Determining the Effect of Stress Management Training on Stigma and Social Phobia of HIV Positive Women
Design
In this research, 60 women who have been diagnosed with the HIV virus have been selected and their illness confirmed by their medical records and they have been diagnosed 6 months. These women come to the Shohada Comprehensive Health Center in Hamedan for medical treatment. This is a quasi-experimental study that will be done in a single group before and after the intervention.
Settings and conduct
Research environment is Shohada Comprehensive Health Center in Hamedan city. 60 women with HIV are entered to study in the census method. Stress management training interval will be done on HIV women in a single group. Stigma and social phobia before and after intervention are evaluated by Berger's HIV stigma questionnaire and Canor's social phobia questionnaire.
Participants/Inclusion and exclusion criteria
Entrance criteria: The women with at least, 6 months of HIV infection; Having an active medical record; No history of psychiatric disorders associated; No history of physical and mental disabilities; The ability to read and write. Exit criteria: The absence more than two sessions at training sessions؛ Experience the stressful event during the study.
Intervention groups
The intervention group includes HIV positive women. The questionnaires will be completed by self-report before the intervention. Then the stress management training program is implemented in a group with a lecture method and the use of a poster and an educational booklet.
Main outcome variables
The Stress Management Training, Stigma, Social Phobia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171206037775N1
Registration date:2018-01-11, 1396/10/21
Registration timing:registered_while_recruiting
Last update:2018-01-11, 1396/10/21
Update count:0
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Neda Tahour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3838 0535
Email address
ne.tahoor@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-04-04, 1397/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Stress Management Training on Stigma and Social Phobia of HIV Positive Women
Public title
The Effect of Stress Management Training on HIV Positive Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least, 6 months of HIV infection
No history of psychiatric disorders associated
No history of physical and mental disabilities
The ability to read and write
Having an active medical record
Exclusion criteria:
The Absence more than two sessions at training sessions
Experience the stressful event during the study
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
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 Hamadan University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmide Bulv., Hamedan
City
Hamedan
Province
Hamadan
Postal code
65178
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.UMSHA.REC.1396.568
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
اچ آی وی
ICD-10 code description
اچ آی وی
Primary outcomes
1
Description
Stigma score in the stigma Berger's questionnaire
Timepoint
Before intervention and after 2 weeks
Method of measurement
Stigma Berger's questionnaire
2
Description
Social phobia score in the social phobia Canor's questionnaire
Timepoint
Before intervention and after 2 weeks
Method of measurement
Social phobia Canor's questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of HIV positive women that will be evaluate before intervention by pretest. Then the stress management training program is performed as a lecture, a poster, and a booklet in groups of ten. The number of training sessions is five and each week has a 45 to 60 minutes session that is held for each group. After two weeks of training, the post-test will be take.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Comprehensive Health Center
Full name of responsible person
Neda Tahour
Street address
Shohada Comprehensive Health Center, Takhti Ave., Hamedan
City
Hamedan
Province
Hamadan
Postal code
47584
Phone
+98 81 3252 0744
Email
ne.tahoor@edu.umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Vice chancellor for research, Hamadan University of Medical Sciences,Shahid Fahmideh Bulv., Hamedan
City
Hamedan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0320
Email
ne.tahoor@edu.umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Neda Tahour
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh Bulv., Hamedan
City
Hamedan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0320
Email
ne.tahoor@edu.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Neda Tahour
Position
Master student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh Bulv., Hamedan
City
Hamedan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0320
Email
ne.tahoor@edu.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Neda Tahour
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh Bulv., Hamedan
City
Hamedan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0320
Email
ne.tahoor@edu.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Presentation of thesis final report
When the data will become available and for how long
Second semester of 2018
To whom data/document is available
Faculty Members of Universities, Students, Health and Treatment Systems Managers, HIV Patients
Under which criteria data/document could be used
Educational planning, Consultation, Research
From where data/document is obtainable
Hamadan University of Medical Sciences
What processes are involved for a request to access data/document
Referring to Digital Library Website of Hamadan University of Medical Sciences