Determining the Effect of Maternal Empowerment Training on Prevention of Complications of Chemotherapy in Children With Cancer Referring to Selected Hospital Affiliated to Tehran University of Medical Sciences in 1396
Design
Non-randomized (non-probable) random sampling units were selected and randomly divided into two groups of control and test groups. Each group included 20 subjects.
Settings and conduct
In this research, a randomized clinical trial study, the control and control groups were selected and studied during 2 months. The data were collected during the following stages:
The researcher was referred to an outpatient chemotherapy department. Subsequently, the mothers who had entered the study were selected by non-randomized sampling method (non-probable) and then divided randomly into two groups (control and test groups) In each group, 20 subjects were studied. The research objectives were explained to the research units and meetings were held to empower mothers in the outpatient chemotherapy hall.
The intervention stage was performed only for the test group
Participants/Inclusion and exclusion criteria
"Entry requirements"
A child under 12 years of age with a definite diagnosis of cancer; the child is undergoing chemotherapy (at least 1 course of chemotherapy and maximum 3 chemotherapy courses); the mother have a mental health; the mother does not have a disabling illness; do not complete a special educational course such as classes Chemotherapy education
Health care personnel
"Failure to enter"
Mother has chronic illness
Intervention groups
The intervention group includes mothers who have empowerment training for them
The control group includes mothers who do not receive empowerment training
Main outcome variables
Complications of chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180121038467N1
Registration date:2018-10-06, 1397/07/14
Registration timing:retrospective
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Leila lashgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3522 9033
Email address
l.lashgari@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-11-22, 1396/09/01
Actual recruitment end date
2018-01-20, 1396/10/30
Trial completion date
2018-01-20, 1396/10/30
Scientific title
The effect of mothers' empowerment training on prevention of chemotherapy complications in children with cancer
Public title
The effect of empowerment of mothers on the prevention of complications of chemotherapy in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
For a child, chemotherapy has begun
Mother has mental health
Mother has no debilitating illness
Do not pass specific educational courses such as chemotherapy classes
Exclusion criteria:
Mothers with chronic diseases
Children who, in addition to cancer, have another chronic illness
Age
From 1 year old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
40
20 people in both groups
Actual sample size reached:
40
More than 1 sample in each individual
Actual sample size in each individual:
20
Twenty in the case group and 20 in the control group were selected and included mothers who brought their children to outpatient chemotherapy at the Bahrami Children's Hospital
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomized case that uses a random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
58/5000In this study, a 4-part empowerment model was used
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research in Azad University, Tehran Medical Sciences Branch
Street address
8, Kiani Alley, Imam Hossein Square, Damavand St. Bahrami Hospital
City
Tehran
Province
Tehran
Postal code
3439123900
Approval date
2017-07-26, 1396/05/04
Ethics committee reference number
IR.IAU.TMU.REC.1396.64
Health conditions studied
1
Description of health condition studied
Prevention of chemotherapy complications in children under chemotherapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Complications of chemotherapy
Timepoint
The second week, the fourth week, the eighth week
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: In the experimental group, training was conducted based on the steps of empowerment model in 5 one-hour sessions, the steps of which were as follows: Step One: This step was conducted by a researcher in two sessions of one hour by lecture and group discussion with the aim of increasing knowledge And understanding and then understanding the threat through awareness of the nature and complications of the disease, exacerbating factors and important points of control and prevention of complications and effective factors in controlling the disease, and in particular infection control. PowerPoint, and pamphlet were used at this stage. Mothers were divided into four groups of five. Step two: This phase was conducted with group discussion during 3 sessions of one hour. At this stage, mothers were faced with a real problem. The experiences of each other were known to solve the problems of chemotherapy and its better control, and there were concrete examples of the situation of the child and what they did to improve the problem. The purpose of the meeting was to increase the self-esteem, self-esteem and self-control of mothers. The best solution for solving children's problems was choosing the appropriate nutrition style and infection control, preventing complications by lecture method. Step 3: At the end of each session, patients were asked to promote self esteem and self-esteem through the educational participation, the topics discussed in Educational sessions were shared with the exchange of information, and a number of questions were asked by the researcher of the mothers and a booklet was given to them and the mothers were asked to explain the information to other members of the family. Step Four: To evaluate before each session Ask questions about the topics discussed to ensure you learn the content SAT took place then gave moms an opportunity during this period By placing the phone, the researcher solved the questions posed by the mother in implementing the empowerment model.
Category
Prevention
2
Description
Control group: "There was no intervention for the control group and ethically, after the completion of the research, all educational issues were distributed as CDs and educational manuals and provided to the control group"
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Street Kiani Children's Hospital Bahrami Tehran
Full name of responsible person
Shams al-Muluk Jalal Manesh
Street address
Bahrami Children's Hospital, Imam Hossein Square, Damavand St., Shahid Kayani St. (Qasem Abad Station)
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 7301 3000
Email
hosp_bahrami@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shams al-Muluk Jalal Manesh
Street address
Shariati street, Ghods Square
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2261 8513
Email
iautmu@iautmu.ac.ir
Grant name
Azad University of Medical Sciences, Tehran University of Medical Sciences, Faculty of Nursing and Midwifery
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Shams al-Muluk Jalal Manesh
Position
University faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tehran Shariati Avenue, Quds Square
City
Tehran
Province
Tehran
Postal code
2951, 1994
Phone
+98 21 6645 4983
Email
leilalashkari872@gimal.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shams al-Muluk Jalal Manesh
Position
University faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran Shariati Avenue, Quds Square
City
Tehran
Province
Tehran
Postal code
2951, 1994
Phone
+98 21 6645 4983
Email
leilalashkari872@gimal.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shams al-Muluk Jalal Manesh
Position
University faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shariati avenue, Ghods Square
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 21 6645 4983
Email
leilalashkari872@gimal.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