Determining the effect of telenursing based training on the self-efficacy of patients with stoma in Zahedan city in 2022
Design
First, we select 80 patients with stoma who meet the study entry criteria as available sampling, then, using blue and green color cards that are in the white envelopes, we randomly divide the patients into two groups of 40 people, intervention and control.
Settings and conduct
Patient information is obtained from the archives of hospitals covered by Zahedan University of Medical Sciences. Patients will be selected who have had at least one month since their ostomy surgery; Because they have faced problems and limitations.
Participants/Inclusion and exclusion criteria
The patient has not participated in stoma care training courses
A member of the patient's family should not be part of the treatment staff
The patient is not from the treatment staff
The patient should not be supported by the Iran Ostomy Association
At least one month has passed since the patient's ostomy surgery
The age of people should be between 14 and 70 years
The patient or their family caregiver has the ability to work with software and smart phones
The patient does not have any impairment in speech, hearing or vision
The patient has a smart phone
The patient must live in Zahedan city
Intervention groups
patients are randomly divided into two control and intervention groups after available sampling. The control group only sees routine trainings; the intervention group, in addition to routine trainings, receives the special training of the researcher, which is prepared in the from of an application installed on the smart mobaile phone of the patients and they are trained. Patients' self_efficacy is measured by the stoma self_efficacy scale questionnaire before the intervention, one and three months after the intervention.
Main outcome variables
Self_efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230303057596N1
Registration date:2023-07-31, 1402/05/09
Registration timing:registered_while_recruiting
Last update:2023-07-31, 1402/05/09
Update count:0
Registration date
2023-07-31, 1402/05/09
Registrant information
Name
Mostafa Parsa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5542 1977
Email address
parsam3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telenursing based training on the self-efficacy of patients with stoma.
Public title
The effect of telenursing based training on the self-efficacy of patients with stoma.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has not participated in stoma care training courses
A member of the patient's family should not be part of the treatment staff
The patient is not from the treatment staff
The patient should not be supported by the Iran Ostomy Association
At least one month has passed since the patient's ostomy surgery
The age of people should be between 14 and 70 years
The patient or their family caregiver has the ability to work with software and smart phones
The patient does not have any impairment in speech, hearing or vision
The patient has a smart phone
The patient must live in Zahedan city
Also, patients who have a stoma due to cancer with grade 1 and 2 can enter the study
Exclusion criteria:
Cancer patients with grade 3 and 4
Age
From 14 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups of intervention and control by selecting colored cards that fall into a white envelope. Green and blue colored cards are prepared and randomly placed inside a white envelope and patients will randomly choose a card. Green is a sign of the patient's entry into the control group and the blue is a sign of the patient's entry into the intervention group.
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
Zahedan University of Medical Sciences (Research Ethics Committee)
Street address
Persian Gulf Highway, Salamat Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2022-11-20, 1401/08/29
Ethics committee reference number
IR.ZAUMS.REC.1401.420
Health conditions studied
1
Description of health condition studied
stoma
ICD-10 code
Z93.3
ICD-10 code description
Colostomy status
Primary outcomes
1
Description
self-efficacy score
Timepoint
Before starting the study, one month and three months after the intervention
Method of measurement
Stoma self-efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the self-efficacy questionnaire is given to patients to complete. Then in this group, in addition to the routine trainings that the patients receive, the researcher installs special trainings using an application on the patients' smart phones and teaches them. Patients have 3 weeks to be trained using the mobile application. One and three months after the intervention, the self-efficacy questionnaire will be given to the patients to be completed.
Category
Lifestyle
2
Description
Control group: First, the self-efficacy questionnaire is given to patients to complete. The educational program is not installed on the mobile phones of these patients. These patients are not given any special training. َAfter one and three months, the self-efficacy guestionnaire is given to the patients to be completed.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital
Full name of responsible person
DR.Amir Gergij
Street address
Ali Ibn Abi Talib Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
nur.mostafa.parsa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences, Research assistant
Full name of responsible person
Nur Mohammad Bakhshani
Street address
Dr. Hasabi Square - Zahedan University of Medical Sciences campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Nur.mostafa.parsa@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences, Research assistant
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
Zahedan University of Medical Sciences
Full name of responsible person
Mostafa Parsa
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9681944691
Phone
+98 51 5542 1977
Fax
Email
Nur.mostafa.parsa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mostafa Parsa
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9681944691
Phone
+98 51 5542 1977
Fax
Email
Nur.mostafa.parsa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mostafa Parsa
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9681944691
Phone
+98 51 5542 1977
Fax
Email
Nur.mostafa.parsa@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Questionnaire form and data analysis collected.
When the data will become available and for how long
Starting the access period year1402
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Statistical result.
From where data/document is obtainable
Zahedan University of Medical Sciences Library
Country Theses System
Researcher Gmail: Nur.mostafa.parsa@gmail.com
phone 09033321800
What processes are involved for a request to access data/document
With a written request to the Research Vice_Chancellor of Zahedan University of Medical