The effect of psycho-educational interventions on resilience of mothers who have 1-3 year old children with chronic liver diseases leading to cirrhosis
1) Aims: To examine the effect of educational-psychological interventions on the resilience of mothers with children aged 1-3 years with chronic liver disease leading to cirrhosis. 2) Design: in this clinical trial study, 83 mothers with children with chronic illness led to cirrhosis of the liver, who were eligible for inclusion in the study, were selected by multi-permutational block method and randomly divided into two groups Test (n = 41) and control (n = 42). 4) Inclusion and exclusion criteria: mothers with children aged 1 to 3 years with chronic liver disease leading to cirrhosis; Absence of a crisis or stressful event such as divorce, separation from husband, imprisonment, death of a family member, loss of job and family disputes during the past year and during the study. 5) Interventions: The test group participated in six sessions of 45 minutes three times a week, and the control group did not receive intervention. 6) Main outcome variables: Maternal resilience score before, immediately after and one month after intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062434732N1
Registration date:2017-08-14, 1396/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-14, 1396/05/23
Registrant information
Name
Minoolaleh Haghshenas
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
stud2297987382@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Shiraz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psycho-educational interventions on resilience of mothers who have 1-3 year old children with chronic liver diseases leading to cirrhosis
Public title
The effect of psycho-educational interventions on resilience of mothers who have 1-3 year old children with chronic liver diseases leading to cirrhosis referring to centers related to Shiraz University of Medical Sciences 2015
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria for entering the study: - Age of the mother older than 18 years; - Inclination to participate in the study; - Completion of the consent form; - Farsi language proficiency and at least reading and writing literacy; - Non-emergence of a crisis or stressful event such as divorce, separation from the spouse, Imprisonment, death of a family member, loss of job and family disputes over the past year and during the study - the lack of use of sedative and anti-anxiety drugs according to the mother - no physical or mental illness that participated in the intervention Mother interferes, according to her mother - No participation in other educational programs during the study - No chronic disease. Air of children or family - Absence of a member of the medical and care staff - Confirmation of chronic liver disease leads to cirrhosis of the child by a specialist - age of the child is between 1-3 years of age - Non-hospitalization of the child during the study period Exit criteria: - Lack of Desire to cooperate during the study - Absence of more than 2 sessions in classes - Severe illness or child death
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
83
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shiraz University of Medical Sciences
Street address
Zand street, Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2015-11-29, 1394/09/08
Ethics committee reference number
IR.SUMS.REC.1394.139
Health conditions studied
1
Description of health condition studied
Chronic liver disease leads to cirrhosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
resilience
Timepoint
before, immediately and one month after intervention
Control group: After completing the questionnaires, the control group is given a booklet
Category
Behavior
2
Description
intervention group: face to face education in accordance with the educational booklet for mothers of children with chronic liver disease leading to cirrhosis
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Fars Province, Shiraz, Zand
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
Master of Pedagogy Nursing, Faculty Member
Other areas of specialty/work
Street address
Nursing And Midwifery College, Namazi Squre, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 98713647428
Fax
Email
Mitraedraki@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing And Midwifery College University in Shiraz, Iran
Full name of responsible person
Mitra Edraki
Position
Master of Pedagogy Nursing, Faculty Member
Other areas of specialty/work
Street address
Nursing And Midwifery College University in Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 98713647428
Fax
Email
mitraedraki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Minoolaleh Haghshenas
Position
Master's student of neonatal intensive care nursing
Other areas of specialty/work
Street address
Nursing And Midwifery College University in Shiraz, Iran
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)