The aim of this randomized controlled clinical trial is to determine the impact of multimedia education on the knowledge and practice of mothers of infants with colostomy. In this study; 60 mothers of the infants with colostomy will contributed. Inclusion criteria: infants aged between 2-28 days; having colostomy due to a disease of the digestive system; infants with only malformations of the digestive system; 2 days after the infants surgery; mothers' willingness to participate in the study; mothers should be a main caregiver; mothers who are literate) and the mother will be excluded from study in the case of infant death or cooperation refusal. All mothers of the infants with colostomy will be randomly assigned into two groups by using sealed envelopes. There is written allocation code of participants study groups. The intervention group will learn how to take care of colostomy through using one CD and control group will learn the process using one booklet. Booklet and CD contents both are identical. In both groups; knowledge questionnaire and practice checklist will be completed before intervention and 5 days and one month after intervention and mean of mothers' knowledge and practice will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601264613N17
Registration date:2016-10-01, 1395/07/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-01, 1395/07/10
Registrant information
Name
Sousan Valizadeh Dehkharghani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
009804134751706- 34796770
Email address
valizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Sciences
Expected recruitment start date
2016-09-29, 1395/07/08
Expected recruitment end date
2017-01-18, 1395/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of multi-media education on the knowledge and practice of mothers of infants with colostomy :A randomized clinical trail
Public title
Multi-media education's impact on the knowledge and practice of mothers of infants with colostomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for mothers: age between 18-45 years; mothers' willingness to participate in the study; mothers should be a main caregiver; mothers who are literate.
Inclusion criteria for infants: age 2-28 days; with colostomy due to a disease of the digestive system; only malformations of the digestive system; 2 days after the infants surgery.
Exclusion criteria from study in the case noncooperation or refusal of mother.
Exclusion criterion for infants: infant death
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All mothers of the infants with colostomy will be randomly assigned into two groups by using sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional committee of ethics in medical research of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Iran
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.TBZMED.REC.1395.603
Health conditions studied
1
Description of health condition studied
infants colostomy
ICD-10 code
Z93.3
ICD-10 code description
Colostomy status
Primary outcomes
1
Description
Mothers' knowledge
Timepoint
Before intervention, 5 days and 1 month after intervention
Method of measurement
Knowledge questionaire
2
Description
Practice of mothers
Timepoint
Before intervention and 5 days and 1 month after intervention
Method of measurement
Observation checklist for practice
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive the education on how to take care of colostomy through a film that will be displayed by researcher personal laptop in a twenty-minute session.
Category
N/A
2
Description
Control group will learn how to take care of colostomy using routine booklet in one twenty-minute session.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Akram Mehri Gavgani
Street address
Sheshgelan street, before Qari bridge
City
Tabriz
2
Recruitment center
Name of recruitment center
Mofid Children's Hospital
Full name of responsible person
Dr. Ahmad Khalegh Nejad Tabari
Street address
Mofid Children's Hospital, near Mirdamad Blvd., Dr Ali Shariaty Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Deputy of Research and Technology,Tabriz University of Medical Sciences, Golgasht street,Tabriz, East Azarbaijan,
City
Tabriz
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 Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Akram Mehri Gavgani
Position
Student of master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, South Shariati Street , Tabriz
City
Tabriz
Postal code
44199-51668
Phone
+98 41 3442 4864
Fax
Email
ayleen1386@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Sousan Valizadeh
Position
Associate professor of Child health and Neonatal Intensive Care Department,Phd in Nursing Education
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, South Shariati Street,Tabriz, Iran
City
Tabriz
Postal code
44199-51668
Phone
+98 41 3479 0364
Fax
+98 41 3479 6969
Email
valizades@tbzmed.ac.irvalizadehsousan13@gmail.com
Web page address
http://researchvice.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Universityof Medical Sciences
Full name of responsible person
Akram Mehri Gavgani
Position
Student of Master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Postal code
44199-51668
Phone
+98 41 3479 0364
Fax
+98 41 3479 0364
Email
ayleen1386@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)