The aim of this study was to determine the effect of peer education on quality of life of caregivers that they were family members of children with leukemia. Inclusion criteria for children in this research was they must be at least one course of chemotherapy and their age between 1-7 years; for caregivers their age have to more than 18 years. Exclusion criteria was death in children during the study and withdrew caregivers from continuing to participate in the study. The study population consisted of caregivers of children with leukemia in two center of blood Ali Asghar Hospital and Children's Medical Center. Number of participants in intervention and control group was 34 and 37 people respectively. This study was held pre-test at baseline and post-test one month after the last intervention. Intervention to the experimental group was trained caregivers with peer group that includes 4 sessions of 60 minutes in a row, in the form of lectures and group discussions, and each group consisting of 5 to 10 people, by those trained in small groups held a friendly environment. The control group was considered normal care without any intervention. Persian version of quality of life questionnaire was used to assess intervention in this research.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021232522N1
Registration date:2017-06-14, 1396/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Simin Valinezhad Alvar
Name of organization / entity
University of Iran Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6557 7001
Email address
valinezhad.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, School of Nursing and Midwifery
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of peer education on quality of life of family caregivers of children with leukemia
Public title
Quality of life for caregivers of family members of children with leukemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: children must be at least one course of chemotherapy; having a primary caregiver in the family; age between 1-7 years; workers have more than 18 years; have the ability to speak; read and write; lack of any chronic mental disorder. exclusion criteria: carers member of the peer group; a history of participating in training programs on child's illness; death in children during the study; withdrew workers from continuing to participate in the study; the absence of more than one session training class in carers member groups.
Age
From 1 year old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
71
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Iran Medical Sciences
Street address
Besides Milad Tower Tehran Highway martyr Hemmat
City
Tehran
Postal code
1449614535
Approval date
2016-05-28, 1395/03/08
Ethics committee reference number
IR.IUMS.REC1395.9211196243
Health conditions studied
1
Description of health condition studied
leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia
Primary outcomes
1
Description
Quality of life
Timepoint
before intervention, one month after intervention
Method of measurement
Caregivers of people with cancer quality of life questionnaire (CQOLC - P)
Secondary outcomes
1
Description
we don't have any secondary measure
Timepoint
we don't have any secondary outcome time point
Method of measurement
we don't have any secondary outcome method of measurement
Intervention groups
1
Description
There was no intervention in the control group and at the same time with the intervention group the quality of life questionnaire at baseline and one month after the last training session was given to them.
Category
Treatment - Drugs
2
Description
Intervention program include two weeks, two sessions per week and 60 minutes per session. The program was performed in groups. Each group contains 8 to 10 people. In intervention group, instructions was taught by trained peers from sources which researcher given to them in the form of booklets, pamphlets and PowerPoint . The Quality of Life Questionnaire at baseline and one month after the last training session was given to the intervention group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Simin Valinezhad Alvar
Street address
Tehran Keshavarz Blvd. Street doctor Gharib next to Imam Khomeini Hospital Children's Medical Center
City
Tehran
2
Recruitment center
Name of recruitment center
Hazrat Ali Asghar hospital (AS)
Full name of responsible person
Simin Valinezhad Alvar
Street address
City
Tehran Shariati Street martyr Dastagird (Zafar)
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Nursing University of Medical Sciences Of Iran
Full name of responsible person
Dr. Nahid Akbari
Street address
Tehran Vali Asr Street Vanak Street martyr Rashid Yassami University's School of Nursing and Midwifery
City
Tehran
Grant name
Grant code / Reference number
9211196243
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing University of Medical Sciences Of Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Simin valinezhad Alvar
Position
Children's Nursing Graduate Student
Other areas of specialty/work
Street address
Tehran Vali Asr Street Vanak Street martyr Rashid Yassami University's School of Nursing and Midwifery
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
fnm@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Facultymember of Iran University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Khanjari
Position
Director of nursing children and newborns
Other areas of specialty/work
Street address
Tehran Vali Asr Street Vanak Street martyr Rashid Yassami University's School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
sed. khanjari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Simin Valinezhad Alvar
Position
Children's Nursing Graduate Student
Other areas of specialty/work
Street address
City
Tehran
Postal code
1996713883
Phone
Fax
Email
fnm@iums.ac.ir
Web page address
fnm.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)