Objective: to determine the effect of individual psychotherapy based on self-efficacy on quality of life of patients with major thalassemia. Major inclusion criteria include Patients with major thalassemia; Lack of experience the severe stressful events in the past year; Able to read and write Persian language and age above of 15 years old. Major exclusion criteria including experience the severe stressful events during the study; death; unwillingness to continue this research (patient or family) and exacerbation of disease. Design of study: randomized, Population: patients with major thalassemia. Sample size: 50 patients. Intervention: After random allocation of patients to intervention and control groups, individual psychotherapy based on self-efficacy use as intervention for patients in the intervention group. The sessions will be in 8 weeks and every week a session lasted 45 minutes. In these training sessions, the researcher teaches the intervention group about approaches for identifies anxiety, coping with stress, interpersonal coping, methods for controlling anxiety, and optimism. In control group don`t perform any intervention. The time and primary outcomes: changing in quality of life and self-efficacy evaluated with quality of life questionnaire and Sherer self-efficacy questionnaire in admission and 1 month after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041627425N1
Registration date:2016-05-21, 1395/03/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Parigol Taheri
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 742 6223
Email address
parigol.taheri@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research & technology,Yasuj University of Medical Sciences
Expected recruitment start date
2016-06-14, 1395/03/25
Expected recruitment end date
2017-01-14, 1395/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of individual psychotherapy based on self-efficacy on quality of life of patients with major thalassemia
Public title
Effect of individual psychotherapy based on self-efficacy on quality of life of patients with major thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria include Patients with major thalassemia according to physician`s diagnosis; Lack of experience the severe stressful events such as death, illness, accident and divorce in the past year; Lack of a history about debilitating physical illnesses, severe mental disability and mental illness based on patient records and physician`s diagnosis. Able to read and write Persian language and age above of 15 years old. Exclusion criteria including experience the severe stressful events during the study such as debilitating physical illnesses, severe mental disability and mental illness, severe physical injuries such as fractures; death; unwillingness to continue this research (patient or family) and exacerbation of disease.
Age
No age limit
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yasuj University of Medic Sciences
Street address
Yasuj,Yasuj University of Medical Sciences
City
Gachsaran
Postal code
Iran
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
ir.yums.REC.1395.1
Health conditions studied
1
Description of health condition studied
Major Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Quality of life
Timepoint
In admission and then 1 month after admission
Method of measurement
Quality of life questionnaire(SF-36)
Secondary outcomes
1
Description
Self efficacy
Timepoint
In admission and then 1 month ago
Method of measurement
Sherer Self Efficacy Questionnaire
Intervention groups
1
Description
In this study, the individual psychotherapy based on self-efficacy session used as an intervention in the intervention group. The sessions will be in 8 weeks and every week a session lasted 45 minutes.In these training sessions, the researcher teaches the intervention group about approaches for identifies anxiety, coping with stress, interpersonal coping, methods for controlling anxiety, and optimism.
Category
Lifestyle
2
Description
In the control group is not done any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Parigol Taheri
Street address
Gachsaran, Shahid Rajaee Hospital
City
Gachsaran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Kheyrollah Noryan
Street address
Yasuj, Yasuj University of Medical Sciences
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Parigol Taheri
Position
Student of Psychological Nursing
Other areas of specialty/work
Street address
Yasuj, Faculty of Nursing and Midwifery
City
Gachsaran
Postal code
Phone
+98 74 3222 2704
Fax
Email
ptaheri10@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Kheyrollah Noryan
Position
PhD, Dean of faculty
Other areas of specialty/work
Street address
Kohgiloyeh and Boyer Ahmad, Yasuj University of Medical Sciences
City
Yasuj
Postal code
Phone
+98 74 3334 6078
Fax
Email
khnoryan@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Parigol Taheri
Position
Student of Psychiatric Nursing
Other areas of specialty/work
Street address
Gachsaran, Shahid Rajaii Hospital
City
Gachsaran
Postal code
7581993111
Phone
+98 74 3222 2704
Fax
+98 32 2222 2265
Email
ptaheri10@gmail.coms.mazaherpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)