Determining the effectiveness of group counseling based on the sexual health model on sexual anxiety and marital conflicts of women with HIV
Design
A semi-experimental study (pre-test, post-test) will be done conducted on Sexual Anxiety and Marital Conflicts of women with HIV. Sampling will be done by census method. The number of samples will be 34 people. The intervention includes the sexual health model with the participation of eligible women with HIV.
Settings and conduct
Counseling based on the Sexual Health Model on Sexual Anxiety and Marital Conflicts of women with HIV will be held in Yazd Center of Behavioral Diseases. Sampling will be done by census. The samples will be placed in groups of 11-12 people. The intervention will be carried out in 3 sessions of 90 minutes weekly and during 3 consecutive weeks. Questionnaires will be completed at baseline, at the end of the intervention and 4 weeks after the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion: Being Iranian, HIV infection based on the diagnosis of the Attending physician and the medical record at the Behavioral Disease Counseling Center of Yazd, Ability and interest to participate in counseling sessions, Having a common bed with a spouse. Exclusion: Pregnancy, having any severe mental or physical illness, Unwillingness to participate in the study.
Intervention groups
For intervention group, 3 90-minute sessions based on the Sexual Health Model, once a week in the Yazd Center of Behavioral Diseases will be held in person.
Main outcome variables
Change in Mean scores of Marital Conflicts and Sexual Anxiety.
General information
Reason for update
Acronym
SHM
IRCT registration information
IRCT registration number:IRCT20230110057094N1
Registration date:2023-02-02, 1401/11/13
Registration timing:prospective
Last update:2023-02-02, 1401/11/13
Update count:0
Registration date
2023-02-02, 1401/11/13
Registrant information
Name
Zahra Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3262 3638
Email address
z.ghasemi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-08, 1401/11/19
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of Sexual Health Model on Sexual Anxiety and Marital Conflicts of women with HIV
Public title
Investigating the effect of Sexual Health Model on Sexual Anxiety and Marital Conflicts
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
HIV infection based on the diagnosis of the attending physician and the medical record at the behavioral disease counseling center in Yazd
Ability and interest to participate in counseling sessions
Having a common bed with a spouse
Exclusion criteria:
Pregnancy
Having any severe mental or physical illness (Schizophrenia, cancer...)
Unwillingness to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar Square; Yazd
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.SSU.REC.1401.082
Health conditions studied
1
Description of health condition studied
Sexual anxiety counseling, Counseling of marital conflicts
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Changes in mean scores of marital conflicts among women with HIV
Timepoint
In the baseline, completion of the intervention (End of the third week) and in the follow-up period (4 weeks after the completion of the intervention)
Method of measurement
MCQ_R Marital conflicts questionnaire
Secondary outcomes
1
Description
Changes in mean sexual anxiety scores of women with HIV
Timepoint
In the baseline, completion of the intervention (End of the third week) and in the follow-up period (4 weeks after the completion of the intervention)
Method of measurement
Sexual anxiety questionnaire (Davis)
Intervention groups
1
Description
Intervention group: The intervention of sexual health model is done face-to-face in a group at Yazd center of behavioral diseases for 3 sessions of 90 minutes, once a week by the researcher. The content of the sessions includes: introduction of psychological education of sexual health model, Education about culture, gender and gender identity, anatomy and sexual function, Sexual health care and safer sex, challenges, barriers of health and body image, imagination and sexual fantasy, sexual desires, intimacy in the relationship, spirituality. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed and the assigned tasks related to the previous session will be reviewed by the researcher. Women are asked to participate in discussions and raise their questions. At the end of each session, a summary of the important topics discussed is presented and people's questions are answered, and women are asked to do their homework in the next sessions.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd center of behavioral diseases
Full name of responsible person
Mahshid Bokaie
Street address
Imam Jafar Sadiq Blvd
City
Yazd
Province
Yazd
Postal code
: 8916715171
Phone
+98 35 3624 1444
Email
mah_bokaie@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Moradi
Street address
Central Organization of Shahid Sadoughi University of Medical Sciences, Yazd, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
alirezampr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
mah_bokaie@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All individual data of study participants can be shared after de-identification.
When the data will become available and for how long
After results publication.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them.
Under which criteria data/document could be used
Scientific usage.
From where data/document is obtainable
mah_bokaie@yahoo.com
What processes are involved for a request to access data/document