Protocol summary

Summary
It is quasi-experimental study. The aim of this study was to determine the effect of family centered empowerment program on self-efficacy in adolescents with thalassemia major. The research environment is specific diseases Aboureihan center in Bandar Abbas. Teens (12-18 years) with thalassemia major and active members of their family, community, and in this study, samples are adolescents with thalassemia major aged (12-18) years with a family member who Are eligible. Sampling available. The control group had 35 people that will be removed from the intervention group. Tools put at the control group and without intervention, tools again after 1.5 months they will be completed. 35 patients in the intervention group selected that will have the inclusion criteria. After confirming the validity content of teaching, Intervention as a family-centered empowerment programs in four structures of knowledge, self-efficacy, training participation and evaluation will be conducted. Inclusion criteria included: A partnership a family member with patient, have at least read and write to the patient and Active member of the family and Ability to participate in the program. Exclusion criteria included: Unwillingness of the patient and an active member of family to participate in the study and Unwillingness of the patient and an active member of family to participate in Problem solving and training sessions. It's expected that this program to be one of the nursing interventions used to increase the efficacy in patients with thalassemia major.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201407211788N8
Registration date: 2015-06-01, 1394/03/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-01, 1394/03/11
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences,research vice chancellor
Expected recruitment start date
2014-03-30, 1393/01/10
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family- centered empowerment program on self-efficacy in adolescents with thalassemia major
Public title
The effect of family centered empowerment program on self-efficacy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria included: • A partnership a family member with patient • have at least read and write to the patient and Active member of the family • Having Medical records in center • Lack of specific mental health problem • Ability to participate in the program Exclusion criteria included: • Unwillingness of the patient and an active member of family to participate in the study. • Unwillingness of the patient and an active member of family to participate in Problem solving and training sessions.
Age
From 81 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Qods St., Central University
City
Tehran
Postal code
Approval date
2014-01-14, 1392/10/24
Ethics committee reference number
92/د/130/2376

Health conditions studied

1

Description of health condition studied
Beta Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Cooley anaemiaSevere beta thalassaemia Thalassaemia:•intermedia

Primary outcomes

1

Description
general self- efficacy
Timepoint
Before the intervention, after the intervention
Method of measurement
Schwarzer General Self-Efficacy Scale( GSE-10)

2

Description
Disease-related self-efficacy
Timepoint
Before the intervention, after the intervention
Method of measurement
Sickle Cell Self-Efficacy Scale(SCSES)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: these people are selected from specific diseases Aboureihan center in Bandar Abbas. We give them the tools to complete their And 1.5 months later, without any intervention so that only routine nursing care received, the tools will be completed.
Category
Other

2

Description
Intervention Group: Sampling available. these people are selected from specific diseases Aboureihan center in Bandar Abbas. After obtaining the written consent of the subjects in the experimental group, pre-test will be conducted. Empowering patients based on four constructs: knowledge, self-efficacy, training participation and evaluation. The first step (perceived threat) empowerment program will try to increase their knowledge through booklets and group discussion. Thus, based on the number of teenagers, they were divided into groups of 3-5 people. Empowerment programs to suit the needs of the participants every two weeks, three sessions, 30-45 minutes. At this stage, Participants were asked to transfer educational materials that have learned to bring a family member. Therefore, educational pamphlets given to them To be an active member of family. That study and questions that come to mind, write in a sheet and the next meeting, deliver researcher. Therefore, the next meeting will review all comments. . During the second step (self-efficacy), aims to improve patients' self-efficacy through group discussion and collaborative problem solving. In the third step (educational participation), will try to increase the efficacy through educational participation. . As mentioned in the first step, Participants were asked to Information obtained from meetings and educational pamphlets, available to active members of their family. So to ensure we achieve this goal, the participants requested that with active member be present at the meeting and participate in group discussions and question and answer. The fourth step is evaluation done in two stages. The first stage involve asking two questions orally at the beginning of each session and The second stage is the final evaluation that instruments will be completed again by the sample.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The specific diseases Aboureihan center
Full name of responsible person
belgheis Sheibani
Street address
Bandar Abbas. koi shafa-The specific diseases Aboureihan center
City
Bandar Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Yunesian
Street address
Ghods Street, Tehran, Keshavarz Boulevard, Central Building
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
ran University of Medical Sciences
Full name of responsible person
Leili Borimnejad
Position
PHD/ Assistant Training
Other areas of specialty/work
Street address
Vali Asr (AS) –Higher from Vanak Square - Rashid Street Yasami Faculty of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21
Fax
Email
l.borimnejad@gmail.com
Web page address
www.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leili borimnejad
Position
PHD
Other areas of specialty/work
Street address
Vali Asr (AS) –Higher from Vanak Square - Rashid Street Yasami Faculty of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21
Fax
Email
l.borimnejad@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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