Determining the effectiveness of the educational program on knowledge and caring performance of parents of children with colostomy
Design
Sampling will be done with a sequential non-probability method. With a control group, with parallel groups, the samples will be randomly divided into two test groups (N=39) and control (N=39) using the randomized permutation method
Settings and conduct
The research sample includes 78 infants aged 1 month to 2 years with colostomy. The research environment is teaching hospitals affiliated to Ahvaz University of Medical Sciences. In the test group (39 people), the educational intervention will be implemented in a combined form (face-to-face and showing an educational film approved by the doctor and presenting a pamphlet) by the researcher during 10, 45-minute sessions (one session per week). For the control group, no educational intervention. will not be done.
Participants/Inclusion and exclusion criteria
1. Having a child with colostomy
2. Child age between 1 month and 2 years
3. Not having a history of uncontrolled underlying disease
4.Parents have the ability to receive education (at least elementary literacy level)
5. lack of parents participating in the previous class non criteria
Non-entry conditions: 1. Children below 1 month and above 2 years
2. Lack of proficiency in Persian language
Intervention groups
For the test group, the educational intervention will be conducted in a combined form (face-to-face and showing an educational film approved by the doctor and presentation of a pamphlet) by the researcher during 10, 45-minute sessions (one session per week). No educational intervention will be done for the control group
Main outcome variables
Caring performance of colostomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230507058110N1
Registration date:2023-05-13, 1402/02/23
Registration timing:prospective
Last update:2023-05-13, 1402/02/23
Update count:0
Registration date
2023-05-13, 1402/02/23
Registrant information
Name
Ashrafalsadat Hakim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8268
Email address
sara.kz1989@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-14, 1402/02/24
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of the educational program on knowledge and caring performance of parents of children with colostomy
Public title
Investigating the effectiveness of the educational program on the knowledge and caring performance of parents of children with colostomy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child with colostomy
Child age between 1 month and 2 years
Not having a history of uncontrolled underlying disease
Parents have the ability to receive education (at least elementary literacy level)
lack of parents participating in the previous class
Exclusion criteria:
Children below 1 month and above 2 years
Lack of proficiency in Persian language
Age
From 1 month old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were first selected from among the research community based on the inclusion criteria. The random assignment of the research sample to two intervention and control groups will be done based on quadruple permutation blocks (using the table related to random permutation blocks, of Twenty groups of four). In this method, the number of people assigned to each group is almost equal. Blocks are formed based on the variables in question, and half of the intervention people and half of the control people are included in each block. The main goal is to balance the number of participants in each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling will be done with a sequential non-probability method. With a control group, with parallel groups, the samples will be randomly divided into two test groups (N=39) and control (N=39) using the randomized permutation method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jundishapur University of Medical Sciences, Ahvaz
Street address
Esfand St, Golestan Blvd, University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-05-06, 1402/02/16
Ethics committee reference number
IR.AJUMS.REC.1402.084
Health conditions studied
1
Description of health condition studied
Colostomy
ICD-10 code
k94.00
ICD-10 code description
Colostomy complication, unspecified
Primary outcomes
1
Description
Colostomy
Timepoint
Before the start of the intervention and two months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Colostomy
Timepoint
Before the start of the intervention and two months after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: In intervention group, in order to educate the parents, educational sessions will be held in the form of group discussions, during which the parents will be divided into groups of 6 people. About colostomy, treatment, general care and nursing care will be carried out by the researcher during 10 sessions of 45 minutes (one session per week), and at the end of the training sessions, an educational pamphlet will be provided to them.
Category
Behavior
2
Description
Control group: In the control group, no educational intervention will be done. However, in order to comply with ethical considerations, after analyzing the results, the educational pamphlet will be delivered to the control group.