Protocol summary

Study aim
Determining the Effect of Zinc System Model on Social Adjustment and Resilience of Mothers of Thalassemic Children
Design
The sample size was 25 people and were randomly selected and divided into two experimental and control groups
Settings and conduct
The place of study was Taleghani Hospital of Gonbad Department of Thalassemia which was done in eight training sessions for the experimental group. Before and after the study, both groups completed the questionnaires.
Participants/Inclusion and exclusion criteria
Entry requirements: have a thalassemia child and consent to participate in the study. Conditions of non-entry: Dissatisfaction for participation in the study.
Intervention groups
Training class and use of CD and player from computer
Main outcome variables
Resiliency; Social adjustment; Thalassemia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190415043285N1
Registration date: 2019-05-08, 1398/02/18
Registration timing: registered_while_recruiting

Last update: 2019-05-08, 1398/02/18
Update count: 0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
zeinab rashki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3422 2300
Email address
z_rashki@aliabadiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-04, 1397/02/14
Expected recruitment end date
2018-06-04, 1397/03/14
Actual recruitment start date
2019-05-04, 1398/02/14
Actual recruitment end date
2019-06-17, 1398/03/27
Trial completion date
2019-06-17, 1398/03/27
Scientific title
The effect of Roy adaptation model on the social adaptation and resilience of mothers of thalassemic children 7-19 years old in Gonbad city
Public title
Social adaptation and resilience of mothers of thalassemic
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least one thalassemia child The desire to participate in research Not having physical and psychological problems
Exclusion criteria:
Not attending two sessions of 8 sessions Non-cooperation Stir the meetings
Age
From 7 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
Actual sample size reached: 26
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method was available from among those who were admitted to the study and randomly divided into two groups of test and control.
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 Islamic Azad University, Shahroud Branch
Street address
Shahroud Azad University
City
shahrood
Province
Semnan
Postal code
43189-36199
Approval date
2019-03-13, 1397/12/22
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1397.039

Health conditions studied

1

Description of health condition studied
Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism(D50-D89)

Primary outcomes

1

Description
The compatibility score obtained from the Bell Compliance Inventory
Timepoint
Before and after intervention
Method of measurement
Bell compatibility questionnaire

2

Description
A resonance score derived from the Conor Davidson questionnaire
Timepoint
Before and after intervention
Method of measurement
Conor David Sohn Resilience Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Eight training sessions and presentation of pamphlets and educational CDs.The first session involves getting acquainted with the researcher and the mothers together and completing the questionnaires. The second meeting was an explanation of the incidence of thalassemia, its prevalence in Iran, the importance of family role in protecting patients, the impact of thalassemia on the family and ways to prevent it.The third session was given to mothers in relation to physiological needs such as nutrition, sleep, evolutionary needs, and the absorption and disposal of information. The fourth session was dedicated to the aspect of self-concept, which was discussed at the meeting about the importance of the mother's mental imagery, the reality of life, and the concept of self-concept and happy life.The fifth session of the role play and help to improve the roles: motherhood, fraternity, husbandry and social roles, and in the sixth session, in relation to the dimension of attachment, understanding and control of negative feelings and emotions, and reducing the positive feelings toward the problem Your child was held in a group. The seventh session was also conducted individually and individually. After the end of the sessions (eighth session), the posttest was provided to both groups and completed with the help of the researcher.
Category
Behavior

2

Description
Control group: There is no special training
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Behzad Pachenari
Street address
Taleghani street
City
Gonbad
Province
Golestan
Postal code
4979155993
Phone
+98 17 3328 6920
Email
z_rashki@aliabadiau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hojati Hamid
Street address
Ayat street
City
Aliabad
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 2300
Fax
+98 17 3422 4500
Email
h_hojjati1362@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
100
Public or private sector
Private
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
Zeinab Rashki
Position
master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
ayat street
City
aliabad
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
z_rashki@aliabadiau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hojati
Position
Nursing Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ayat street
City
Aliabad
Province
Golestan
Postal code
49417-93451
Phone
+98 17 3422 4500
Email
h_hojjati1362@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hojati
Position
Nursing Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ayat street
City
Aliabad
Province
Golestan
Postal code
49417-93451
Phone
+98 17 3422 4500
Email
h_hojjati1362@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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
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