The effect of positive thinking on the consistency and quality of life of parents of adolescents with thalassemia
Design
In this study, 52 parents of thalassemic adolescents were randomly assigned to a group of intervention and control groups by means of embedded envelope tools, and each participant was assigned a code. In the intervention group, the training is given according to the educational program and no intervention is performed in the control group. There is no phase study.
Settings and conduct
In this study, 52 parents of thalassemic adolescents in Gorgan, who are eligible to participate in the study, will be randomly selected. They will be divided into two groups of test and control and will be given positive thinking during the training sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Having at least one child with thalassemia
Exclusion criteria:
• Parents with mental and physical disabilities
• Having another patient with chronic illness that requires care and nursing.
Intervention groups
Intervention group: Education of positive thinking , behavioral and emotional changes at ten 90-minute sessions .
Control group: without any education.
Main outcome variables
Coping ;Quality of life
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20170512033932N5
Registration date:2018-09-02, 1397/06/11
Registration timing:retrospective
Last update:2018-09-02, 1397/06/11
Update count:0
Registration date
2018-09-02, 1397/06/11
Registrant information
Name
Hosein Motahariniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 4908
Email address
h_hojjati@aliabadiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of positive thinking education on adaptation and life quality in parents of teenagers with thalassemia
Public title
The effect of positive thinking education on parents of adolescents with thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have reading and writing skills
Having direct responsibility for patient care
Have at least one child of thalassemia
Exclusion criteria:
Parents do not undergo psychotherapy or counseling
Parents with mental and physical disabilities
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher provided a list of parents of thalassemic adolescents who had the conditions of the study in a simple random sampling method from those who had entered the study and randomly assigned a randomized random type according to the random allocation rule to the two experimental and control groups were divided. The randomization unit is individual. In this study, 52 parents of thalassemic adolescents were selected randomly (sealed envelopes in the envelopes were written in letters C, M) and divided into two groups: intervention and control. Each participant was assigned a code.
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 for Biological Researches at the Azad University of shahrood
Street address
Azad University Ave,Shahrood Azad University
City
Shahrood
Province
Semnan
Postal code
43189-36199
Approval date
2018-04-28, 1397/02/08
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1397.004
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
World Health Organization Quality of Life Score Score
Timepoint
Before the interventionand after intervention
Method of measurement
Based on the total score of the quality of life
Secondary outcomes
1
Description
Score of Styles of Coping Questionnaire
Timepoint
Before the intervention and after intervention
Method of measurement
Based on the total score of the overall style of the cart
Intervention groups
1
Description
Intervention group: the intervention of this study is a skill-based training in ten steps, which is described in full below: First step: understanding the concept of positive thinking and a brief familiarity with coping, optimism, and pessimism. Step two: understanding how to shape thoughts and feelings. The relationship between mind and body, the effects of positive thinking and negative thinking, and the discovery of negative thoughts. Step three: positive through challenging negative thoughts, substitution, and quarrels with negative thoughts. Step four:changing the image, subjective use of constructive thinking and revitalizing believers. Step fifth:learning the style of optimistic and cynical documents. Step six: being positive through remove tension and relaxation training. Step seven: manage feeling . Step eight: entering laughter in life and giving happiness. Step nine:attention to the present And eliminating problems and negative feelings. Step ten: summing up past discussions and providing solutions for tracking lessons.
Category
Behavior
2
Description
Control group:There was no intervention for this group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital in Gorgan
Full name of responsible person
Dr. Hamid Haghshenas
Street address
Janbazan Ave., Children Taleghani hospital
City
Gorgan
Province
Golestan
Postal code
49166 68197
Phone
+98 17 3223 4364
Email
hoseinmotahari@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ruholah Samiee
Street address
Azad Univercity Blvd
City
Aliabad katun
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
h_hojjati1362@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parna Shamsai
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Azad university Ave.
City
Ali abad katul
Province
Golestan
Postal code
4916845118
Phone
+98 17 3212 8035
Email
parnashamsai@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parna Shamsai
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Azad ave, Azad Univercity
City
Aliabad katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3223 4364
Email
parnashamsai@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamaid Hojjati
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Azad blvd.
City
Aliabad katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
h_hojjati1392@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available