Background: Amputation in veterans have been affected several aspects of their lives. According to the importance of adaptation and coping in chronic disease management, the present study was designed to determine the effectiveness of care plan based on “Roy’s adaptation model” on coping strategies of war veterans with lower limb amputees.
Material and Method: This study is clinical trial and was performed in Kosar Orthotics and Prosthetics Center in Tehran in 2013- 2014. Lower limb amputee veterans using convenience sampling method were recruited and were allocated randomly into experimental and control groups. The research instruments included the demographic questionnaire, the Roy Adaptation Questionnaire and the coping strategies questionnaire of Lazarus and Folkman. Face and content validity of Roy’s Adaptation Questionnaire was evaluated with content validity index and ratio. The reliability of questionnaire also was examined and approved. Questionnaires completed by the subjects in the pre-test phase and the care plan based on the Roy’s Adaptation Model in the experimental group were designed and conducted. Then, two months after, the questionnaires were completed by both groups. The data were analyzed by descriptive and analytic statistics and by SPSS 19 version with p<0/05 significance level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081118763N1
Registration date:2014-09-26, 1393/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-26, 1393/07/04
Registrant information
Name
Somayeh Azarmi
Name of organization / entity
AJA University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7750 0201
Email address
s.azarmi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
AJA University of Medical Science
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care plan based on “Roy’s adaptation model” on coping strategies of war veterans with lower limb amputees
Public title
The effect of “Roy’s adaptation model” on coping strategies
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The ability of reading and writing, age below 65 years, not having a known mental illness, lack of spinal cord injury, not be Chemical veterans.
Exclusion Criteria: Unwillingness to pursuit of the study process.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
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
AJA University of Medical Science
Street address
The next of Emam Reza hospital, Tehran
City
Tehran
Postal code
18151-16139
Approval date
2013-06-20, 1392/03/30
Ethics committee reference number
9203
Health conditions studied
1
Description of health condition studied
Lower limb amputee
ICD-10 code
T93.6
ICD-10 code description
Sequelae of crushing injury and traumatic amputation of lower limb
Primary outcomes
1
Description
Coping Strategies
Timepoint
befor of intervention- two months after of intervention
Method of measurement
Standard questionnaire
Secondary outcomes
1
Description
Adaptation
Timepoint
Befor of intervention- two months after of intervention
Method of measurement
Questionnair that is made by researcher
Intervention groups
1
Description
In experimental group: Intervention included care plan and education of adaptation strategies based on Roy’s Adaptation Model in four dimensions at two sessions with two- hour in two week with 30 minute Question and respond at the end of sessions. Also, training manual Contains a summary of the training were given to subjects. Telephone follow-up was conducted over 2 months.
Category
Rehabilitation
2
Description
In control group: Without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Orthotics and Prosthetics Center
Full name of responsible person
Mr Kabiri
Street address
Edge of Boostane Dahom, Banyhashem Street, Resalat Highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AJA University of Medical Science
Full name of responsible person
Mrs Heiranipour
Street address
The next of Emam Reza hospital, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA University of Medical Science
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
AJA University of Medical Science
Full name of responsible person
Somayeh Azarmi
Position
MSc
Other areas of specialty/work
Street address
Shareati Street, Faculty of Nursing, AJA University of Medical Sciences, Tehran