Comparison of self-care education with two methods of Teach-back and pictorial on self-efficacy and wound healing of stoma in patients with colostomy
Design
A randomized clinical trial with a control group, with three parallel groups
Settings and conduct
The present study will be performed in three groups of 111 patients with colostomy ( two intervention groups and one control group) at Basat hospital of Hamadan in 2019. In the two intervention groups, training will be taught in two methods of teach-back and pictorial. Training sessions will be held on the cause of colostomy, ostomy care methods and types of colostomy bags.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having literacy of reading and writing, Undergoing colostomy surgery for the first time, Ages between 18 to 65 years
Exclusion criteria: Failure to attend more than one training session, Discharge before the end of the intervention
Intervention groups
The tutorial will be run using the teach-back and pictorial method. In teach-back method, educational content will be taught to the patient by a face-to-face researcher in plain language without the use of medical terminology then the patient is asked to express the educational content in their own language. Pictorial training will be done with simple pictures, posters, and drug labels to remind of taking medications. In control group face-to-face training will be done at the time of admission ( as routine training) in the ward.
Main outcome variables
Self-efficacy and wound healing of ostomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N27
Registration date:2019-09-08, 1398/06/17
Registration timing:registered_while_recruiting
Last update:2019-09-08, 1398/06/17
Update count:0
Registration date
2019-09-08, 1398/06/17
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of self-care education with two methods of Teach-back and pictorial on self-efficacy and wound healing of stoma in patients with colostomy
Public title
Comparison of self-care education with two methods of Teach-back and pictorial on self-efficacy and wound healing of stoma
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 18 to 65 years
Undergoing colostomy surgery for the first time
Having literacy of reading and writing
Exclusion criteria:
Not willing to participate in the study
Transfer the patient to another health center
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation will be done using a random number table. Patients will be randomly divided into three groups intervention(A, B) and control (c).
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.UMSHA.REC.1398.328
Health conditions studied
1
Description of health condition studied
Colostomy
ICD-10 code
Z43.3
ICD-10 code description
Encounter for attention to colostomy
Primary outcomes
1
Description
Self- efficacy and stoma wound healing
Timepoint
Before and one month after intervention
Method of measurement
Ostoma self-efficacy questionnaire and assess the skin around the stoma with a checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group(1): The tutorial will be run using the teach-back method. Educational content will be taught to the patient by a face-to-face researcher in plain language without the use of medical terminology. The patient is then asked to express the educational content in his / her own language. If the patient does not understand correctly, the content will be re-educated.
Category
N/A
2
Description
Intervention group(2): Training will be done with simple pictures, posters, and drug labels to remind of taking medications .
Category
N/A
3
Description
Control group: In the control group face-to-face training will be done at the time of admission( as routin education) in the ward.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Mahnaz Khatiban
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khatiban@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
Proportion provided by this source
100
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
Hamedan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khatiban@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khatiban@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zoleikha Rajabi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
nasrinrajabi.md@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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