The effect of resilience training on psychological well-being and affects of parents with leukemia children’s
Design
Randomized control trial with parallel groups, double-blind (outcome assessment and data analysis)
Settings and conduct
In this study, 62 parents of children with leukemia referred to Amir Kabir Hospital in Arak will be participated.
Participants are randomly divided into intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
25 to 50 years old
Not being diagnosed psychiatric disorders
Passing for at least 3 months of diagnosis of leukemia
Exclusion criteria:
Unwilling of parents to participate in the study
Detection of parental psychiatric disorders during study
Intervention groups
Intervention group:
The intervention group samples will be trained in 9 sessions of 1 hour. The meetings will be held daily. The content of training sessions has been developed by a clinical psychologist.
Control group;
Control group samples do not receive intervention during this period.
Main outcome variables
Psychological well-being; affects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161223031522N9
Registration date:2019-01-22, 1397/11/02
Registration timing:registered_while_recruiting
Last update:2019-01-22, 1397/11/02
Update count:0
Registration date
2019-01-22, 1397/11/02
Registrant information
Name
Vahid Naseri Salahshour
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
v.naserisalahshour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Resilience Training on Psychological Well-being and Affects of Parents with Leukemia Children’s
Public title
The Effect of Resilience Training on Psychological Well-being and Affects of Parents with Leukemia Children’s
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
25 to 50 years old
Not being diagnosed psychiatric disorders
Passing for at least 3 months of diagnosis of leukemia
Exclusion criteria:
Unwilling of parents to participate in the study
Detection of parental psychiatric disorders during study
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The samples individually divided into two intervention and control groups using simple random allocation method and using the random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome evaluator and data analyzer do not know about allocation of people to intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.ARAKMU.REC.1397.197
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
C95
ICD-10 code description
Leukaemia of unspecified cell type
Primary outcomes
1
Description
Score of psychological well-being of the scale of Ryff
Timepoint
Before the study and 9 days after the intervention
Method of measurement
Ryff score of psychological well-being
2
Description
Score of positive and negative affect of PANAS questionnaire
Timepoint
Before the study and 9 days after the intervention
Method of measurement
PANAS positive and negative affect questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group samples will be trained during 9 sessions of 1 hour. Meetings will be held daily. The content of training sessions has been developed by a clinical psychologist.
Category
Behavior
2
Description
Control group: Control group samples do not receive intervention during this period.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Alireza Kamali
Street address
Shahid Shiroodi St., Parastar Sq.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4717
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
vahidnaseri1994@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour
Position
MSc of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
vahidnaseri1994@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour
Position
MSc of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
vahidnaseri1994@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared.
When the data will become available and for how long
48 months after the publishing of the results.
To whom data/document is available
Researchers in academic and scientific institutions.
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
E-mail address: sajadimahbobeh@yahoo.com
What processes are involved for a request to access data/document
After receiving the email, the information will be sent within 2 to 3 working days.