Effect the program of mindfulness based stress reduction on HIV-Positive Women's resilience
Design
The study is a clinical trial study.90 positive HIV patients are selected by available sampling method from persons who had medical records at Imam Khomeini Hospital Counseling Center for Behavioral Diseases, by referring to Tehran's Imam Khomeini Hospital Counseling Center of Behavioral Diseases. without blinding,sampling is done randomely,both groups completed the resilince questionnaire and then the subjects in the intervention group participated in 8 sessions of 60 minutes each week and undergo training. Then immediately after the end of the sessions, and then 4 weeks after the intervention, the resilience questionnaire is again completed.
Settings and conduct
AIDS Reasearch Center and Behavioral Disease Counseling Center located in Imam Khomeini Hospital where participants are randomly selected
Participants/Inclusion and exclusion criteria
Inclusion criteria:informed consent,age range of 15-45 years,reading and writing literacy,diagnosis of HIVover 6 months,being Iranian,physical and mental health sufficient to participate in study,lack of participation in educational classes focusing on MFand stress management,lack of chronic diseases and known chronic psychiatric disorders and problems and exit criterion is unwillingness to continue cooperation
Intervention groups
Entervention group:45 HIV posetive woman15-45years old who are referred to the AIDS Resarch Center and Conseling Center forBehavioral Diseases at Imam Khomeini with Written consent,and tendency to participate in the study and recieve rducational intervention Mindfulness Based Stress Reduction Program.control group:45 HIV posetive woman15-45 years old who are referred to the same center but do not receive any fducational intervention.
Main outcome variables
Education Mindfulness Based Stress Reduction Program,resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120414009463N59
Registration date:2019-04-29, 1398/02/09
Registration timing:prospective
Last update:2019-04-29, 1398/02/09
Update count:0
Registration date
2019-04-29, 1398/02/09
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mindfulness Based Stress Reduction Program on HIV-Positive Women's Resilence
Public title
The Effect of Mindfulness Based Stress Reduction Program on Resilience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent for participation in the study
Age range of 15-45 years
Reading and writing literacy
Diagnosis of HIV over 6 months
Being Iranian
Physical and mental health sufficient to participate in this study
Lack of participation in educational classes focusing on mindfulness and stress management
Lack of chronic diseases and known chronic psychiatric disorders and problems
Exclusion criteria:
Unwillingness to continue cooperation
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be selected by simple random sampling using random numbers table will be assinged to two groups of intervention and control.which will be considered after determining how to read the table numbers.odd numbers for the control group and the even numbers for the intervention group.
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
The ethics Commitee of the Faculty of Nursing and Midwifery,Tehran University of Medical Science
Street address
PO Box 6459,Dr Mirkhani St.(Eastern Nusrat),Tohid Square
City
Tehran
Province
Tehran
Postal code
6459
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.TUMS.FNM.REC.1397.213
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
B20.3
ICD-10 code description
HIV disease resulting in other viral infections
Primary outcomes
1
Description
Resilience
Timepoint
Before the intervention,immediately after the end of the sessions and 4weeks after intervention
Method of measurement
Using standard rsilience questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: participated in 8 sessions of 60 minutes each week and undergo training. Then immediately after the end of the sessions, and then 4 weeks after the intervention, the resilience questionnaire is again completed.
Category
Other
2
Description
Control group:In the control group ,intervention is not performed,and only after completing the study for observance of the ethics training book will be provided to the control group after the end of intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Reasearch Center for HIV/AIDS and Voluntary Conselling and Testing (VCT) center of Imam Khom
Full name of responsible person
Minoo Mohraz
Street address
Iranian Research Center for HIV/AIDS, Imam Hospital .Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8566 3851
Fax
+98 21 4966 4897
Email
irch@sina.tums.ac.ir
Web page address
http://ircha.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr,mohamad Ali Sahraeian
Street address
No23,Valiasr Avenue,Dameshgh Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 3618 5863
Fax
+98 21 3618 5863
Email
narges.3161396@gmail.com
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr.Zahra Behboodi Moghadam
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing and Midwifery Faculty,Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2966 1717
Fax
+98 21 4252 6690
Email
Behboodi@tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Behboodi Moghadam
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing and Midwifery Faculty,Tehran University of Medical Sciences,East Nosrat Avenue.Towhid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2966 1717
Fax
+98 21 4252 6690
Email
Behboodi@tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narjes Aghaie
Position
Master of Midwifery Student Reproductive Health
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan 2,Tehran University of Medical Science dormitory ,North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 21 8801 6073
Fax
+98 21 8863 0021
Email
narges.3161396@gmail.com
Web page address
https://eskan.tums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available