Comparison of the effect of face to face and multimedia education on the adaptation and anxiety of people wit intestinal stoma
Design
Three groups randomized clinical trial
Settings and conduct
The present study is a randomized clinical trial study. Total of 126 individuals with intestinal stoma by available sampling will be choose. The research population is people who will be admitted to two selected hospitals of Iran and Tehran Medical Sciences Universities. Th Data collection tools included a demographic questionnaire and a questionnaire on adjustment and anxiety of people with intestinal stoma. Control group will be take routine care. Face-to-face group members will be educated individually in the hospital environment during three consecutive sessions in three consecutive days. To the people of the multimedia group, using the laptop will be taught how to use multi-media software individually. They will also be given a software and guide to using the software, and will answer the patient's questions at the end of the session. Three months after discharge questionnaires will be completed by the patients in all three groups, and at the same time.
Participants/Inclusion and exclusion criteria
Having intestinal stoma (permanent or temporary)
Being aged between 70 and 18 years old
Having reading and writing skills
Ability to work with the computer by the patient or with the help of the family
Having mental , speech, vision and hearing health(according to the patient)
The absence of physical and mental disabilities such as diabetes, cirrhosis, cardiovascular disease, depression, and .....
Intervention groups
Control group: taking routine care
Face-to-face education group: taking individualized and face-to-face education related to illness
Multimedia education group: taking education related to illness using multimedia software
Main outcome variables
Adaptation
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091124002769N7
Registration date:2018-09-18, 1397/06/27
Registration timing:registered_while_recruiting
Last update:2018-09-18, 1397/06/27
Update count:0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Mansoureh Ashghaly Farahani
Name of organization / entity
Iran University Medical Sciences ,Nursing & Miwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1615
Email address
farahani.ma@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of face to face and multimedia education on the adaptation and anxiety of People with intestinal stoma
Public title
comparison of Face-to-face and multimedia education on the adaptation and anxiety of People with intestinal stoma
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
(Having intestinal stoma (permanent or temporary
Having ages between 70 - 18 years
Having reading and writing skills
Ability to work with the computer by the patient or with the help of the family
Having mental, speech, vision and hearing health (according to )the patient
Exclusion criteria:
The presence of physical and psychological disabilities such as: diabetes, cirrhosis, cardiovascular disease, depression, and .....
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning samples to the groups is random block type triplex without permutation (21 blocks of 6 of 126 modes) from each center.In this sampling method, different modes of the three groups using the random numbers table are written on six cards, each put into an closed package. These packages are placed in a box and the researcher does not know which samples of research will be selected before choosing the car. The statistician (unaware of the study and the groups) with the choosing one of the packages from the box, determines which of the three patients entered to the study will fall into the which category, respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran Medical Sciences University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1996713833
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.IUMS.REC 1396.32780
Health conditions studied
1
Description of health condition studied
Intestinal Stoma
ICD-10 code
Z93.3
ICD-10 code description
Colostomy status
Primary outcomes
1
Description
Adjustment - Adjustment Score from Ostomy Adjustment Inventory
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Ostomy Adjustment Inventory
Secondary outcomes
1
Description
Anxiety - Anxiety score from Spielberger questionnaire
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Spielberger questionnaire
Intervention groups
1
Description
Intervention group: Face-to-face education: Individually will be educated in the hospital environment and during three consecutive session in three consecutive days.
Category
Rehabilitation
2
Description
Intervention group: Multimedia education group: At the time of discharging, the CD will be given to patients in this group to use at home. Using laptops, the use of multimedia software will be taught individually.
Category
Rehabilitation
3
Description
Control group: Control group: Taking routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Farshad Heidari
Street address
Emam Khomeini Hospital, Keshavarz blv, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1615
Email
heidarifarshad70@yahoo.com
2
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Farshad Heidari
Street address
Rasoul Akram Hospital, Niyayesh St, Sattarkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
heidarifarshad70@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakooti
Street address
Room #503, 5th floor, Central building of Iran University of Medical Sciences, between Chamran and Hemmat Expways, Hemmat Expway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
heidarifarshad70@yahoo.com
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
Mansoureh Farahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, No 6 , Rashid Yasemi st, Vali-e-asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
m_negar110@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mansoureh Farahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, No 6, Rashid Yasemi st, Vali-e-asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
m_negar110@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mansoureh Farahani
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, No 6, Rashid Yasemi st, Vali-e-asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713833
Phone
+98 214365100
Email
m_negar110@yahoo.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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be shared after unidentifiable people
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
Anyone ask for it, the data will be sent to them
Under which criteria data/document could be used
Any use of the documentation is allowed
From where data/document is obtainable
Dr Mansoureh Farahani- School of Nursing and Midwifery , No 6 , Rashid Yasemi st , Vali-e-asr Ave , Tehran, Iran
0098 21 43651000
What processes are involved for a request to access data/document
The request is submitted in writing or verbally, and then the data will be sent in 1 month