The aim of this study is to develop a web application and determine its impact on the college students' stress management.
Design
A randomized clinical trial with a control group, the sample size in each intervention and control groups is 50 students.
Settings and conduct
The study setting will be Shiraz University of Medical Sciences. In this study blinding won't performed.
Participants/Inclusion and exclusion criteria
Students aged between 20-35 years old.
BS students (the second semester and higher) and MS students
Having a smartphone, computer, laptop or tablet
Not suffering from psychological problems known by a physician.
Not taking psychiatric drugs.
Not be addicted according to the students' self expression.
Not having chronic physical illness.
Not having physical limitations.
Intervention groups
In the intervention group, students will use the web application developed in this study for 3 months. This application consists of various parts including metaphors based on theory of Acceptance and Commitment Therapy (ACT), 4-7-8 breathing technique, Emotional Freedom Technique, pictures of nature and relaxing music and videos and in control group students will use an application unrelated to the stress management for 3 months.
Main outcome variables
Perceived stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160427027647N2
Registration date:2020-05-14, 1399/02/25
Registration timing:prospective
Last update:2020-05-14, 1399/02/25
Update count:0
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
Fatemeh Khademian
Name of organization / entity
School of Management and Medical Informatics, Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 0774
Email address
stud2420262816@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-14, 1399/03/25
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development of a web application and studying its effect on the college students' stress management
Public title
The impact of using a web application on college students' stress management
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Students aged 20-35 years old.
BS students ( second and higher semester) and MS students.
Having a smartphone, computer, laptop or tablet.
Not suffering from known psychological problems
Not taking psychiatric drugs.
Not be addicted according to the the students' self expression.
Not having chronic physical illness.
Not having physical disabilities.
Willing to participate in the study.
Exclusion criteria:
Unwillingness to continue the study
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Students in each college will be randomly divided into intervention and control groups using permuted block randomization (5 blocks of size 10). Random Allocation Software will be used to generate the blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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 Sciences
Street address
Zand Av, The Central Building of Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.SUMS.REC.1398.664
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
Z73.3
ICD-10 code description
Stress, not elsewhere classified
Primary outcomes
1
Description
Perceived stress
Timepoint
Before the intervention, after the intervention (3 months later)
Method of measurement
Perceived stress scale questionnaire
Secondary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention, after the intervention (3 months later)
Method of measurement
Pittsburgh Sleep Quality Index
Intervention groups
1
Description
Intervention group: In the intervention group, students will use the web application developed in this study for 3 months. This application consists of various parts including metaphors based on theory of Acceptance and Commitment Therapy (ACT), 4-7-8 breathing technique, Emotional Freedom Technique, pictures of nature and relaxing music and videos.
Category
Behavior
2
Description
Control group: Students will use an application unrelated to stress management for 3 months.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Management and Medical Informatics
Full name of responsible person
Fatemeh Khademian
Street address
Almas Building, Allay 29, Qasrodasht Av
City
Shiraz
Province
Fars
Postal code
۷۱۳۳۶۵۴۳۶۱
Phone
+98 71 3224 0778
Email
fkhademian90@yahoo.com
Web page address
https://mgsch.sums.ac.ir/
2
Recruitment center
Name of recruitment center
School of Health
Full name of responsible person
Fatemeh Khademian
Street address
School of Health, Al-Zahra Street
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3725 1001
Email
fkhademian90@yahoo.com
Web page address
https://schealth.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Zand Av, The Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir/fa/index.html
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
Ramin Ravangard
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Services Management
Street address
Almas Building, Allay 29, Qasrodasht Av
City
Shiraz
Province
Fars
Postal code
۷۱۳۳۶۵۴۳۶۱
Phone
+98 71 3234 0778
Email
ra_ravangard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Agency of Strategic Research in Medical Education
Full name of responsible person
Azam Aslani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
No. 65, Saeedi St, after Ayatollah Hashemi Rafsanjani Crossroads, Valiasr St, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۳۳۶۷۱۳۴۸
Phone
+98 21 2629 2464
Email
azamaslani@gmail.com
Web page address
http://nasrme.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Khademian
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Information Managment
Street address
Almas Building, Allay 29, Qasrodasht Av
City
Shiraz
Province
Fars
Postal code
۷۱۳۳۶۵۴۳۶۱
Phone
+98 71 3234 0778
Email
fkhademian90@yahoo.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
After completion of the study, if necessary, the encoded data will be published along with the article.
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
Yes - There is 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
Title and more details about the data/document
Abstract and references
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Academic Researchers and Academic Institutes
Under which criteria data/document could be used
When referring to this research, mention the name of the researchers.
From where data/document is obtainable
Mailing address, or email address, and phone number, Fatemeh Khademian
What processes are involved for a request to access data/document
First, the applicant requests via email or telephone. It will be answered on demand within 2 months.