Protocol summary

Study aim
Determination the effect of self-caring using tele-Nursing on teenagers self-efficacy suffered from major Thalassemia.
Design
In the present study 30 major thalassemia teenagers having proper condition for participating in the research and went to Shahid-Dast Gheyb hospital of Shiraz are selected. Sampling method considering classifying were divided to two groups randomly , but considering samples selection, is non-random and target-based and a code were given to each participants.
Settings and conduct
This survey will be conducted semi-experimental intervention in Dast-Gheyb hospital, which is center of children admitting in the province. Which in intervention group, self-caring teaching is performed in six Telegram contact during 8 weeks with subjects including: nutrition, sport and stress management using tele-Nursing method in major thalassemia teenagers. Teenagers Self-efficacy questionnaires (SEQ-C) was used in both groups before and after intervention.
Participants/Inclusion and exclusion criteria
Indices for entering and exiting research include: tending to participate in the study and telephone teaching, having active file records in thalassemia section of the hospital, having cell phone personally or in family or having ability for installing Telegram application.
Intervention groups
In the present study, the self-caring include: proper nutrition and sport and physical education and stress management and practice of practical methods of overcoming stress using tele-nursing method through 6 telegram contact during 8 weeks in intervention group will be performed , and control group just received routine teaching of thalassemia section
Main outcome variables
In the present study self-caring were measured, using tele-nursing( independent variable) and self-efficacy level in thalassemia teenagers ( dependent variable).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170826035907N1
Registration date: 2018-01-01, 1396/10/11
Registration timing: retrospective

Last update: 2018-01-01, 1396/10/11
Update count: 0
Registration date
2018-01-01, 1396/10/11
Registrant information
Name
Tahereh Tarakmeh
Name of organization / entity
The Islamic Azad University, Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
+98 22006660
Email address
lamhamuz2@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Tehran Medical Branch
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining effect of self-caring using Tele-Nursing on major thalassemia teenagers self-efficacy
Public title
The effect of self-caring using Tele-Nursing on thalassemia teenagers self-efficacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Indices for entering and exiting research include: tending to participate in the study and telephone teaching Having active file records in thalassemia section of the hospital Lack of serious disorder in parents and another family members Having cell phone personally or in family or having ability for installing Telegram application. Lack of behavioral, mental, hearing and speech disorders according to the medical records and lack of another same as diabetic and cardiac disease Teenager disease lasting more than a year
Exclusion criteria:
Age
From 13 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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 on Research in Islamic Azad University, Tehran Medical Branch
Street address
Islamic Azad University, Tehran Medical Sciences Branch, Khaghani St, Shariati St, Tehran.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2017-07-26, 1396/05/04
Ethics committee reference number
IR.IAU.TMU.REC.1396.104

Health conditions studied

1

Description of health condition studied
Thalassemia in adolescents
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia

Primary outcomes

1

Description
Efficacy
Timepoint
Before intervention, three months after the intervention
Method of measurement
Children and teenagers Self-efficacy Scale (SEQ-C)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in this group, self-caring teaching using tele-nursing through telegram in form of contacting 6 telegram call during 8 weeks.
Category
Lifestyle

2

Description
Control group: in this group just routine teaching were received.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital in Shiraz
Full name of responsible person
Tahereh Tarakmeh
Street address
Hafez Street, Shiraz
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3627 1530
Email
lamhamuz2@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Alaee Kerahroodi
Street address
Islamic Azad University, Tehran Medical Sciences Branch, Khaghani St., Shariati St., Tehran.
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 21 2260 1934
Email
research@iautmu.ac.ir
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
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
Islamic Azad University
Full name of responsible person
Tahereh Tarakmeh
Position
Senior Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Tehran Medical Sciences Branch, Khaghani St., Shariati St., Tehran.
City
Tehran
Province
Fars
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
Email
lamhamuz2@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Alaee Kerahroodi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Tehran Medical Sciences Branch, Khaghani St., Shariati St., Tehran.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
Email
Falaee@iautmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahereh Tarakmeh
Position
MSc Student in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The Islamic Azad University, Tehran Medical Branch, Khaghani St., Shariati St., Tehran.
City
Tehran
Province
Fars
Postal code
1916893813
Phone
+98 21722006660
Fax
Email
lamhamuz2@sums.ac.ir
Web page address

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
I do not plan to publish it.
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
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Delivering Ethic forms to patients and completing them
When the data will become available and for how long
After completing the project
To whom data/document is available
patient
Under which criteria data/document could be used
Notice the result of the project
From where data/document is obtainable
Research Deputy
What processes are involved for a request to access data/document
Request by patient to the research deputy via letter
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