Background: Patients with thalassemia are faced with several phrsiological and psychologiacal problems such as disruption in physical activity,social life and school performance ,that causes lower adaptation levels in these patients. The purpose of this study was to determine the effect of education based on Roy adaptation model on the level of physiological and psychologic adaptation in thalassemic patients in Zahedan Ali-Asghar hospital in 2016.
Methods: In this semi-experimental study, two groups with pre-test and post-test design, 80 patients with major thalassemia in Ali-Asghar hospital in Zahedan will be recruited to the study in 2016. They will be randomly assigned in intervention and control group based on week. Before the intervention, Roy adaptation questionnaire and demographic data will be completed in both intervention and control groups. Then the intervention group will train based on Roy adaptation model and the control group will receive only routine care.two mounth after completion of the training sessions, the questionnaire will be completed in both groups. SPSS software version 22 will be used to analyze the data using independent T-test, paird T-test and chi-square test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071234925N2
Registration date:2017-09-22, 1396/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
Sakineh Ghaderi
Name of organization / entity
Zahedan University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 56 3240 7212
Email address
fatemeh.chagi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciense
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care plan based on Roy Adaptation Model on physiological and psychological adaptation in patient with thalassemia major
Public title
Effect of Roy Adaptation Model on adaptation levels of Thalassemic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age up to 18; having thalassemia diagnosis;having minimum education; dont have any physiologic or mental disease; dont have drug abuse; dont have any hearing or sight problems; to understand farsi language; having good situation
Exclusion criteria:dont participate in one class; having an acute or vital situation
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Zahedan University of Medical Science
Street address
Mashahir square, Nursing faculty
City
Zahedan
Postal code
9816743463
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
ir.zaums.rec.1395.132
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D63
ICD-10 code description
anemia in chronic disease classified in elsewhere
Primary outcomes
1
Description
Adaptation
Timepoint
Before and 2 mounth after intervention
Method of measurement
Researcher made Roy Adaptation questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group: Face to face education in 5 sixty minutes sesions
Category
Other
2
Description
In control group: Just routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Doctor Ali Navidian
Street address
Nursing Faculty, Mashahir Squaire
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Doctor Fariba Yaghoubimia
Street address
Nursing Faculty, Mashahir Squaire
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Science
Full name of responsible person
Fatemeh Soghra Chaji
Position
Nursing Master Student
Other areas of specialty/work
Street address
Nursing Faculty, Mashahir Squaire
City
Zahedan
Postal code
9716843463
Phone
+98 54 3329 5765
Fax
+98 33295765
Email
fatemehchaji@yahoo.com
Web page address
www.zaums.ic.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Fatemeh Soghra Chaji
Position
Master Nursing Student
Other areas of specialty/work
Street address
Nursing Faculty, Mashahir Squaire
City
Zahedan
Postal code
9816743463
Phone
+98 54 3329 5765
Fax
+98 33295765
Email
fatemehchaji@yahoo.com
Web page address
www.zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Fatemeh Soghra Chaji
Position
Master Nursing Student
Other areas of specialty/work
Street address
Nursing Faculty, Mashahir Squaire
City
Zahedan
Postal code
9816743463
Phone
+98 54 3329 5765
Fax
+98 33295765
Email
fatemehchaji@yahoo.com
Web page address
www.zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)