Determining the Effect of Counseling on Crisis Relationship Skills (Peirce Model) on Increasing Marital Satisfaction and Adoption of HIV-positive Women Referring to Imam Khomeini Hospital's Research Center for Behavioral Illnesses in Tehran
Design
In this research, 50 eligible patients referring to voluntary and counseling center for HIV. will chose purposefully and a code will allocate to each one of them. Then, patients randomly will divide into two control and intervention groups.block randomization and intervention is group counseling
Settings and conduct
En It is a randomized controlled clinical trial without blinding. setting and conduct: voluntary and counseling testing Center of Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Having minimum cycle education
• Having a regular sex partner
• Has a positive HIV partner
• The desire to attend training courses and the lack of individual counseling services outside of the sessions
• Complete the consent form for research
Exit criteria:
• Having a history of hospitalization in psychiatric hospitals
• Use of any psychoactive drugs
• alcohol consumption
• Cancellation and inability to complete sessions (no participation in two sessions)
• Get other psychological and counseling services
• Lack of sexual function based on the gender identity questionnaire score
Intervention groups
The intervention group received eight sessions of the class; the control group received a national protocol
Main outcome variables
satisfaction and material adjustment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160503027728N11
Registration date:2019-03-14, 1397/12/23
Registration timing:registered_while_recruiting
Last update:2019-03-14, 1397/12/23
Update count:0
Registration date
2019-03-14, 1397/12/23
Registrant information
Name
Zohreh Mahmoodi
Name of organization / entity
Nursing&Midwifery faculty
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
zohrehmahmoodi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-09, 1397/10/19
Expected recruitment end date
2019-07-10, 1398/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of an Intimate Relationship Skills Training (Pairs) on Marital Adjustment and Satisfaction In in Women with HIV positive
Public title
The Effectiveness of an Intimate Relationship Skills Training (Pairs) on Marital Adjustment and Satisfaction In in Women with HIV positivet
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
• Having a regular sex partner
Has a positive HIV partner
The desire to attend training courses and the lack of individual counseling services outside of the sessions
Complete the consent form for research
Having minimum cycle education
Exclusion criteria:
Having a history of hospitalization in psychiatric hospitals
Use of any psychoactive drugs
alcohol consumption
Cancellation and inability to complete sessions (no participation in two sessions)
Get other psychological and counseling services
Lack of sexual function based on the gender identity questionnaire score
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
En First, the sampling will be available and according to the active records in the center. Then they will be divided into two groups based on random blocks. Also for statistical matching, the statistical tests are used to match the underlying variables The randomization method is done using block randomization so that the sample size of both groups is equal.
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 committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, Shahrake Edari, North Taleghai square, Karaj, Iran
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.ABZUMS.REC.1397.196
Health conditions studied
1
Description of health condition studied
Human immunodeficiency virus
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Marital Satisfaction - Marital Compatibility
Timepoint
En Before intervention _ Immediately after the intervention -4 weeks after intervention
Method of measurement
Marital satisfaction questionnaire score and Marital adjustment questionnaire score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In this group, women with HIV live in addition to routine counseling centers, eight group training sessions are provided based on pairs model.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Imam khomani hospital volantary and counseling center
Full name of responsible person
Dr Zohreh Mahmoodi
Street address
The Department of Infectious and tropical Disease, Imam Khomeini Hospital, Keshavarz Blvd
City
tehran
Province
Tehran
Postal code
14-19-733141
Phone
+98 21 6658 1583
Email
zohrehmahmoodi2011@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
ِDr moohammad Noori sepehr
Street address
Noor street, Taleghani Square, Karaj
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3256 3328
Email
zohrehmahmoodi2011@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
En Alborz 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
Karaj University of Medical Sciences
Full name of responsible person
Zohreh Mahmoodi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Karaj-Meidan-e-Prophet-end of the West Buali-higher of the University of Arts-Campus University of Medical Sciences-Faculty of Medicine
City
karaj
Province
Alborz
Postal code
561-31452
Phone
+98 26 3428 7425
Email
zohrehmahmoodi2011@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Zohreh Mahmoodi
Position
pHD
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Karaj-Meidan-e-Prophet-end of the West Buali-higher of the University of Arts-Campus University of Medical Sciences-Faculty of Medicine
City
karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7425
Email
zohrehmahmoodi2011@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Zohreh Mahmoodi
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Karaj-Meidan-e-Prophet-end of the West Buali-higher of the University of Arts-Campus University of Medical Sciences-Faculty of Medicine
City
karaj
Province
Alborz
Postal code
561-31452
Phone
+98 26 3428 7425
Email
zohrehmahmoodi2011@gmail.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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The English version of the article entitled The Effect of Crisis Relationship Skills Counseling (Pierce's Model) on Marital Satisfaction and Adaptation in HIV-positive Women Referring to the Behavioral Disease Research Center of Tehran Imam Khomeini Hospital, Tehran, 1939-98, is published in the Journal of Prestige.
When the data will become available and for how long
En 10 month later
To whom data/document is available
En Iranian research center for HIV/AIDS , Alborz University of Medical Sciences
Under which criteria data/document could be used
En path analysis
From where data/document is obtainable
AIDS Research Center, Tehran University of Medical Sciences and Alborz Medical School
What processes are involved for a request to access data/document