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The Effect of Orem’s Self-Care Model on Quality Of Life of Patients with talasemia major

Protocol summary

Summary
This study will be carry out to make the study of the Effect of Orem’s Self-Care Model on Quality Of Life of Patients with major thalassemia. Included criteria:suffering from major thalassemia ,going for blood transfusions regularely, ages between 15- 25 years. Excluded criteria: Participated in a training program at the same time and patient’s death. Researchers after finding the initial selection of samples and their satisfaction, will provide quality of life questionnaire SF-36 for them . In this study, 80 patients who were suffering from thalassemia and were eligible ,were given the questionnaires, they randomly divided into two groups,tested and control. The test groups were divided into five groups. Then a training session in lectures, questions and answers, a PowerPoint presentation, showing pictures of the pamphlet In the hall of the hospital will be held for each of the tested groups. The confrence lasts 60 minutes. At the end ,pamphlet will be placed at their disposal. Researcher once a week contact with patients by telephone in the intervention group and the questions will be answered . After 3 months of studing , quality of life questionnaire SF-36 Completed Again by the patient test and control groups. Finally, in order to observe the ethical issues of trained items to the tested group, the control group will also be trained in this issue too and pamphlet will be given to them . The primary outcome of this study is patient's quality of life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121219733N2
Registration date: 2015-05-07, 1394/02/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-07, 1394/02/17
Registrant information
Name
Mohammad Maniey
Name of organization / entity
Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4323 0999
Email address
maniey.m@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Dezful University of Medical Sciences
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2015-10-02, 1394/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Orem’s Self-Care Model on Quality Of Life of Patients with talasemia major
Public title
The Effect of Orem’s Self-Care Model on Quality Of Life of Patients with talasemia major
Purpose
Health service research
Inclusion/Exclusion criteria
Included criteria : suffering from thalassemia major; going for blood transfusion regularly; do not recive planned information about taking care of themselves; should not have active infectious disease or other restrictive; ages between15- 35 years who have had case history of hospitalization at least once;do not suffering from acute or chronic diseases such as hepatitis, heart and kidney failure, cancer, asthma and chronic obstructive pulmonary disease. Excluded criteria: Participating in a training program at the same time; Unwillingness to continue cooperation; transfer to another hospital and it cause patient’s death.
Age
From 15 years old to 35 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
Dezful University of Medical Sciences
Street address
Azadgan, Police Department, Dezful
City
Dezful
Postal code
6461653476
Approval date
2015-02-09, 1393/11/20
Ethics committee reference number
DURS-121

Health conditions studied

1

Description of health condition studied
Thalassaemia
ICD-10 code
D56.1
ICD-10 code description
Beta Thalassaemia

Primary outcomes

1

Description
Quality Of Life
Timepoint
Before Training, After 3 month Training
Method of measurement
Quality of Life Questionnaire SF36

Secondary outcomes

empty

Intervention groups

1

Description
Test group: The test group's patients will divided into five members groups separately. Then a training session in lecture, question and answer, a PowerPoint presentation, showing pictures of the pamphlet by Researcher In the hall of the hospital will be hold for each of the experimental groups. At the end of training session a pamphlet will be provided for patients will given for them and also, private counseling given to patients if it possible.
Category
Lifestyle

2

Description
Control group: This group do not receive training.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Thalassemia Ward of Dezful Major Hospital
Full name of responsible person
Roya Behmanesh
Street address
Taleghani Street, Dezful
City
Dezful

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Fereydoun Niroozad
Street address
Azadgan, Police Department
City
Dezful
Grant name
معاونت پژوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezful 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
Dezful University of Medical Sciences
Full name of responsible person
Hamide Mashalchi
Position
MSc in Nursing, faculty member of Dezful University of Medical Sciences
Other areas of specialty/work
Street address
Fatemie st, Dezful
City
Dezful
Postal code
Phone
+98 61 4242 9532
Fax
Email
mashalchih@gmail.comymadmoli@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Yaghoob Madmoli
Position
Nursing Student
Other areas of specialty/work
Street address
Martyr Khodadady alley, No 8, Masjed Soleyman
City
Masjed Soleyman
Postal code
6491853954
Phone
+98 61 4323 0999
Fax
Email
nursenanda1390@gmail.com ymadmoli@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Yaghoob Madmoli
Position
Nursing Student
Other areas of specialty/work
Street address
Martyr Khodadady Alley, No 8, Masjed Soleyman
City
Masjed Soleyman
Postal code
6491853954
Phone
+98 61 4323 0999
Fax
Email
nursenanda1390@gmail.com yaeghoobmadmoli@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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