The aim of present study is to determine the effect of resiliency against child disease intervention in mothers with children suffering from cancer
Design
The clinical trial includes 24 in control group and 24 in intervention groups on mothers of children with cancer, based on resiliency, with parallel groups, not blinded, randomized
Settings and conduct
The present study will be done in mothers with a cancerous child referring to the Motahhari Educational Center of Urmia in 2017. In this experimental study, a pre-test-post-test design with control group will be used.In order to conduct this research, 48 people will be selected from the population and randomly will be assigned into two experimental groups (24 people) and controls (24 people). Intervention for the experimental group will be in 6 sessions in a 60 to 90-minute coping program .
Participants/Inclusion and exclusion criteria
Inclusion criteria include mothers with a child who are diagnosed with a disease under six months. Participants with a GHQ below 23 those who do not use psychosocial drugs or tobacco, have no other sick child, the child's parents live together, child's father does not have addiction, the child's father is not imprisoned, they are aware of their child's illness, they did not participated in similar programs during the last six months and have not lost their relatives in the past six months will be selected. Participants with a GHQ over 23 and not participated in more than one session of intervention will be excluded from the study.
Intervention groups
The first group consists of 24 mothers of children with cancer who will undergo intervention resilliancy
The second group consisted of 24 mothers of children with cancer and the control group received no intervention.
Main outcome variables
Coping with child illness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140212016564N12
Registration date:2018-08-01, 1397/05/10
Registration timing:retrospective
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Molood Radfar
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1275 4961
Email address
radfar.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Personnel costs 0 Total costs of testing and specialist services 0 Total travel expenses 3,470,000 Total equipment costs 1,500,000 Total other costs 0 Credit from other organizations 6,770,000 Rials Total
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2017-09-23, 1396/07/01
Trial completion date
empty
Scientific title
The effect of group therapy intervention based on Resiliency against child disease in mothers with children suffering from cancer
Public title
The effect of group therapy intervention based on Resiliency against child disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
mothers with a child who are diagnosed with a disease under six months.
low GHQ are 23,
do not use psychoactive drugs or tobacco
have no other sick children
live together with parents
have no knowledge of their child's illness
have not participated in the same 6 months in the same program
6 Last month did not miss someone or relatives
Speek Persian or azari
residing in Urmia
Exclusion criteria:
Being infected with another disease
Not attending more than one session of intervention sessions
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
They will be assigned into groups randomly. To do so 24 A cards and 24 B cards will be put in the envelope and will be mixed thoroughly (A represents the intervention group and B represents the control group), each individual participating in the study takes one of the cards and enters the study, respectively.
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 Urmia University of Medical Sciences
Street address
Resalat Street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
ir.umsu.rec.1396.154
Health conditions studied
1
Description of health condition studied
Coping with child desiease in mothers with child suffering from cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
cope with child Disease
Timepoint
Before the intervention andT immediately after the intervention and three months after the intervention
Method of measurement
Coping health inventory for parents (CHIP)
Secondary outcomes
empty
Intervention groups
1
Description
A total of 48 mothers with cancerous children referred to the Motahari Hospital of Urmia were selected by available sampling method.The subjects were randomly divided into two groups of control and intervention (n = 24).The sessions for the intervention group were grouped in In three groups of eight in the hospital hall and between 15 and 17 days on Sunday, Tuesday, and Thursday.A meeting was organized for parents to receive a child-centered pre-test.Then, along with the purpose of the study, an interventional program adjusted for resilience in three dimensions: familiarity with the concept of resilience and the characteristics of resilient people / internal and external support factors / familiarity with ways to create resilience, and during 6 sessions, each session The intervention group was administered for 60 to 90 minutes.At the end of each meeting, a maternity homework task will be presented and reviewed at the next meeting. At the end of the work, those who received more points were rewarded. After the end of the sessions, the chip Questionnaire was completed at the end of the last session and 3 months after the intervention for both groups.
Category
Behavior
2
Description
Control group: During the intervention, the control group did not receive any Resiliency and coping skills and in terms of data entry was about control. After completing the intervention, they participated in a meeting on resilience skills.This group controlled and treated with usual and ordinary care approaches that are available in the center.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Education medicall Center
Full name of responsible person
Moloud Radfar
Street address
Kashani Street
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4921
Fax
+98 44 3275 4921
Email
info@motahari.org
Web page address
http://www.umsu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Mohebbie Erag
Street address
Urjance alley, Resalat Blvd, Urmia, Iran
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3275 4921
Fax
+98 44 3275 4921
Email
Mohebbi_iraj@yahoo.co.uk
Web page address
http://www.umsu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
fatemeh hoseinzadeh
Position
The Master Science student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Urmia University of Medical Sciences
City
urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3223 4897
Fax
Email
h.samira58@gmail.com
Web page address
http://www.umsu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
molud radfar
Position
Nursing PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran
City
urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3197 7000
Fax
Email
mradfar1343@gmail.com
Web page address
http://www.umsu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
fatemeh hosseinzadeh
Position
the master science student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Urmia Nursing and Midwifery Faculty
City
urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3384 4660
Fax
Email
h.samira58@gmail.com
Web page address
http://www.umsu.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The whole data will be shared after being unidentified.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
The data will be available to other researchers in the form of a printed article. Other researchers are allowed from the research team to use the data
From where data/document is obtainable
Radfar moloud Email:mradfar1343@gmail.com
What processes are involved for a request to access data/document
You will submit your application to Mrs. Radfar, who will send you the requested application within ten days after reviewing your request.