Determining the Effect of Islamic Logothrapy on the Self-Recovery and Lifestyle among Mothers of Thalassemic Children
Design
Clinical trial with community-based and pragmatic control group, with parallel group design, single blind and randomized.
Settings and conduct
The research sample includes 45 mothers who will be selected non randomly based on inclusion criteria. Then they will be randomly divided into intervention and control groups.Teaching Logo therapy will be conducted during the sessions for the intervention group. The Control groupwill not be received any intervention during the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: having at least one child with thalassemia;
Willing to participate in the study;
Having at least 8 class education.
Non-Inclusion criteria: History of mental / physical illness
Intervention groups
Intervention group : Islamic spirituality will be educated for the intervention group in 8 sessions that each session will last 90 minutes. Control group: They will not receive any intervention
Main outcome variables
life style, Self-resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190127042517N1
Registration date:2019-05-08, 1398/02/18
Registration timing:retrospective
Last update:2019-05-08, 1398/02/18
Update count:0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Aman Bibi Soltani Yolme
Name of organization / entity
Islamic Azad University of Aliabad Katoul
Country
Iran (Islamic Republic of)
Phone
+98 17 3333 3962
Email address
aman_bibi_soltani@aliabadiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-11-21, 1397/08/30
Trial completion date
2019-05-20, 1398/02/30
Scientific title
The effect of Islamic logothrapy (Islamic semanticism) on the self-resilience and life-style on Mothers of thalassemia children
Public title
The effect of Islamic logic on self-resilience and lifestyle
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least one child with thalassemia
Having at least 8 class literacy
Exclusion criteria:
History of mental / physical illness (inability to attend classes)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting eligible samples, each sample will be given a number and the number will be thrown into a non-transparent envelope. The samples will be assured that numbering and placement in one of two groups will be completely random. Then, by drawing numbers from the envelope, the subjects will be randomly allocated to two groups.
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
National Ethics Committee for Chalous Unit Biological Research
Street address
Daneshgah blvd
City
Chalous
Province
Mazandaran
Postal code
3613633978
Approval date
2019-01-19, 1397/10/29
Ethics committee reference number
IR.IAU.CHALUS.REC.1397.027
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56
ICD-10 code description
Thalassemia
Primary outcomes
1
Description
Self-resiliense
Timepoint
Before and after the study
Method of measurement
Self-Alert Clock-hone Questionnaire
2
Description
life style
Timepoint
Before and after the intervention
Method of measurement
Miller & Smith Life Style Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the meetings begin, the pre-test will be taken from the intervention group. 8 training sessions will begin for 90 minutes. The sessions include: Session 1: Introducing the program, Session 2: Definitions of the meaning of life, Session 3: Reducing anxiety by finding the meaning, Session 4: Self-knowledge of meaningful sources, Session 5: Finding the meaning from the past, Session 6: Overcoming Despair, Session 7: Para meaning and Session 8: Finding the meaning. Upon completion of the training, the post-test will be taken from intervention group.
Category
Lifestyle
2
Description
Control group: Before the meetings begin, the pre-test will be taken from the control group.control group will not be received the Interventin.After the end of the intervention, the post test will be taken.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Children's Hospital
Full name of responsible person
Aman Bibi Soltani Yolme
Street address
East Taleghani
City
Gonbad-e Qabus
Province
Golestan
Postal code
4971169183
Phone
+98 17 3333 3962
Email
ailarsoltani1361@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rouhollah Samii
Street address
Daneshgah blvd
City
Ali abad catul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Fax
+98 17 3422 5673
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, Ali Abad Katoul Branch
Full name of responsible person
Aman bibi soltani yolme
Position
Masters
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University Bluff - Islamic Azad University, Ali Abad Katoul Branch
City
Ali Abad Katoul
Province
Golestan
Postal code
49417-93451
Phone
+98 17 3422 2300
Email
ailarsoltani1361@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Aman bibi soltani yolme
Position
Masters of Pediatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Eastern Thaleghani
City
Gonbad-e Qabus
Province
Golestan
Postal code
4971169183
Phone
+98 17 3333 3962
Email
ailarsoltani1361@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Aman Bibi Soltani Yolme
Position
Masters of Pediatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
East Taleghani
City
Gonbad-e Qabus
Province
Golestan
Postal code
4941793451
Phone
+98 17 3333 3962
Email
ailarsoltani1361@gmail.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