Protocol summary

Summary
This a clinical trial study to examine the effect of life skills training on family function of mothers with Major Thalassemia children. Interventions were done in the Beheshti Hospital of Yasuj in winter 2016. Samples were included 70 mothers with Major Thalassemia children who randomly divided in 2 groups of experimental and control (each group 35 persons). The aim of study was explained and both groups filled out McMaster Family Assessment Device then experimental group took part in life skills related to family function training sessions for 7 weeks and once a week. Sessions were held as a speech about 60-90 minutes. Assessment tool, McMaster Family Assessment Device, before and 1 month after interventions was completed by both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121525531N1
Registration date: 2016-07-30, 1395/05/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
Maryam Khanali
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5141
Email address
maryam.khanali@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Yasuj University of Medical Sciences , Research and Technology
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of life skills training on family function of mothers with Major Thalassemia children
Public title
the effect of life skills training on family function of mothers with Major Thalassemia children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Tendency to participate in the study, maximum age 45 year old, ability to write and read, having a children with Major Thalassemia which is confirmed by hematologist, at least 1 year has been passed from treatment, children with Thalassemia live with their family, children have no psychological disease like mental retardation and Cognitive behavioral disorder that proved by psychologist. Exclusion criteria: No tendency to continue attendance, immigration,Hospitalization of children with Major Thalassemia
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
After selecting samples they allocated in tow groups based on 2 group block randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical sciences
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science,Blvd Martyr Motahary, Yasuj, Iran Yasuj
City
Yasuj
Postal code
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
Ir.yums.rec.1394.105

Health conditions studied

1

Description of health condition studied
Major Thalassemia
ICD-10 code
o00-o99
ICD-10 code description
congenital malformations, deformations and chromosomal abnormalities

Primary outcomes

1

Description
family function
Timepoint
before intervention and 1 month after intervention.
Method of measurement
McMaster Family Assessment Device

Secondary outcomes

empty

Intervention groups

1

Description
1st group or intervention group, were trained for life skills related to family function. Sessions were held as a speech about 60-90 minutes, once a week for 7 weeks.
Category
Other

2

Description
no intervention for control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Hospital of Yasouj
Full name of responsible person
Doctor Mehdi Akbartabar turi
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science,Blvd Martyr Motahary, Yasuj, Iran Yasuj
City
Yasouj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasuj University of Medical sciences
Full name of responsible person
Doctor Mehdi Akbartabar turi
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science,Blvd Martyr Motahary, Yasuj, Iran
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Yasuj University of Medical sciences
Full name of responsible person
Dr.Ali Karam Alamdari
Position
PHD of training in health research
Other areas of specialty/work
Street address
Nursing and Midwifery College, St. Martyr Dr. Jalil, Yasuj, Iran Yasuj
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
akalamdari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical sciences
Full name of responsible person
Dr.Ali Karam Alamdari
Position
PHD of training in health research
Other areas of specialty/work
Street address
Nursing and Midwifery College, St. Martyr Dr. Jalil, Yasuj, Iran Yasuj
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
akalamdari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical sciences
Full name of responsible person
Mmaryam Khanali
Position
MS student of community health nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, St. Martyr Dr. Jalil, Yasuj, Iran Yasuj
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
Maryam.khanali@yums.ac.irMaryam.khanali@yahoo.com
Web page address

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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