This study is a Randomized Clinical Trial study with two arms. The goal is to determine the effect of an educational program on severity of symptoms and quality of life. The study population includes patients with IBS who have been referred to specialist clinic in Arak. Inclusion criteria: age 18-65 years old; be able to read Persian; having the sign and symptom of Rome III ; mild till moderate diagnosis of IBS. Exclusion criteria: diagnosis of any other disease during study which have signs and symptoms similar to IBS; not cooperative patient. There were two intervention and control groups. Subjects were allocated to the groups randomly. the sample was 44 patients in each group and attrition rate of 10 %. which was calculated based on specific formula and on the whole 100 patients were recruited for both groups. All participants signed an informed consent. Both groups will receive the treatment for IBS but the intervention group will receive the educational program and the quality of life and the severity of sign and symptoms will be measured by standard instruments in two phases before giving and 8 weeks after giving education (IBS-QOL & IBS-SSS) in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310195987N7
Registration date:2014-01-20, 1392/10/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-20, 1392/10/30
Registrant information
Name
Shahrzad Ghiyasvandian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shghiyas@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of instructional program of self-care on severity of symptoms and quality of life in patients with irritable bowel syndrom
Public title
The effect of instructional program of self-care on severity of symptoms and quality of life in patients with irritable bowel syndrom
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18-65 years old; be able to read persian; having the sign and symptom of Rome III ; mild till moderate diagnosis of IBS. Exclusion criteria: Determining any disease during study which sign and symptoms are similar to IBS; not cooperative patient.
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:
100
Randomization (investigator's opinion)
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
Ethics Commitee of Tehran University Medical Science
Street address
6th floor, Tehran University of Medical Sciences' central building, Ghods St., Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2013-10-22, 1392/07/30
Ethics committee reference number
130/1554/د/92
Health conditions studied
1
Description of health condition studied
Irritable Bowel Syndrom
ICD-10 code
K58
ICD-10 code description
irritable colon
Primary outcomes
1
Description
The severity of symptoms of IBS
Timepoint
Before and 8 weeks after RCT
Method of measurement
IBS-SSS
2
Description
The quality of life of patients with IBS
Timepoint
Before and 8 weeks after RCT
Method of measurement
IBS-QOL
Secondary outcomes
empty
Intervention groups
1
Description
The case group: giving educational package to patients which contains a booklet of IBS and a relaxation CD. The education will be given during an individual meeting, two telephone calls and a group meeting.
Category
Other
2
Description
The control group: will receive the treatment of IBS.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal Specialist Clinic
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masod Yonesian
Street address
6th floor, Tehran University of Medical Sciences' central building, Ghods St., Keshavarz Boulevard
City
Tehran
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, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Scienses
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of nursing & midwifery ,Tohid Square
City
Tehran
Postal code
Phone
+98 21 6642 0739
Fax
Email
shghiyas@tums.ac.ir; shghiyas@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Scienses
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of nursing & midwifery ,Tohid Square
City
Tehran
Postal code
Phone
+98 21 6642 0739
Fax
Email
shghiayas@tums.ac.ir; shghiyas@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Scienses
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of nursing & midwifery ,Tohid Square
City
Tehran
Postal code
Phone
+98 21 6642 0739
Fax
Email
shghiyas@tums.ac.ir; shghiyas@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)