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The Effect of self care education on self-efficacy and life style of patients with an intestinal ostoma

Protocol summary

Study aim
Determining the effect of self-care education on self-efficacy and lifestyle of people with gastrointestinal ostomy
Design
A clinical trial with a control group with parallel groups, randomized on 74 patients. Random number table was used for randomization.
Settings and conduct
After completing the pre-test, all individuals who met the inclusion criteria were divided into two groups of intervention and control after completing the informed consent form using a random number table. The pre-test, which includes a personal information questionnaire, self-efficacy questionnaire and lifestyle questionnaire, was completed in both groups. Then, based on the self-care needs of these individuals, face-to-face training sessions were conducted in the intervention group using booklets and lectures in four 45-minute sessions. The control group received routine training of hospital staff. After 50 days, the subjects completed the questionnaires again.
Participants/Inclusion and exclusion criteria
Anyone who has a gastrointestinal ostomy and one month has passed since their ostomy was implanted, and is able to read, write and communicate, and does not have a mental disorder, can be included in the study.
Intervention groups
After the subjects were divided into intervention and control groups, the pretest, which includes a personal information questionnaire, self-efficacy questionnaire and lifestyle questionnaire, was completed in both groups. Then, based on the self-care needs of these people, face-to-face training sessions were conducted in the intervention group using booklets and lectures in four 45-minute sessions. The control group received routine training of hospital staff. After 50 days, the subjects completed the questionnaires again.
Main outcome variables
Self-care, Self-efficacy, life style

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200708048061N1
Registration date: 2020-12-06, 1399/09/16
Registration timing: retrospective

Last update: 2020-12-06, 1399/09/16
Update count: 0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
Fatemeh Yousefli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5564 5378
Email address
yousefli.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-04-20, 1399/02/01
Trial completion date
2020-05-25, 1399/03/05
Scientific title
The Effect of self care education on self-efficacy and life style of patients with an intestinal ostoma
Public title
Investigating theeffect of training on self-efficacy and lifestyle of ostomates
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least one month after ostomy implanation Age between 18-65 Literacy for reading and writing Lack of psychiatric disorders Failure to attend self-care training sessions in the last six month Ability to communicate Ability to collaborate
Exclusion criteria:
Withdrawal from continuing research Absence in two sessions of training sessions Participate in self-care training sessions while participating in research
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: 74
Actual sample size reached: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be continuous at the sample section stage and then a simple random method will be used to distribute the samples to the intervention and control groups. The samples will be distributed to two groups of intervention and control by a third party who is unaware of the study flow using the table of random numbers.
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 in Biomedical Research
Street address
Ebne Sina Hospital, The beginning of Ayatollah Kashani Highway
City
Tehran
Province
Tehran
Postal code
71348-14336
Approval date
2019-05-22, 1398/03/01
Ethics committee reference number
IR.IUMS.REC.1398.167

Health conditions studied

1

Description of health condition studied
Patient with gastrointestinal ostomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Ostomy self-efficacy score higher than 42
Timepoint
Measurement of self-efficacy level before intervention and 50 days after
Method of measurement
How to measure the self-efficacy variable is the ostomy self-efficacy questionnaire.

2

Description
Lifestyle score above 140
Timepoint
Measuring lifestyle level before the medal and 50 days later
Method of measurement
General Lifestyle Questionnaire

Secondary outcomes

1

Description
This study has no secondary outcome variables.
Timepoint
This study has no secondary outcome variables.
Method of measurement
This study has no secondary outcome variables.

Intervention groups

1

Description
Intervention group: The samples will be distributed to the intervention and control groups by a third person who is unaware of the study using a random number table. The pre-test in the intervention group will include lifestyle tools and ostomy self-efficacy tools. Then, based on the educational needs of the patients under study and in accordance with these needs, a face-to-face training program using an educational booklet and lectures in the field (ostomy care, skin care around the ostomy, bag replacement, diet, activity and exercise, sexual activity, Travel, bathing and swimming).The training program will be done in 4 sessions of 45 minutes. After the training sessions, the educational content will be followed up by the researcher by phone every 15 days. After 50 days, the samples will be re-completed at the medical centers and the completed tools will be re-tested as a pre-test.
Category
Other

2

Description
Control group: The control group will receive routine training by medical staff at the same time as the pre-test group. In the control group, routine hospital follow-ups will be performed. After 50 days in the control group, a post-test is taken and finally the educational booklet is delivered to this group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Educational and Medical Center
Full name of responsible person
Fatemeh Yousefli
Street address
Rasoul Akram Hospital., corner of Mansouri St., Niayesh St.,Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
rasoolhospital@tums.ac.ir

2

Recruitment center
Name of recruitment center
Firoozgar Educational and Medical Center
Full name of responsible person
Fatemeh Yousefli
Street address
Firoozgar Hospital., Beh Afarin St., Karim Khan Zand St.,Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motavlian
Street address
Iran University of Medical Sciences., next to Milad Tower., Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Yousefli
Position
Master student of Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne Sina Hospital, at the beginning of Ayatollah Kashani Highway, Sadeghieh 2nd Square
City
Tehran
Province
Tehran
Postal code
1481795693
Phone
+98 21 4790 1133
Email
fatemeh.yousefli711116@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Nasiri Ziba
Position
Faculty of Nursing, Internal Surgery Field
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Iranian School of Nursing and Midwifery., Rashid Yasemi St., Above Vanak Sq., Valiasr St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
fariba_nz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Yousefli
Position
Master student of Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebne Sina Hospital, at the beginning of Ayatollah Kashani Highway., Sadeghieh 2nd Square
City
Tehran
Province
Tehran
Postal code
1481795693
Phone
+98 21 4790 1133
Email
fatemeh.yousefli711116@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
Not applicable
Analytic Code
Not applicable
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
Some of the unidentifiable information is the data that can be shared after the end of the study.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The documentation can only be used for review in research.
From where data/document is obtainable
Fatemeh Yousefli Phone number 09369903979 Email adress: fatemeh.yousefli711116@gmail.com
What processes are involved for a request to access data/document
After the applicant's request via email, the request will be submitted to the tutor and if she agrees, the request data will be sent via email.
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