Determining The effect of FRIENDS educational program on resilience and health related quality of life of adolescents with hemophilia
Design
Clinical trial with control group, with single, randomized groups, 60 patients
Settings and conduct
Approval of the research plan in the university ethics committee. At the beginning of the study, complete the demographic characteristics checklist, the Liebenberg and Ungar's Child and Youth Resilience Measure-28 item and Health Related Quality of Life Questionnaire "KIDSCREEN-27 item. In the intervention group, The participants will be exposed to the FRIENDS program training for children and adolescents in two intervention groups of 15 people during 10 sessions of 60 minutes for 10 weeks at the Comprehensive Hemophilia Center. immediately after completing the training, complete the Liebenberg and Ungar's Child and Youth Resilience Measure-28 item and Health Related Quality of Life Questionnaire "KIDSCREEN-27 item. The training venue is the conference hall of Educational and therapeutic center of Martyr Ayatollah Dastgheib, which has audio-visual facilities.
Participants/Inclusion and exclusion criteria
Admission requirements: age group 13 to 19 years old; at least elementary education. Conditions of non-entry: having another chronic disease; simultaneous participation in similar training sessions.
Intervention groups
Intervention group: the participants in this group are exposed to the FRIENDS program training for children and adolescents in two intervention groups of 15 people during 10 sessions of 60 minutes for 10 weeks at the Comprehensive Hemophilia Center. Control group: non-intervention: this training group will not be given.
Main outcome variables
Resilience and health related quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220712055451N1
Registration date:2022-07-22, 1401/04/31
Registration timing:prospective
Last update:2022-07-22, 1401/04/31
Update count:0
Registration date
2022-07-22, 1401/04/31
Registrant information
Name
Fatemeh Keshavarz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5223
Email address
keshavarz.ftm.2017@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of FRIENDS educational program on resilience and health related quality of life of adolescents with hemophilia
Public title
The effect of FRIENDS educational program on resilience and health related quality of life of adolescents with hemophilia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study and sign the informed consent form by the parent and the adolescent
Simultaneously obtaining a score of less than 74 in the resilience questionnaire and a score of less than 50 in the quality of life questionnaire related to overall health
At least elementary education
Age group 13 to 19 years old
Exclusion criteria:
Having another chronic disease
The presence of mental disorders requiring immediate treatment (such as: psychiatric symptoms, substance dependence, and suicide) and treatment with antidepressants, anxiety medications, or psychotherapy programs or psychological interventions.
Existence of severe stressors in life (such as parents' divorce or bereavement) during the research
Simultaneous participation in similar training sessions
History of participating in similar training courses in the last six months
Age
From 13 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of blocks in such a way that blocks of size 2, 4 and 6 will be used. For example, in the case where the block size is 2, we will have two states AB and BA (A and B are the intervention and control groups). In order to create the sequence and concealment, the online software with the following address will be used and a special randomization code will be generated:
Sealed Envelope Ltd. 2021. Create a blocked randomization list. [online] Available from: http://www.sealedenvelope.com/simple-randomizer/v1/lists [Accessed 16 July 2022]
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 of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2022-07-05, 1401/04/14
Ethics committee reference number
IR.YUMS.REC.1401.046
Health conditions studied
1
Description of health condition studied
Adolescents with hemophilia
ICD-10 code
D66 - D67
ICD-10 code description
Hereditary factor VIII deficiency; Hereditary factor IX deficiency
Primary outcomes
1
Description
Resilience
Timepoint
The level of patients' resilience at the beginning of the study (before the start of the intervention) and immediately after the start of the study
Method of measurement
Liebenberg and Ungar's Child and Youth Resilience Measure-28 item
2
Description
Health related quality of life
Timepoint
The level of patients' health related quality of life at the beginning of the study (before the start of the intervention) and immediately after the start of the study
Method of measurement
Health Related Quality of Life Questionnaire "KIDSCREEN-27 item
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the participants in this group will be exposed to the FRIENDS program training for children and adolescents in two intervention groups of 15 people during 10 sessions of 60 minutes for 10 weeks at the Comprehensive Hemophilia Center.
Category
Lifestyle
2
Description
Control group: non-intervention: this training group will not be given.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and therapeutic center of Martyr Ayatollah Dastgheib
Full name of responsible person
Fatemeh Keshavarz
Street address
Educational and therapeutic center of Martyr Ayatollah Dastgheib, Next to National Park, Hafez St., Shiraz, Fars, Islamic Republic of Iran
City
Shiraz
Province
Fars
Postal code
714563769
Phone
+98 71 3228 8064
Fax
+98 71 3229 8092
Email
keshavarz.ftm.2017@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
nursing@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Keshavarz
Position
Msc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Farhangian Street, Safavi Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7167818775
Phone
+98 71 3612 5223
Email
keshavarz.ftm.2017@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Keshavarz
Position
Msc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Farhangian Street, Safavi Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7167818775
Phone
+98 71 3612 5223
Email
keshavarz.ftm.2017@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Keshavarz
Position
Msc student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Farhangian Street, Safavi Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7167818775
Phone
+98 71 3612 5223
Email
keshavarz.ftm.2017@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