Protocol summary

Study aim
Providing a simple and useful executive solution to raise of awareness and motivate the use of caring behaviors in mothers of children with urinary tract infection.
Design
Clinical trials without control group, single blind, uncontrolled placebo, multi-centered, one stage of trial.
Settings and conduct
The present study will be conducted at Amir Kabir Hospital and Emam Reza Clinic in Arak and samples will not know how to place the samples in the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The desire to participate in the study Diagnosis of childhood urinary tract infection by a specialist Reading and writing skills Having a mobile phone equipped with Telegram software Exclusion criteria: Unwilling to participate in research Other illnesses leading to hospitalization No refer to the physician to follow the training program
Intervention groups
In both groups, before the intervention, the method, goals, and confidentiality of the individual information of the participants are explained to them and informed consent is obtained. Then, both groups completed demographic information questionnaire, maternal awareness questionnaire and maternal care behaviors questionnaire. First intervention group: After completing the first stage questionnaire, mothers will have a face-to-face training session for 45 minutes each person-to-person with a pamphlet summarizing the educational content. Second intervention group: The group will receive similar training through telegram messages within three days and they will be required to inform the researcher about the daily receipt and viewing of messages through a message.
Main outcome variables
awareness and caring behaviors in mothers of children with urinary tract infection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171111037377N2
Registration date: 2018-02-27, 1396/12/08
Registration timing: registered_while_recruiting

Last update: 2018-02-27, 1396/12/08
Update count: 0
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
z.zeinali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of education through social network and face to face on the awareness and caring behaviors in mothers of children with urinary tract infection
Public title
Comparison of the effect of education through social network and face to face on the awareness and caring behaviors in mothers of children with urinary tract infection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to participate in the study Diagnosis of childhood urinary tract infection by a specialist; Reading and writing skills Not having mental illness or physical problems Unemployment as health care personnel Having a cell phone equipped with Telegram software Not attending similar training classes
Exclusion criteria:
Unwilling to continue of research Exit from the city and lack of access Failure to complete the second stage of questionnaire No refer to the physician to follow the training program Other illnesses leading to hospitalization
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are divided into intervention and control groups using randomized block allocation method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Initially, the purpose of the study and how it is done for the samples is described, but the samples will not know how to allocate to the 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 Arak University of Medical Sciences
Street address
Aalam al-Hoda St, Rah ahan Sq
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.ARAKMU.REC.1396.182

Health conditions studied

1

Description of health condition studied
Urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified

Primary outcomes

1

Description
Awareness and caring behaviors in mothers of children with urinary tract infection
Timepoint
Before intervention and one month after intervention
Method of measurement
Mothers Awareness Questionnaire and Mothers' Care Behaviors Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: After completing the first stage questionnaire, mothers will have a face-to-face training session for 45 minutes each person-to-person with a pamphlet summarizing the educational content.
Category
Lifestyle

2

Description
Second intervention group: The group will receive similar training through telegram messages within three days and they will be required to inform the researcher about the daily receipt and viewing of messages through a message.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir kabir Hospital in Arak
Full name of responsible person
Dr. Alireza Kamali
Street address
Alam-alhoda St, Rah ahan Sq
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4715
Email
info@arakmu.ac.ir

2

Recruitment center
Name of recruitment center
Emam Reza Clinic
Full name of responsible person
Seyed Morteza Navabi
Street address
Khorram St,
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
manager_clinic@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Argmandzadegan
Street address
Basij Sq, Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3645
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zahra Zeinali
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak School of Nursing and Midwifery, Basij Sq, Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
zeynali287@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Zeinaly
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq, Sardasht Region, Arak School of Nursing and Midwifery
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
zeynali287@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Zeinali
Position
MSc Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq, Sardasht Region, Arak School of Nursing and Midwifery
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
zeynali287@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared after unidentifiable of people.
When the data will become available and for how long
The beginning of the access period is 24 months after the results are published.
To whom data/document is available
All people
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
Zahra Zeinali, MSc of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran. E-mail address: zeynali287@yahoo.com
What processes are involved for a request to access data/document
After receiving the email from the requester, the information will be sent within 1 business week.
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