Determination of the effect of bowel management program on the quality of life of children with fecal incontinence in Mofid children hospital of Shahid Beheshti University of Medical Sciences
Design
Clinical trial with control group
Settings and conduct
Obtaining permission from the Ethics Committee
Receive written consent from the helpful authorities
Identify eligible children
Introduce yourself and express the purpose of the research to children and their parents
Putting them randomly in the intervention and control group
Written Consent
Completion of children's quality of life questionnaire
Run intestinal management training program in seven days
A month later, a re-examination and completion of the QOL of the child
Participants/Inclusion and exclusion criteria
- Involve in research.
- Between the ages of 4 and 16.
- A definitive diagnosis of stool incontinence by the surgeon.
- Be able to understand Persian language
Intervention groups
In this research, children were selected through goal-based sampling and according to the criteria for entering the study, and then randomly divided into two groups of intervention and control.
The intervention will be the same as the training of the intestinal management program within a week that will be conducted orally and accompanied by educational pamphlets.
Main outcome variables
quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181113041644N1
Registration date:2018-12-12, 1397/09/21
Registration timing:prospective
Last update:2018-12-12, 1397/09/21
Update count:0
Registration date
2018-12-12, 1397/09/21
Registrant information
Name
Shiva Hojjati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3314 1838
Email address
shivahojjati@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing Effects of Educating Bowel Management Program On Quality Of Life In Children With Fecal Incontinence at Mofid hospital
Public title
Assessing Effects of Educating Bowel Management Program On Quality Of Life In Children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
their willingness to participate in research
Between the ages of 4 and 16
A definitive diagnosis of incontinence by surgery
Be able to understand Persian language
Exclusion criteria:
The caretakers are constantly changing
In a family, there is no other child with chronic illness.
Age
From 4 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Children who come to a Mofid hospital clinic are selected by specialist confirmation and divided into two intervention and control groups according to their file number in the way that the odd numbers become the intervention group. We do not have blindness in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-11-15, 1397/08/24
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.150
Health conditions studied
1
Description of health condition studied
Fecal incontinence
ICD-10 code
R15
ICD-10 code description
Fecal incontinence
2
Description of health condition studied
Patients with fecal incontinence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
quality of life
Timepoint
Measurement of quality of life before intervention and one month after the end of intervention
Method of measurement
Using the quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children who are referred to us by a specialist from the clinic and have an odd file number will be assessed by a pediatrician and nurse then the education program starts. the education program will be as follows: The first session will be orientation. The student will communicate with them by introducing themselves and asking questions such as the name and surname of the children. The student will explain the purpose of the research and the method of intervention to be completely clear to children and their parents. After obtaining written consent from the children and their parents, complete examination of the patient by examining the pattern and frequency of excretion and consistency and form of the stool, the study of diet and fluid intake, behavioral examination and abnormal habits and examination of the abdomen and perinea in cooperation with the physician. The quality of life questionnaire will then be provided to their parents during the same session to complete and deliver them during the same session or next meeting. At the next session on the second day, the curriculum will be performed on the basis of a survey conducted individually and within an hour, as well as a presentation of the pamphlet, and will be evaluated with questions from them and, if necessary, will be repeated again and will be available to all Questions for the child and parents will also be answered. In the next sessions that are on a daily basis, the child will first have a graph for the assessment of the bowel and, according to the physician's permission, the training program will continue or change, in which case the training will be carried out again by the nurse. . And by asking questions, the performance of the program is evaluated by him. Finally, on the seventh day, the final program of the gut management will be described and will be explained to the child and parents, and they will be asked to come back to the clinic one month later to re-examine and complete the quality of life questionnaire in the clinic. Tracking will be done by the student. During this time, the researcher's contact number will be provided to answer questions in the morning shift
Category
Other
2
Description
Control group: who receives even file number receives routine care and does not additional work for them anymore.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children's hospital
Full name of responsible person
Dr. Iman Zadeh
Street address
Shariati street
City
Tehran
Province
Tehran
Postal code
15514- 15468
Phone
+98 21 2222 7021
Fax
+98 21 2222 0254
Email
info-mch@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahrokh Dolatian
Street address
Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
mhdolatian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
1
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Hojjati
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 217088655366
Email
shivahojjati@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Hojjati
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.56. madani6 . valfajr. tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 3314 1838
Fax
Email
shivahojjati@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shiva Hojjati
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 217088655366
Email
shivahojjati@yahoo.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
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available