The aim of this study is determine of self-care education program effect on Quality of Life and Stress in intestinal ostomy patients . The study population of 76 patients with intestinal ostomy referred to clinics of colorectal in Hazrat e Rasool and firoozgar hospitals that have inclusion criteria . Method sampling will be continuously . On the stage before the completion of the questionnaire will attending the intervention was for that time completion will be 15-20 minutes and then compile self education program for educational booklet and pamphlet about intestinal ostomy diseases , ostomy late complications and etc . Will performed in three one-hour sessions during the three weeks for the test group . The team training will be consists of a group of 8 to 10 people. During the study all subjects will receive standard care . Quality of life and stress test and control groups , in before the process of self-care education and 2 months after the training, by Perceived Stress Scale (PSS-14) and the City of Hope Quality of Life Ostomy patients questionnaire (COH-QOL) will be measured and in the end the amount of stress and quality of life of the two groups will be evaluated .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070428781N1
Registration date:2016-10-21, 1395/07/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-21, 1395/07/30
Registrant information
Name
Farshad Heidari Beni
Name of organization / entity
Iran Univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 38 3372 3354
Email address
heydari-bani.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research funding of Iran University of medical sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of self-care education program effect on Quality of Life and Stress in intestinal ostomy patients
Public title
The effect of education on quality of life and stress in patients with intestinal stoma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria were: having a permanent or temporary intestinal stomy , be at least 18 years old , be have mental disorder , speech , vision and hearing and the delicate hand movements based health records and physician's instructions (such as arthritis rheumatoid and physical illnesses of the upper limb), Passed at least one month from the time of surgery , the ability to speak the Persian language , read and write. Exclusion criteria : Lack of patient satisfaction from participating in continuing research , death of the patient , absent in one education session , the occurrence of any complication or severe disability while performing the study .
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Ethic committee of Iran University Of Medical Sience
Street address
Iran University of Medical Sciences ,Hemat Highway
City
tehran
Postal code
Approval date
2016-04-05, 1395/01/17
Ethics committee reference number
IR.IUMS.REC.1394.9211196235
Health conditions studied
1
Description of health condition studied
gastrointestinal cancer
ICD-10 code
C26.9
ICD-10 code description
Ill-defined sites within the digestive system
Primary outcomes
1
Description
Quality of life for people with ostomy
Timepoint
At beginning and two months after completion of the intervention
Method of measurement
City of Hope-Quality of Life-Ostomy Questionnaire(COH-QOL)
Secondary outcomes
1
Description
Stress
Timepoint
At beginning and two months after completion of the intervention
Method of measurement
Perceived Stress Scale (PSS-14)
Intervention groups
1
Description
The test group will be divided into groups of 8 to 10 people . After the compilation of self-care education program in accordance with the opinion of the supervisor for educational booklet and pamphlet about intestinal ostomy diseases , ostomy late complications , nutrition , exercise , training , and advice about the care of the skin around the stoma will performed in three one-hour sessions during the three weeks for the test group . Training sessions to lecture , group discussion with the use of slides and training booklet will be administered . Educational sessions , training as much as possible in the form of a simple , perceptible without the use of specialized terminology and medicine will be presented . After the completion of educational intervention to the post test phase will be asked of the people group intervention that education program at the time of their presence in home to be operated .
Category
Lifestyle
2
Description
The control patients will receive standard hospital care
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat e Rasool Hospital
Full name of responsible person
Mojtaba Zibadi
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mojtaba Zibadi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Room #503, 5th floor, Central building of Iran University of Medical Sciences, between Chamran and Hemmat Expways, Hemmat Expway
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Zibadi
Position
Nursing Msc Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery , No 6 , Rashid Yasemi st , Vali-e-asr Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 1880
Fax
Email
mojtaba.zibadi2015@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Fariba Nasiri Ziba
Position
Educator
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Iran University of Medical Sciences , No 6 , Rashid Yasemi st , Vali-e-asr Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 1880
Fax
Email
fariba_nz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Zibadi
Position
Nursing Msc Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Iran University of Medical Sciences , No 6 , Rashid Yasemi st , Vali-e-asr Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 1880
Fax
Email
mojtaba.zibadi2015@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)