Determining the effect of mindfulness counseling on sexual self-efficacy of HIV positive women in Ahvaz
Design
The clinical trial has two groups of control and intervention, randomized by permutation block method on 66 patients.
Settings and conduct
The sample of HIV-positive women referred to the High-Risk Diseases Center of Ahvaz, who were selected from the research community and have low sexual self-efficacy, the total number of participants is 60, which is 30 people in each group. The intervention is performed as a pre-test, post-test and follow-up stage so that the intervention group at the beginning of the study, week 8 and week 12 after the intervention complete the sexual self-efficacy questionnaire as a self-report. The control group despite low sexual self-efficacy They do not receive any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married age 25-45, possibility of continuous participation in training sessions, women whose sexual self-efficacy score is between 0 and 10;Exclusion criteria: use of drugs that affect sexual function, the patient's spouse has a sexual dysfunction, physical and other acute illnesses, simultaneous use of counseling and other educational services to increase sexual self-efficacy.
Intervention groups
The intervention group includes HIV-positive women with low sexual self-efficacy who are divided into three treatment groups of 7, during 8 sessions of group counseling (one session per week), with a mindfulness-based cognitive therapy approach to improve sexual self-efficacy. The control group consisted of 30 HIV-positive women with low sexual self-efficacy who did not receive any intervention.
Main outcome variables
Sexual self-efficacy; Readiness for sex; Self-stimulation; Communication without intimacy; Orgasm
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210317050736N1
Registration date:2021-04-27, 1400/02/07
Registration timing:prospective
Last update:2021-04-27, 1400/02/07
Update count:0
Registration date
2021-04-27, 1400/02/07
Registrant information
Name
Bahareh sadeghian Dastjerdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3338 9259
Email address
bahar.sadeghian@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-07-27, 1400/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness counseling on sexual self-efficacy of HIV positive women
Public title
The effect of mindfulness counseling on sexual self-efficacy of HIV positive women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25-45 years
Married
Have a minimum literacy
Have a test (rapid test or ELISA) that shows the person is HIV +
Possibility of continuous participation in training sessions
Women whose sexual self-efficacy score is between 0 and 10
Exclusion criteria:
Taking drugs that affect sexual function such as antidepressants, blood pressure and ....
Infection of the patient's spouse with sexual dysfunction
Consumption of alcohol and psychotropic substances by the patient and his spouse
Having other physical and acute diseases and endocrine disorders such as diabetes and thyroid disorders based on the patient's medical record
Simultaneous use of counseling and other educational services to increase sexual self-efficacy
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The method of appointment will be random and with the method of random permutation blocks with block size 4 (using the table related to random permutations) and the ratio assigned to the intervention and control group will be 1: 1. The randomization list is prepared by a statistician. The code assigned to the intervention or control group will be placed in closed envelopes. These envelopes will be given to the secretary of the center. In this way, data analysts will not know what group everyone is in until they start studying.
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 Jundishapur University of Medical Sciences
Street address
Golestan Ave, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.AJUMS.REC.1399.967
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
sexual self-efficacy
Timepoint
At the beginning of the study, week 8 and week 12 after the intervention
Method of measurement
Sexual Self-Efficacy Questionnaire by Bells et al
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using purposive sampling, samples are selected from among women who are eligible and have inclusion criteria and no exclusion criteria. First, the same explanations are given to each eligible individual about the objectives of the research and how to intervene. And written consent is obtained from eligible individuals. Completion of demographic and sexual self-efficacy questionnaire is done by samples that meet the inclusion criteria. The total number of participants in the study is based on statistical calculations of 60 people in each group 30 People will enter the research and then are divided into two groups of intervention and control by random block allocation method (4 blocks and 1: 1 allocation ratio). The sample size of people in group therapy with mindfulness approach should not exceed 14 people, because the effectiveness of psychotherapy decreases with increasing the number of groups, so the intervention group will be divided into three groups of 7 people, then the intervention as a pre-test, then The test and follow-up stage are performed so that all women in the three groups complete the sexual self-efficacy questionnaire at the beginning of the study, week 8 and week 12 after the intervention as a self-report. Counseling is done by a trained researcher and supervised by a consultant professor at the center. The women in the intervention group undergo 8 sessions of group counseling (one session per week) with a mindfulness-based cognitive therapy approach aimed at improving sexual self-efficacy. Meetings are held in groups, one 2-hour session per week as planned between the counselor and the client. During the sessions about realizing the wandering mind, full awareness of thoughts and feelings, emphasizing that negative feelings are not permanent, that thoughts They are not the truth, and the ways in which thoughts can be viewed from different angles are discussed, and people's new beliefs are discussed. Reminders to do homework and participate in group therapy are reminded daily by the researcher via SMS. After the end of 8 treatment sessions and 12 weeks after the intervention, the sexual self-efficacy questionnaire is completed by the intervention and control group.
Category
Treatment - Other
2
Description
Control group: Due to the low level of sexual self-efficacy, the control group did not receive any intervention. In order to make the research ethical, after completing the study, an educational booklet and a summary of the contents of the sessions are given to them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz High Risk Diseases Center
Full name of responsible person
Shahla Molavi
Street address
Zaytoun Karmandi - Zavieh St. - Next to Abuzar Hospital - Opposite Hedayat Alley - Upper floor of Children's Clinic
City
Ahvaz
Province
Khouzestan
Postal code
5587774144
Phone
+98 61 3445 4600
Email
fgnrfrd@ygug.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Street address
Golestan St., Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 4329
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan St., Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 4329
Email
parvinabedi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan St., Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 4329
Email
parvinabedi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvin Abedi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan St., Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 4329
Email
parvinabedi@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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used for future studies.
From where data/document is obtainable
Send email to the responsible author Dr. Parvin Abedi parvinabedi@gmail.com
What processes are involved for a request to access data/document
After sending the email and reviewing the request and verifying the study, the request will be answered.