The study aimed to determine the effect of counseling on the quality of life in patients with major thalassemia with random allocation to treatment or control groups with Inclusion criteria: patients with a minimum age of 12 years suffering from thalassemia major in thalassemia treatment center in Bushehr with medical records and the ability to complete the questionnaire and also have a desire to participate in the study, Exclusion criteria: disease or other chronic ailments in addition to the psychological profile of patients with thalassemia،Lack of sample firms in more than two sessions of group therapy counseling. The total sample size of 62 individuals and group counseling intervention for intervention by a clinical psychologist within 6 weeks (2 sessions per week) (intervention group consists of three sub-group each 4 sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070328750N1
Registration date:2016-07-16, 1395/04/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-16, 1395/04/26
Registrant information
Name
Rezvan Bakhshi
Name of organization / entity
Bushehr University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 77 3422 9797
Email address
r.bakhshi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research, Bushehr University of Medical Sciences
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling on the quality of life in patients with major thalassemia referred to thalassemia treatment center in Bushehr in 2016
Public title
The effect of counseling on the quality of life in patients with major thalassemia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: patients with a minimum age of 12 years old suffering from thalassemia major in thalassemia treatment center in Bushehr, Iran with medical records and the ability to complete the questionnaire and also have a desire to participate in the study. Exclusion criteria: the psychological profile of the treated disease or other chronic disease thalassemia in addition to the obstacle of the samples used in the study. Lack of sample firms in more than two sessions of group therapy counseling.
Age
From 12 years old to 46 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
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
Bushehr University of Medical Sciences
Street address
Bushehr,Rishehr,next to Salman Farsi Hospital
City
Bushehr
Postal code
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.BPUMS.REC.1395.51
Health conditions studied
1
Description of health condition studied
Major thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Quality of life
Timepoint
Before intervention and one month after intervention
Method of measurement
SF- 36 quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Programs psychological counseling group in which the intervention group (n = 31) into three groups (two subgroups of 10, a group of 11 people) is divided and for each subgroup 4 sessions of 60-90 minutes two sessions per week, total 12 sessions for 6 weeks conducted by a clinical psychologist with a cognitive behavioral approach.
Category
Behavior
2
Description
No intervention in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia treatment Center in Bushehr
Full name of responsible person
Mrs. Bashi
Street address
Thalassemia treatment center in Bushehr
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research, Bushehr University of Medical Sciences
Full name of responsible person
Dr. Afshin Ostovar
Street address
Bushehr University of Medical Sciences, Salman Farsi Street, Bahmani St.
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research, Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Sherafat Akabarian
Position
Master of nursing,science Committee
Other areas of specialty/work
Street address
Nursing Faculty, Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 3455 0187
Fax
Email
sh.akabarian@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Masoud Bahreini
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Faculty, Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 3345 0187
Fax
Email
msdbahreini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Sherafat Akabarian
Position
Master of nursing,science Committee
Other areas of specialty/work
Street address
Nursing Faculty, Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 3455 0187
Fax
Email
sh.akabarian@bpums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)