Protocol summary

Study aim
Determining the effect of multi-media problem solving skill training on the average anxiety caused by COVID-19 in nursing students of Hazrat Fatemeh College of Nursing and Midwifery in Shiraz.
Design
A clinical trial with a control group with parallel groups, double-blind, randomized
Settings and conduct
The place of study is Hazrat Fatemeh Faculty of Nursing and Midwifery, Shiraz University of Medical Sciences. In this study, the participants, the person who collects the information, and the statistician will be blind until the end of the study and the completion of data analysis and reporting.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the students had smart mobile phones and were able to use mobile software. They were known not to suffer from acute psychological diseases. They had not completed another training course in the field of problem solving skills. Exit criteria: the student's unwillingness to continue cooperating in the study; failure to complete the (electronic) questionnaire completely; lack of student anxiety, which is determined based on the score of the questionnaire
Intervention groups
Then multimedia educational content is provided to the participants in the intervention group. After the end of the interventions, in order to comply with the ethical standards, the multimedia educational content is also provided to the control group.
Main outcome variables
Anxiety caused by covid 19

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221207056745N1
Registration date: 2023-01-21, 1401/11/01
Registration timing: registered_while_recruiting

Last update: 2023-01-21, 1401/11/01
Update count: 0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Mohamadreza Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3354 6563
Email address
m.reza.ghasemian1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Problem-Solving Skills Training by multi media on the Level of Anxiety Caused by COVID-19 among Nursing Students of Hazrat Fatemeh School of Nursing and Midwifery in Shiraz
Public title
The Effect of Problem-Solving Skills Training by multi media on the Level of Anxiety Caused by COVID-19 among Nursing Students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Students should have smart mobile phones and be able to use mobile software Not suffering from known acute psychological and cognitive diseases Failure to participate in another training course in the field of problem solving skills
Exclusion criteria:
The student's unwillingness to continue cooperating in the study Failure to complete the (electronic) questionnaire completely Lack of student anxiety, which is determined based on the score of the questionnaire
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
First, we get the distance or k number by dividing the number of members of the studied community by the number of sample members. We prepare a list of sample names. We choose names in equal intervals. Then, using random block software, 66 participants will be randomly placed in two blocks A and B. Using this method, the people assigned to each of the blocks will be equal to 33 people. Finally, they will be placed in two intervention and control groups by using the top coin.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the person who collects the data and the person who performs the data analysis, are blinded to the grouping of the samples into two intervention and control groups.
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 Sciences
Street address
Hazrat Fatima College of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
shiraz
Province
Fars
Postal code
4691758974
Approval date
2022-10-22, 1401/07/30
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1400.004

Health conditions studied

1

Description of health condition studied
Anxiety caused by COVID-19
ICD-10 code
Anxiety
ICD-10 code description
F41.1

Primary outcomes

1

Description
Problem solving
Timepoint
Before the start of the intervention, immediately after the intervention, one month after the end of the intervention
Method of measurement
Questionnaire made by the researcher of demographic information. Corona Disease Anxiety Scale (CDAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The educational content prepared with the help of electronic hub of Shiraz University of Medical Sciences is shared in the form of audio and video files during three 30-minute sessions via mobile phone on WhatsApp social network among the intervention group. And there will be a group question and answer.
Category
Lifestyle

2

Description
Control group: They did not receive any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatemeh School of Nursing and Midwifery affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghasemian
Street address
Hazrat Fatima College of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
m.reza.ghasemian1994@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashem Poor
Street address
Hazrat Fatima College of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
hashempurm@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
Mohamadreza Ghasemian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrat Fatima College of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
m.reza.ghasemian1994@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamadreza Ghasemian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrat Fatima College of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
m.reza.ghasemian1994@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamadreza Ghasemian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrat Fatima College of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
m.reza.ghasemian1994@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
The information obtained from this research will be published in the form of a master's thesis
When the data will become available and for how long
It will be published after the completion of the thesis and the graduation of the student. It is possible to start accessing it from October 1402
To whom data/document is available
Professors and students of medical sciences
Under which criteria data/document could be used
Educational use, educational planning, consulting
From where data/document is obtainable
Hazrat Fatemeh (S) Shiraz College of Nursing and Midwifery Library
What processes are involved for a request to access data/document
People can access the thesis online on the website of the faculty library or visit the library in person
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