To determine the effect of Tele-nursing on self-efficacy and sense of coherence of patients with ostomy attending Tehran Ostomy Association
Design
This study is a controlled randomized clinical trial in which the research sample were selected based on inclusion criteria and will be assigned to control (n=60) and intervention (n =60) groups through throwing coin.
Settings and conduct
Study place will be Tehran Ostomy Association. Patients in both intervention and control groups will enrolled immediately after receiving the usual education of the association and the demographic, self-efficacy and sense of coherence questionnaires will be filled through interview with patients. Then the intervention group will receive 6 phone calls (in the form of three calls in the first week, two calls in the second week and one call in the third and fourth weeks, and also sending an SMS before each call) during the follow-up period. A month after entering the study, the questionnaires will be filled again in both groups and the results will be analyzed using the spss statistical software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having at least one kind of ostomy; having at least 18 years of age, having the ability to read, write and answer the questions.
Intervention groups
Intervention group: In addition to the usual education of the Ostomy Association, tracking and training through telenursing will be done during a month in the form of three calls in the first week, two calls in the second week and one call in the third and fourth weeks, and also sending an SMS before each call.
Control group: they only will receive usual education of the Ostomy Association.
Main outcome variables
Improvement of the sense of coherence and self-efficacy in intervention group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161011030261N2
Registration date:2018-10-16, 1397/07/24
Registration timing:retrospective
Last update:2018-10-16, 1397/07/24
Update count:0
Registration date
2018-10-16, 1397/07/24
Registrant information
Name
Parisa Saeidi Ortakand
Name of organization / entity
Shahid Beheshti University of Medical Sciences & Heaith Services
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
parisa-saeidi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahidbeheshti University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2017-04-19, 1396/01/30
Trial completion date
empty
Scientific title
The effects of tele-nursing on self-efficacy and sense of coherence of patients with ostomy
Public title
The Effect of Tele_ Nursing on Self _ Efficacy and Sense of Coherence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 80 years
Maximum duration of having ostomy should be 60 days
having reading and writing abilities
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
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
The Ethics Committee, International Branch, Shahid Beheshti University Of Medical Sciences,
Street address
No19, beside Hemmat Bridge, Abbaspoor Street, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1434875451
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.248
Health conditions studied
1
Description of health condition studied
Ostomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self Efficacy
Timepoint
At the first time of coming to the association and one month later
Method of measurement
Self Efficacy Scale
Secondary outcomes
1
Description
Sense of Coherence
Timepoint
At the first time of coming to the association and one month later
Method of measurement
Sense of Coherence assessment tool
Intervention groups
1
Description
Intervention group: In addition to the usual education of the Ostomy Association, tracking and training through telenursing will be done during a month in the form of three calls in the first week, two calls in the second week and one call in the third and fourth weeks.
Category
Other
2
Description
Control group: usual education of the Ostomy Association will be done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Ostomy Association
Full name of responsible person
Dr Anaraki
Street address
No 6, Esmaeilzade Alishah Alley, Mirzaei Bighash Alley, Fatemi street.
City
Tehran
Province
Tehran
Postal code
1414
Phone
+98 21 8896 9602
Email
info@iranostomy.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahrokh Dolatian
Street address
at the beginning of Nyayesh highway, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Email
sbnmf@sbmu.ac.ir
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 Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Saeidi Ortakand
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Shahid Beheshti University of Medical Sciences, at the beginning of Nyayesh highway, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1968
Phone
+98 21 5536 9914
Fax
Email
parisa-saeidi@sbmu.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Camelia Rohani
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, at the beginning of Nyayesh highway, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1968
Phone
+98 21 8865 5366
Fax
Email
Camelliarohani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Saeidi Ortakand
Position
Master of Science student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Shahid Beheshti University of Medical Sciences, at the beginning of Nyayesh highway, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1968
Phone
+98 21 5536 9914
Fax
Email
Parisa-saeidi@sbmu.ac.ir
Web page address
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
The data will not be published and will be reserved and won't be disseminated. If necessary other researchers will be referred to the authors.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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