Effect of Emotional Regulation Training Based on Grass's Model on anxiety of parents of children with cancer at the Pediatric Center of Qods in 2018
Design
The parents will be divided into two groups of control and test by random assignment using the random allocation rule (allocation of paired or individual scores to selected cases and simple lottery). The sample size for each group is 23, and a total of 46 people will be included in the study. Personal information and Beck Anxiety Inventory will be used to analyze the data.
Settings and conduct
Based on various researches, emotional regulation, in addition to positive effects on mental well-being, improves physical health. This study is done at the Pediatric Center of Qods and on the parents of children referred in available. Blinding has not been done in this study.
Participants/Inclusion and exclusion criteria
Having literacy; Availability of parents; Ability to speak and understand Persian language; Not to receive other psychiatric interventions; No anti-anxiety drugs or other anxiety treatments. Unwillingness to continue cooperation; Absence in a training place at least 2 sessions; Participate in other training programs to control anxiety.
Intervention groups
At first,the Beck Anxiety Test will be taken of two groups of test and control (pre-test). Education Based on Grass Modeling will hold eight sessions for 75 minutes in person and group for the test group and the control will receive routine center actions. Finally, the level of anxiety will be measured by This test (post-test) monthly for six months and the effectiveness of the intervention method will be considered.
Main outcome variables
The effect of emotional Regulation Training Based on Grass's Model in the study group; Measure the anxiety in this groups after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190314043055N1
Registration date:2019-06-30, 1398/04/09
Registration timing:retrospective
Last update:2019-06-30, 1398/04/09
Update count:0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
Sedigheh Bahrami Nasir Mahaleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3257 3208
Email address
s.bahramin@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2019-06-21, 1398/03/31
Scientific title
Effect of Emotional Regulation Training Based on Grass's Model on anxiety of parents of children with cancer at the Pediatric Center of Qods in 2018
Public title
Effect of Emotional Regulation Training Based on Grass's Model on anxiety of parents of children with cancer at the Pediatric Center of Qods in 2018
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Complete written consent form
Having reading and writing skills
The availability of parents of children
Ability to speak and understand Persian language
Not to receive other psychiatric interventions
No anti-anxiety drugs or other anxiety treatments
Exclusion criteria:
Unwillingness to continue cooperation
Absence in a training place at least 2 sessions
Participate in other training programs to control anxiety
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Parents will be divided into two groups by random assignment using the Random Allocation Rule (assigning couple or individual scores to selected files and then simple lottery) to the control and test groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
IR.QUMS.REC.1397.123
Health conditions studied
1
Description of health condition studied
The effect of Emotional Regulation Training based on Grass's Model on anxiety of parents of children with cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Effect of Emotional Regulation Training Based on Grass's Model on anxiety of parents of children with cancer
Timepoint
Eight sessions. 75 minutes per session in person and group for the test group
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
1
Description
Measure of anxiety in parents of children with cancer after intervention
Timepoint
Monthly for 6 months
Method of measurement
Beck Anxiety Inventory
Intervention groups
1
Description
Intervention group: Complete Beck Anxiety Test Questionnaire (pre-test) by parents of children with cancer. Holding 8 training sessions based on the Grass model for 75-minute in each session in person and group. Measure anxiety of parents of children with cancer by Beck Anxiety Inventory questionnaire in monthly for 6 months (post-test)
Category
Behavior
2
Description
Control group: Complete Beck Anxiety Test Questionnaire by parents of children with cancer (Pre-test). Get routine center actions. Measure anxiety of parents of children with cancer by Beck Anxiety Inventory questionnaire in monthly for 6 months (post-test).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Hospital
Full name of responsible person
Sedigheh Bahrami Nasir Mahaleh
Street address
Qods Medical Center, Qods Square, The first of Felestin shargi, Shahid Beheshti Blvd.,
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3334 8071
Email
s.bahramin@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Deputy of Research, Mavedat Subside, Shahid Beheshti Blvd.,
City
Qazvin
Province
Qazvin
Postal code
1391134156
Phone
+98 28 3333 7006
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sedigheh Bahrami Nasir Mahaleh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 27, Sarve 15, Distinct 5, Mohammadieh
City
Qazvin
Province
Qazvin
Postal code
3491637877
Phone
+98 28 3257 3208
Email
s.bahramin@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sedigheh bahrami nasir mahaleh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 27, Sarve 15, Distinct 5, Mohammadieh
City
Qazvin
Province
Qazvin
Postal code
3491637877
Phone
+98 28 3257 3208
Email
s.bahramin@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sedigheh Bahrami Nasir Nahaleh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 27, Sarve 15, Distinct 5, Mohammadieh
City
Qazvin
Province
Qazvin
Postal code
3491637877
Phone
+98 28 3257 3208
Email
s.bahramin@qums.ac.ir
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