Protocol summary

Study aim
Effect of peer education on stress , anxiety and depression in mothers of children with leukemia
Design
Quasi- experimental with a control group
Settings and conduct
For the intervention group, 4 sessions of 30 to 45 minutes are performed face to face in groups of 3-5 women,the approved educational booklet will be taught to the mothers of the intervention group by their peers. The DASS-21 questionnaire will be completed at the beginning of the study and one, two months later by the mothers of this group. The control group also receives section routines.
Participants/Inclusion and exclusion criteria
No anti-anxiety and depression drugs Persian language proficiency Passed at least 6 months from the diagnosis of a child's illness Absence in the same sessions and classes lack of other stressful events other than childhood during the past 6 month
Intervention groups
For the intervention group, 4 sessions of 30 to 45 minutes are available in groups of 3 to 5 mothers, and a two-way approved by the academic staff on the diagnosis of leukemia, symptoms, treatments، diet, exercise and proper care , stress management methods are provided to the mothers of the intervention group by their peers. The control group also receives section routines.
Main outcome variables
Peer Education

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160119026104N9
Registration date: 2019-10-26, 1398/08/04
Registration timing: registered_while_recruiting

Last update: 2019-10-26, 1398/08/04
Update count: 0
Registration date
2019-10-26, 1398/08/04
Registrant information
Name
Mahnaz Shoghi
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4687 1192
Email address
shoghi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peer education on stress , anxiety and depression in mothers of children with leukemia
Public title
Effect of peer on stress , anxiety and depression in mothers of children with leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No anti-anxiety and depression drugs Persian language proficiency Passed at least 6 months from the diagnosis of a child's illness Absence in the same sessions and classes
Exclusion criteria:
History of psychological illness Other stressful events other than childhood during the past 6 month
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran, Valiasr Ave., higher than Vanak Square, Rashidiassemi Avenue, Iran Nursing Midwifery Faculty
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
IR.IUMS.REC.1397.778

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
Z63.7
ICD-10 code description
Other stressful life events affecting family and household

2

Description of health condition studied
Stress
ICD-10 code
Z63.7
ICD-10 code description
Other stressful life events affecting family and household

3

Description of health condition studied
Depression
ICD-10 code
R68.8
ICD-10 code description
Other general symptoms and signs

Primary outcomes

1

Description
Stress
Timepoint
The beginning of the study (before the study began) and one month، two month later
Method of measurement
Questionnaire DASS-21(Depression‚ Anxiety‚ Stress Scale 21)

2

Description
Anxiety
Timepoint
The beginning of the study (before the study began) and one month، two month later
Method of measurement
Questionnaire DASS-21(Depression‚ Anxiety‚ Stress Scale 21)

3

Description
Depression
Timepoint
The beginning of the study (before the study began) and one month، two month later
Method of measurement
Questionnaire DASS-21 (Depression‚ Anxiety‚ Stress Scale 21)

Secondary outcomes

empty

Intervention groups

1

Description
A total of 70 children with cancer who are eligible to participate in the study will be selected using the available method and will be included in the study. After explaining the actions and obtaining the informed consent, in the first stage, "before intervention," the anxiety and stress,depression of the mothers of both intervention groups And control is measured by questionnaire. This intervention with peers run during the childhood admission of children in the hospital during the days when the conditions of the child, mother and child are allowed to run every day, which includes 4 sessions of 30 to 45 minutes in groups of 3-5 people, and a booklet prepared ; was given to the mothers of the intervention group.After the completion of the sessions, DASS-21 questionnaire will be completed after one and two month by the intervention group participants. It should be noted that there is no intervention for the control group and they will be under the usual care of the department. At the end of the study, a booklet will be provided to the control group participants
Category
Other

2

Description
Control group:Approved instruction booklet
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Childrens medical center
Full name of responsible person
Tahereh Mohamadzadeh
Street address
Number 62, Childrens Medical Center, Dr. Qarib street, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1511419733
Phone
+98 21 6147 2917
Email
cmc.tums@gmail.com

2

Recruitment center
Name of recruitment center
Hazrat Ali Asghar Hospital
Full name of responsible person
Soroor Sohrabi
Street address
Ali Asghar hospital, Shahid Dasgerdi street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2041
Email
soroor.soh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seid Kazam Malakuti
Street address
School of Nursing and Midwifery, Shahid Yasemi Street., North Kordestan Highway., Tehran., IRA
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Valiasr Ave, above Vanak Square, Rashid Yasemi Ave., Iran Nursing Midwifery Faculty
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Shoghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahid Yasemi Street., North Kordestan Highway., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shoghi.m@iums.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
Not applicable
Title and more details about the data/document
After Data coding in order to keep the confidentiality of the participants in the research.
When the data will become available and for how long
The end of sampling till six months after article publishing.
To whom data/document is available
Ethical, Reviewer and Editorial committees, Researchers.
Under which criteria data/document could be used
Systematic review and meta-analysis or secondary analysis citation
From where data/document is obtainable
Mahnaz Shoghi, Email: shoghi.m@iums.ac.ir
What processes are involved for a request to access data/document
After sending a request to academic email, we will send our data files up to one week.
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