Protocol summary

Study aim
General purpose: Determining the effectiveness of self-care skills training on self-esteem and quality of life in children aged 12-8 years with ostoma in Tehran hospitals in 1395 Dedicated purposes: 1.Determine the self-esteem level of children aged 12-8 years with ostoma, before, immediately and one month after intervention in the case and control group 2.Determination of the quality of life of children aged 12-8 years with ostoma, before, immediately and one month after intervention in the case and control group 3.Compare the rate of self-esteem level of children aged 12-8 years with ostoma, before, immediately and one month after intervention in the case and control group 4.Compare the rate of quality of life level of children aged 12-8 years with ostoma, before, immediately and one month after intervention in the case and control group
Design
The research is a clinical trial with community-based and pragmatic control group, with parallel and randomized groups. A total of 36 samples were randomly divided into two groups (case and control) of 18 patients according to the patient's case number
Settings and conduct
This research was conducted in Tehran hospitals in 1395-1396. Having received the code of the Ethics Committee (1395.233) and the introductory letter, the researcher presented to the selected centers. In three working sessions, after obtaining written consent from the parents of children, demographic questionnaires, Cooper Smith's self-esteem and Kindle Life Quality by two The case and control groups were completed and then were trained in 6 sessions in the case group with self-care training stoma. The data were collected using a questionnaire completed three times before, after and one month after the intervention
Participants/Inclusion and exclusion criteria
Participants of the study, 36 children aged 8-12 years with stoma were randomly assigned to two groups of 18 patients based on case number. Entry criteria: • Children aged under 12 and over 8 years old. • Samples have not recently participated in courses on self-care skills in the field of stoma. • According to parents, there is no illness, physical disability, mental retardation or other behavioral disorder. • Have informed consent to participate in the study Exit criteria: Children who had absent more than two sessions
Intervention groups
Intervention in this study was the teaching of self-care skills in the field of stoma. The participants of the study, 36 children aged8 to 12 years old with stoma, were divided into two groups of 18 case and control. The case group was trained in 6 sessions of 45 minutes with the Stoma self-care training package (film and pamphlet)
Main outcome variables
quality of life, self-steem, self-care skills

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160802029166N2
Registration date: 2018-04-19, 1397/01/30
Registration timing: retrospective

Last update: 2018-04-19, 1397/01/30
Update count: 0
Registration date
2018-04-19, 1397/01/30
Registrant information
Name
nazanin shahedijoghan
Name of organization / entity
shahidbeheshtiuniversity
Country
Iran (Islamic Republic of)
Phone
+98 21 3375 6046
Email address
shahedi2011@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
20,000,000Rials
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
1986-08-23, 1365/06/01
Actual recruitment end date
2017-09-23, 1396/07/01
Trial completion date
empty
Scientific title
The Effectiveness of Self-Care Skills Training on Self-Esteem and Quality of Life in 8-12 Year Old Children with Stoma of Hospitals in Tehran in 1395
Public title
The Effectiveness of self-care skills training on self-esteem and quality of life in children with stoma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children under the age of 12 and over 8 years old Samples have not recently participated in ostoma self-care training courses Parents said that they have no illness, physical disability, mental retardation or other behavioral disorder Conscious informed consent to participate in the study
Exclusion criteria:
Children who had absent more than two sessions Individuals who participated in self-care sessions at the same time in the field of stoma.
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Sample file number was written on small paper and was packed in a packet and 18 case files were randomly selected as case group and 18 were randomly assigned to the control 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
College of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences and Health Services
Street address
Tehran, Valiasr Ave., Shahid Abbaspour Street, next to Paul Hemmat, No. 19
City
tehran
Province
Tehran
Postal code
ib@sbmu.ac.ir
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.233

Health conditions studied

1

Description of health condition studied
Hirschsprung disease
ICD-10 code
Q43.1
ICD-10 code description
Hirschsprung's disease

2

Description of health condition studied
Other congenital functional disorders of colon
ICD-10 code
Q43.2
ICD-10 code description
Other congenital functional disorders of colon

3

Description of health condition studied
Other congenital malformations of bladder and urethra
ICD-10 code
Q64.7
ICD-10 code description
Other congenital malformations of bladder and urethra

Primary outcomes

1

Description
Quality of Life
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Kindle Children's Quality of Life Questionnaire

2

Description
Self esteem
Timepoint
Pre-intervention, immediately and one month after intervention
Method of measurement
Cooper Smith Self-Esteem Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention as self-care skills training sessions including referral, familiarity with osteoporosis, exchange of colostomy bag, diet in osteoporosis patients, exercise and daily activity, and practical evaluation of interventional group for replacing osteoarthritis in 6 training sessions of 45 minutes prior to Surgery was conducted with pamphlets and educational videos
Category
Lifestyle

2

Description
Control group: The control group consisted of 18 children with ostoma (8-12 years old) admitted to selected hospitals in Tehran who did not receive any training on self care skills.
Category
N/A

3

Description
Intervention group: The intervention group consisted of 18 children with ostoma (8-12 years old) admitted to selected hospitals in Tehran who were trained in self-care skills in 6 sessions of 45 minutes (familiarity with ostoma, how to exchange colostomy bag, diet in ostomates, exercise and Daily activities)
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
mofid hospital
Full name of responsible person
Maryam Momeni
Street address
Mofid hospital,before Mirdamad Street, above Hosseiniyeh Ershad, Dr. Ali Shariati Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15514.15468
Email
info-mch@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mohammad Aqajani
Street address
Tehran - Shahid Chamran Highway - Yemen Ave. - Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1983969411
Email
pr.office@mail.sbu.ac.ir
Grant name
Grant code / Reference number
IR.SBMU.RETECH.REC.1395.233
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences and Health Services
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
Self-governing pardis of Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Nazanin Shahedi Joghan
Position
Bachelor of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Street address
Tehran, Rey city, Dolat Abad First Colloq, Ahmad Ali Nawaz St, Hasan Hassanzadeh Plain No. 13
City
Rey
Province
Tehran
Postal code
18578-87137
Phone
+213 3756046
Fax
Email
shahedi2011@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Dr. Jamile Mohtashami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Tehran - Vale Asr Ave. - Intersection of Prayer - In front of Shahid Rajaee Heart Hospital - Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+218 865536671
Fax
+98 21 8820 2521
Email
jmohtashami@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Nazanin Shahedi Jooghan
Position
Head Nurse
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
N13.hasan zade.Ali Navaz street.Rey city. Tehran
City
Rey city
Province
Tehran
Postal code
18578-87137
Phone
+213 3756046
Fax
Email
shahedi2011@yahoo.com
Web page address

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
Not applicable
Data Dictionary
No - There is not a plan to make this available
Loading...