Protocol summary

Summary
The aim of this study was to Application of biological aspect of Roy’s Adaptation Model to Promote Psychosocial Status of Patients With Cerebrovascular accident. Participation in care plan by the doctors ; awareness of time, place, and individuals ; absence of visual and hearing problem, of musculoskeletal disorders that prevent fulfillment of care plan, experiencing CVA for the first time ; tendency, motivation and ability to receive training and execute care plan. Exclusion criteria: Disinclination of the patients to continue care plan and absence for minimal two sessions during the study was considered as exclusion criteria. In this clinical trial, 50 CVA patients through accessibility sampling were selected from hospitals of Isfahan during 2014-2015 and randomly assigned to two groups of similar size. The data was collected through researchers’ developed form of recognition and review of Roy’s model. The care plan was developed based on the maladaptation behaviors and their stimuli which were implemented in the intervention group and follow-up study was also done. The control group received routine cares. The effect of program based on Roy model in psychosocial level of adaptation in stroke patients were studied.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015061618339N2
Registration date: 2015-10-13, 1394/07/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-13, 1394/07/21
Registrant information
Name
Nasrollah Alimahammadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2918
Email address
alimohammadi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-12-02, 1392/09/11
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Application of Roy’s Adaptation Model to Promote Psychosocial Status of Patients with CVA
Public title
Roy Adaptation Model
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Participation in care plan by the doctors ; awareness of time, place, and individuals ; absence of visual and hearing problem, of musculoskeletal disorders that prevent fulfillment of care plan, experiencing CVA for the first time ; tendency, motivation and ability to receive training and execute care plan Exclusion criteria: Disinclination of the patients to continue care plan and absence for minimal two sessions during the study was considered as exclusion criteria
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethics Committee of the Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences , Street Hezarjarib
City
Isfahan
Postal code
8174673461
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
د/11/3473

Health conditions studied

1

Description of health condition studied
Brain Stroke
ICD-10 code
I69.4
ICD-10 code description
Sequelae of stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
Psychosocial Status
Timepoint
Before Intervention and 2 Months afterIntervention
Method of measurement
Adaptationl Questionnaire

Secondary outcomes

1

Description
Adaptation Level
Timepoint
Preintervention and 2 months after Intervention
Method of measurement
Adaptation Level Questionnaire

Intervention groups

1

Description
"Control Group:One Educational Session"
Category
Rehabilitation

2

Description
"Intervention Group:The training program based on the Roy adaptation model of the four sessions of 90-60 minutes and one month follow-up
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Al Zahra Hospital
Full name of responsible person
Doctor Nasrollah Alimohammadi
Street address
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Doctor Mehdi Nematbakhsh
Street address
Vice Chancellor for Research of Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Doctor Nasrollah Alimohammadi
Position
Nursing phd, Vice-Chancellery for Education,Nursing and midwifery faculty
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, University of Medical Sciences ,Hezarjar Street b
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2918
Fax
+98 31 3669 9398
Email
alimahammadi@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Doctor Nasrollah Alimohammadi
Position
Nursing PhD
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, Isfahan University of Medical Sciences, Hezarjrib Street
City
Isfahan
Postal code
Phone
+98 34 3792 2950
Fax
Email
alimahammadi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Doctor Nasrollah Alimohammadi
Position
Nursing PhD
Other areas of specialty/work
Street address
Nursing and Midwifery faculty,Isfahan University of Medical Sciences,Hezarjerib Street
City
Isfahan
Postal code
Phone
+98 31 3792 7516
Fax
Email
alimohammadi@nm.mui.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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