Protocol summary

Summary
Aim: The aim of this study was to assess the effect of training on social adjustment in mothers of educable mentally retarded children based on Roy adaptation theory. Method: The study was a quasi experimental with single group in pre and post test plan. The study population was included 40 mothers of educable mentally retarded children that referred to Aran & Bidgol School (2010-2011) that selected according to chance. Inclusion criteria: have least one mental retarded child in school; haven't mental disease and have literacy. Exclusion criteria: haven't satisfaction for research continuing and haven't presence in training class more than 2 session. Intervention performed in 4 training sessions on single group of research. Each session included 2 hours lecture and 30 minutes question and response in 2 weeks. Training content applied training of adaptation based on Roy adaptation theory dimension (physiologic, self concept, dependence and independence, role playing). Adaptation scale completed by mothers initially and at the end of 6th week of intervention. The effect of training measured by comparison of pre and post of intervention.

General information

Acronym
Social adjustment
IRCT registration information
IRCT registration number: IRCT201107287139N1
Registration date: 2012-02-11, 1390/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-11, 1390/11/22
Registrant information
Name
Zahra Aliakbarzade Arani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 2276 3567
Email address
aliakbarzade_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-02-04, 1388/11/15
Expected recruitment end date
2010-04-04, 1389/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of training on social adjustment in mothers of educable mentally retarded children based on Roy adaptation theory
Public title
Adjustment in mothers of educable mentally retarded children
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: have least one mental retarded child in school; haven't mental disease and have literacy. Exclusion criteria: haven't satisfaction for research continuing and haven't presence in training class more than 2 session.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Sort 6, University Central Organization, Ghods Street, Keshavarz Boulevard,Tehran
City
Tehran
Postal code
Approval date
2011-08-14, 1390/05/23
Ethics committee reference number
812/130/د/90

Health conditions studied

1

Description of health condition studied
Social adjustment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Social adjustment
Timepoint
previous and 6 weeks post of intervation
Method of measurement
Scale

Secondary outcomes

empty

Intervention groups

1

Description
Training
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Aran and Bidgol Omid school
Full name of responsible person
Street address
Amirkabir street, Azadegan square
City
Aran and d Bidgol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Reza Negarande
Street address
Nursing & midwifery faculty of Tehran University of Medical Sciences
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
University of Medical Sciences
Full name of responsible person
Zahra Aliakbarzade Arani
Position
Nursing Msc
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, University of Medical Sciences, Ravandi Ghotb Boulevard,Kashan
City
Kashan
Postal code
87159-81151
Phone
+98 36 2276 3567
Fax
+98 36 1555 6633
Email
aliakbarzade_z@kaums.ac.ir/nursing_aran@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Zahra Aliakbarzade Arani
Position
Nursing Msc
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, University of Medical Sciences, Ravandi Ghotb Boulevard, Kashan
City
Kashan
Postal code
87159-81151
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
aliakbarzade_z@kaums.ac.ir/nursing_aran@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Zahra Aliakbarzade Arani
Position
Nursing Msc
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, University of Medical Sciences, Ravandi Ghotb Boulevard, Kashan
City
Kashan
Postal code
87159-81151
Phone
+98 36 2276 3567
Fax
+98 36 1555 6633
Email
aliakbarzade_z@kaums.ac.ir
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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