Effect of an educational- self-help program on the mothers anxiety` of children with cancer in Omid hospital,in 2018
Design
This study is a clinical trial in which 44 mothers of the child with cancer were selected and assigned randomly into 22 mothers in intervention and control group.
Settings and conduct
This study was carried out in Omid haspital in Isfahan. Intervention group attended in a eight session educational-self help program. Mothers filled Hamilton questtioner before and after intervention.
Participants/Inclusion and exclusion criteria
Mothers of the child with cancer
Mothers were not simultaneously participating in some classes reducing anxiety like Yugo
Mothers who agreed to attend in 8 session of scheduled programme
Every alternative problem can affect on the anxiety of mother
Intervention groups
In the first,44 mothers of children with cancer who have inclusion criteria attend in the study.Then, mothers were randomly selected and assigned equally to intervention and control group.
Main outcome variables
Mothers` anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190616043902N1
Registration date:2019-11-30, 1398/09/09
Registration timing:retrospective
Last update:2019-11-30, 1398/09/09
Update count:0
Registration date
2019-11-30, 1398/09/09
Registrant information
Name
Akram Akram
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5748 8527
Email address
akram.gholamiyan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2019-02-19, 1397/11/30
Scientific title
Effect of an educational- self-help program on the mothers anxiety` of children with cancer
Public title
Effect of an educational- self-help program on the mothers of anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who have achild with cancer
Mothers were not simultaneously participating in some classes reducing anxiety like Yugo
Mothers who agreed to attend in 8 session of scheduled programme
Every alternative problem can affect on the anxiety of motherو
Exclusion criteria:
Mothers with the 3 years old child or less
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population includes mothers of children with cancer who are under treatment in Omid Hospital in Isfahan. They are available through a sampling method of 40 individuals. They were randomly drawn and equally allocated to an intervention and a control group.
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 Isfahan University of Medical Sciences
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.MUI.REC.1398.009
Health conditions studied
1
Description of health condition studied
زchildren with cancer
ICD-10 code
ICD-10 code description
cancer
Primary outcomes
1
Description
anxiety
Timepoint
Before and after intervention
Method of measurement
Hamilton questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Educational-self help group programme was done through 8 session for paticipants
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Mahboobeh Namnabati
Street address
shahied Motahari
City
Isfahan
Province
Isfehan
Postal code
00983137927507
Phone
+98 31 3792 7516
Email
namnabat@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Noroozi
Street address
hezar jerib
City
Isfahan
Province
Isfehan
Postal code
3137927516
Phone
+98 31 3792 7532
Email
reseach@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Akram gholamian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar jarib Street
City
Isfhan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7507
Email
akram.gholamian@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboobeh Namnabati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7507
Email
namnabat@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboobeh namnabati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
hezar jerib
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7507
Email
namnabat@nm.mui.ac.ir
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
Yes - There is a plan to make this available
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
Study documentation will be published after the intervention.
When the data will become available and for how long
2020
To whom data/document is available
All undergraduate and postgraduate students
Under which criteria data/document could be used
Researcher-PhD,Ms.Bs Students
From where data/document is obtainable
Namnabat@nm.mui.ac.ir
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What processes are involved for a request to access data/document