Determination and comparison of students' angre in the case and control group before and after using the Echium Amoenum
Design
A clinical trial with a control group,randomization
Settings and conduct
The researcher, after the official permission of the Islamic Azad University of Kerman Branch, conducted a preliminary interview with nursing students in accordance with ethical standards and according to pre-determined criteria, and explained the purpose of the research to them. Then anger questionnaire was completed by them. For those who scored below the average level, they were asked to complete the written consent form, then randomly divided into two groups.
Participants/Inclusion and exclusion criteria
The disease has no physical history. Desire to collaborate on research Do not have a history of acute and chronic mental and psychological problems. Have not participated in another research No history of drug use The absence of a specific patient in the family No divorce or death of family members Non-arrival conditions: Taking any medication pregnancy
Intervention groups
Intervention group:Pour 1 g of Echium amoenum powdered in 250 cc of boiling water and use after 10 minutes of oral and daily doses were taken for four weeks. control group:Does not receive anything.
Main outcome variables
Anger
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130615013677N4
Registration date:2020-09-22, 1399/07/01
Registration timing:retrospective
Last update:2020-09-22, 1399/07/01
Update count:0
Registration date
2020-09-22, 1399/07/01
Registrant information
Name
Somayeh Soltani Nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 5500
Email address
s.soltaninejad@iauba.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-08-23, 1398/06/01
Trial completion date
2019-08-23, 1398/06/01
Scientific title
Study of the effect of Echium Amoenum on controlling Students' Anger
Public title
Effect of Echium amoenum on anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The disease has no physical history
Desire to collaborate on research
Do not have a history of acute and chronic mental and psychological problems.
Have not participated in another research
No history of drug use
The absence of a specific patient in the family
No divorce or death of family members
Exclusion criteria:
Pregnancy
Taking any medication
Age
From 19 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this part, a simple randomization method was used. Randomization was individual and the lottery tool was used
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
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.KMU.REC.1397.549
Health conditions studied
1
Description of health condition studied
Anger
ICD-10 code
R45.4
ICD-10 code description
Irritability and anger
Primary outcomes
1
Description
Anger
Timepoint
Before the intervention and one month later
Method of measurement
STAXI-2 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The consumption of Echium amoenum was carried out in such a way that one gram of powdered Echium amoenum powder was poured into 250 cc of boiling water and after 10 minutes, the beverage was consumed orally each day for one month. At the end of the first, second and third weeks, the samples were evaluated to ensure proper use of Echium amoenum, and at the end of the fourth week, the second test was re-tested, both in the two stages of the scoring method. In the control group, the interval between two tests was one month.
Category
Other
2
Description
Control group: The subjects first completed the questionnaire and were followed by a researcher to avoid any physical or mental problems. After a month, they completed the questionnaire again.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University Kerman
Full name of responsible person
Somayeh soltaninejad
Street address
Islamic Azad University Kerman Branch University Blvd, Emam Ali, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3321 0043
Email
soltaninejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Kazemi
Street address
Islamic Azad University Kerman Branch University Blvd, Emam Ali, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3321 0043
Email
soltaninejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
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
Islamic Azad University
Full name of responsible person
Somayeh Soltaninejad
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University Kerman Branch University Blvd, Emam Ali, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3321 0043
Email
soltaninejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Soltaninejad
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University Kerman Branch University Blvd, Emam Ali, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3321 0043
Email
soltaninejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Soltaninejad
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Islamic Azad University Kerman Branch University Blvd, Emam Ali, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3321 0043
Email
soltaninejad@yahoo.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
Yes - There is 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
Information about the outcome of the research
When the data will become available and for how long
Start access after printing the article
To whom data/document is available
researchers، Participants in research
Under which criteria data/document could be used
The requesting person is allowed to use the research results, the resources used, the questionnaires.
From where data/document is obtainable
somayeh soltaninejad soltaninejad@yahoo.com
What processes are involved for a request to access data/document
After sending an email, it will take less than a week to reach the individual