after the intervention
Method of measurement
Spielberger Anxiety Inventory (state and trait anxiety)
2
Description
The Effect of method of Gamification on Anxiety Management of Adolescent Girls
Timepoint
Before the intervention, Immediately after and two weeks after the intervention
Method of measurement
Spielberger Anxiety Inventory (state and trait anxiety)
Secondary outcomes
empty
Intervention groups
1
Description
The first Intervention group: The recipient of anxiety management trainings on the method of Microlearning
Category
Behavior
2
Description
The second Intervention group: The recipient of anxiety management trainings on the method of Gamification based website
Category
Behavior
3
Description
Control group: No recieving anxiety management trainings
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls' schools of Shiraz
Full name of responsible person
Dr.Askar Najafi
Street address
General Education Department of Fars Province, East Moaddel St
City
Shiraz
Province
Fars
Postal code
71345-314
Phone
+98 71 3233 5953
Email
public_ir@farsedu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Ali Bahador
Street address
Research assisstance, Shiraz University of Medical Science, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Elham Saranjam
Position
Master student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Namazai Sq
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 713230541019
Email
saranjam@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ladan Zarshenas
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Nursery
Street address
Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
zarshenas@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Saranjam
Position
Master student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Namazi Square
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
Saranjam@sums.ac.ir
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