The purpose of this study is to design a mobile software to reduce stress and evaluate its impact on the stress of nursing students.
Design
A randomized clinical trial with a control group, the sample size in each intervention and control groups is 68 nursing students.
Settings and conduct
The place of the study will be Kerman University of Medical Sciences. In this study blinding won't performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having the Perceived Stress Scale test score greater than 14, Having a smartphone, passing two academic terms.
exclusion criteria: using other interventions to reduce stress
Intervention groups
In the intervention group, nursing students use computerized mindfulness stress reduction during an eight-week period. In the control group there is no intervention.
Main outcome variables
Perceived Stress Scale test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043756N1
Registration date:2020-03-23, 1399/01/04
Registration timing:registered_while_recruiting
Last update:2020-03-23, 1399/01/04
Update count:0
Registration date
2020-03-23, 1399/01/04
Registrant information
Name
Fatemeh Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5253 2331
Email address
f.jamali@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-18, 1398/11/29
Expected recruitment end date
2020-05-18, 1399/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing a stress reduction mobile application and evaluating its impact on the stress level of nursing students: a clinical trial.
Public title
The effect of Mindfulness base stress reduction software on the stress level of nursing students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the Perceived Stress Scale test score greater than 14
Having smart phones
spending two academic terms
Exclusion criteria:
Using other interventions to reduce stress
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
A specific number of nursing students who have finished two academic semesters and have the perceived stress test scores above 14 ,are divided into two: intervention and control groups by SPSS.
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 Kerman University of Medical Sciences
Street address
At the beginning of Ebn Sina avenue; At the beginning of Jahad boulevard; Somayyeh intersection (Tahmasbabad)
City
Kerman
Province
Kerman
Postal code
03432263719
Approval date
2020-02-02, 1398/11/13
Ethics committee reference number
IR.KMU.REC.1398.555
Health conditions studied
1
Description of health condition studied
stress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders
Primary outcomes
1
Description
Perceived stress scale test score
Timepoint
Before the intervention, after the intervention (eight weeks later), one month after the intervention ended
Method of measurement
Using the Perceived stress scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nursing students who use the Mindfulness-Based Stress Reduction Mobile application, which includes mindfulness techniques. They use it at least 20 minutes daily for eight weeks.
Category
Behavior
2
Description
Control group: There is no intervention in this group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Jamali
Street address
Medical University Campus; Haft-Baghe Alavi Highway
City
Kerman
Province
Kerman
Postal code
7415184771
Phone
+98 71 5253 2331
Email
jamali.hit92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
davood kalantar
Street address
At the beginning of Ebn Sina avenue; At the beginning of Jahad boulevard; Somayyeh intersection (Tahmasbabad)
City
Kerman
Province
Kerman
Postal code
0098342263857
Phone
+98 34 3226 3790
Fax
+98 34 3226 3857
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Jamali
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Health Information Technology
Street address
Ferdowsi street
City
Kerman
Province
Kerman
Postal code
7415184771
Phone
+98 71 5253 2331
Email
jamali.hit92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Jamali
Position
Master of Student
Latest degree
Bachelor
Other areas of specialty/work
Health Information Technology
Street address
Ferdowsi street
City
Kerman
Province
Kerman
Postal code
7415184771
Phone
+98 71 5253 2331
Email
jamali.hit92@jmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Jamali
Position
Master of Student
Latest degree
Bachelor
Other areas of specialty/work
Health Information Technology
Street address
Ferdowsi street
City
Kerman
Province
Kerman
Postal code
7415184771
Phone
+98 71 5253 2331
Email
jamali.hit92@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic variables of students and their perceived stress scale test score are shared without their identification information
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to compare the data from this method with other methods, the data can be shared with other researchers.
From where data/document is obtainable
Dr. Leila Ahmadian, ahmadianle@yahoo.com, Kerman University of Medical Sciences
What processes are involved for a request to access data/document
To receive the data, please contact Dr. Ahmadian via email. After reviewing the request during 4-7 business days , the request will be answered