Determining the effect of combined education on the knowledge and care-supportive practice of parents with a child with cleft lip and palate
Design
Clinical trial with control group, Samples will be randomly divided into two groups of intervention (N = 20) and control (N = 20) by the method of random permutation blocks with block size 4 (using the table related to random permutations).
Settings and conduct
Forty parents of children with cleft lip and palate who meet the inclusion criteria are enrolled in the study. Then the samples are randomly divided into two groups of intervention and control groups.The study site is located in the Imam Khomeini hospital in ahvaz.
Participants/Inclusion and exclusion criteria
Inclusion criteria for this study included registering and defining diagnosis of cleft lip and palate in child medical records, exclusion criteria was included Parental absenteeism in at least one session of educational classes.
Intervention groups
for the experimental group (20 people), the educational intervention will be performed in combination (face to face and demonstration (educational video approved by the treating physician) by the researcher during 4 sessions of 45 minutes (one session per week). In addition, no educational intervention will be performed for the control group. However, in order to observe ethical considerations, at the end of the training sessions (after the post-test), an educational pamphlet will be given to the control group.
The effect of combined education on the knowledge and care and supportive performance of parents with children with cleft lip and palate
Public title
The effect of combined education on the knowledge and care and supportive performance of parents with children with cleft lip and palate
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Registration and definitive diagnosis of cleft lip and palate in the child's medical record
Parents' mastery of Persian language
Exclusion criteria:
Having psychiatric illness in parents
Drug addiction in parents
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples were randomly divided into two groups of intervention (N = 20) and control (N = 20) by the method of random permutation blocks with block size 4 (using the table related to random permutations).
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 of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand st, Golestan Blvd, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.AJUMS.REC.1397.796
Health conditions studied
1
Description of health condition studied
cleft lip and cleft palate disease
ICD-10 code
XVII
ICD-10 code description
Congenital Malformations, Deformations and Chromosomal Abnormalities
Primary outcomes
1
Description
The level of knowledge and practice of parents with a child with cleft lip and palate
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Researcher-made questionnaire (Assessment of knowledge and performance)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For Intervention group (20 people), the educational intervention will be performed in combination (face to face and demonstration (educational video approved by the treating physician) by the researcher during 4 sessions of 45 minutes (one session per week).
Category
N/A
2
Description
Control group: No educational intervention will be performed for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital and Abuzar Hospital, Ahvaz
Full name of responsible person
Ashrafalsadat Hakim
Street address
Imam khomeini Hospital Azadegan BLV; Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Fax
+98 61 3222 5763
Email
hakim3448200@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand st, Golestan Blvd, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
info@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
50
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
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Pediatric Management
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand st, Golestan Blvd, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
hakim3448200@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Pediatric Management
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand st, Golestan Blvd, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
hakim3448200@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ashrafalsadat Hakim
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Pediatric Management
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand st, Golestan Blvd, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
hakim3448200@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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