Determining the effect of mindfulness counseling on sexual self-esteem of HIV positive women
Design
The clinical trial has two groups of control and intervention block block allocation method, on 50 patients.
Settings and conduct
The sample of HIV-positive women referred to the High-Risk Diseases Center of Isfahan, who were selected from the research community and have low sexual self-esteem, the total number of participants is 50, with 25 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-esteem questionnaire as a self-report.
Participants/Inclusion and exclusion criteria
Inclusion criteria: HIV positive women, willingness to participate in research, married, age between 18-45 years, monogamy of women and people whose score in the Sexual Self-Esteem Questionnaire is a standard deviation below average. Inclusion criteria: simultaneous use of counseling and other educational services to increase self-esteem, severe psychiatric disorders, stressful and unfortunate events during the past 3 months, alcohol and psychotropic substances by the patient and spouse It is associated with other acute physical illnesses and endocrine disorders such as diabetes and thyroid disorders based on the patient's medical record.
Intervention groups
The intervention and control group includes HIV-positive women with low sexual self-esteem. During 8 sessions of group counseling (one session per week), with a mindfulness-based cognitive therapy approach to improve sexual self-esteem. The control group did not receive any intervention.
Main outcome variables
Sexual self-esteem؛ Sexual experience and skills؛Sexual attractiveness؛Sexual control؛ Sexual moral judgment؛ Sexual adaptation
General information
Reason for update
Acronym
HIV
IRCT registration information
IRCT registration number:IRCT20210614051580N1
Registration date:2021-10-10, 1400/07/18
Registration timing:prospective
Last update:2021-10-10, 1400/07/18
Update count:0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
Shamim Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 1644
Email address
kiani.shamim@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-30, 1400/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness counseling on sexual self-esteem of HIV positive women
Public title
The effect of mindfulness counseling on sexual self-esteem of HIV positive women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research
Married
Age between 18-45 years
People whose score in the Sexual Self-Esteem Questionnaire is a standard deviation less than the average
Women monogamy
HIV positive women
Exclusion criteria:
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 in order to increase self-esteem
Having severe psychiatric disorders
Occurrence of stressful and unfortunate events during the last 3 months
Consumption of alcohol and psychotropic substances by the patient and his wife
Age
From 18 years old to 45 years old
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
How to make a block accident (9 blocks of 6). Create two groups A and B naming. After adding 6 of the two groups A and B, we write, for example, ABABAB -AAABBB-ABBAAB-BBBAAA
Assign one combination to each block and assign people in each block to treatment groups.
The randomization list is based on a table of random numbers.
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 Ahwaz University of Medical Sciences
Street address
No. 156c,Janbazan St., Ostad Mehryar Alley
City
Esfahan
Province
Isfehan
Postal code
15794-61357
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.AJUMS.REC.1400.160
Health conditions studied
1
Description of health condition studied
human immunodeficiency viruses
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Sexual self-esteem
Timepoint
At the beginning of the study, week 8 and week 12 after the intervention
Method of measurement
HIV Positive Women Sexual Self-Esteem Questionnaire(SSEI-W-SF)
2
Description
sexual experience and skills
Timepoint
At the beginning of the study, week 8 and week 12 after the intervention
Method of measurement
HIV Positive Women Sexual Self-Esteem Questionnaire(SSEI-W-SF)
3
Description
sexual attractiveness
Timepoint
At the beginning of the study, week 8 and week 12 after the intervention
Method of measurement
HIV Positive Women Sexual Self-Esteem Questionnaire(SSEI-W-SF)
4
Description
sexual control
Timepoint
At the beginning of the study, week 8 and week 12 after the intervention
Method of measurement
HIV Positive Women Sexual Self-Esteem Questionnaire(SSEI-W-SF)
5
Description
sexual moral judgment
Timepoint
At the beginning of the study, week 8 and week 12 after the intervention
Method of measurement
HIV Positive Women Sexual Self-Esteem Questionnaire(SSEI-W-SF)
6
Description
sexual adaptation
Timepoint
At the beginning of the study, week 8 and week 12 after the intervention
Method of measurement
HIV Positive Women Sexual Self-Esteem Questionnaire(SSEI-W-SF)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 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-esteem. Group sessions, one 90-minute session per week as scheduled between the counselor and clients. Full awareness of thoughts and feelings Emphasizing the non-permanence of negative feelings, that thoughts are not true, and the ways in which thoughts can be viewed from different angles, and people's new beliefs are discussed. The content of the sessions is as follows: Session 1: (Automatic guidance) Raisin-conscious mind-eating exercise: A meditation in which participants spend a few minutes examining the sensory-visual, olfactory, and taste characteristics and touch of a raisin seed. And Exercise Exam: A meditation in which participants draw their attention to senses in different parts of the body. Session 2: (Facing Obstacles) Practice Examining the Body and Practicing Thoughts and Feelings: Participants visualize a scenario such as a friend not saying hello, then examine their reactions to such an event and the effect of mood. Session 3: (Presence of mind from breathing) Three-minute breathing space and conscious mind walking. Participants are invited to move according to the breathing pattern, the position of the legs and the bodily sensations caused by attention. Session 4: (Staying in the present) Meditation practice of seeing and hearing: Participants are asked to focus their attention on visual sights or sounds and to slowly return to these senses when their mind wanders. Session 5: (Reception) 40 minutes of sitting meditation, review exercise: Participants pay attention to breathing, body senses, sounds and thoughts. Also pay attention to the confusion of the mind. Session 6: (Thoughts are not facts) Imagine sitting for 40 minutes imagining as images on a movie screen or passing clouds or river leaves. Session 7: (Self-care) Pointing to the relationship between mood and activity: Preparing a list of activities and dividing them into increasing and decreasing the level of mood and energy Session8: (Using what has been learned) Review of past content, reflection
Category
Treatment - Other
2
Description
Control group: Due to the fact that the control group did not receive any intervention despite the low level of sexual self-efficacy. 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
Navab Safavid High Risk Disease Center of Isfahan
Full name of responsible person
Shamim kiyani
Street address
Ahmadabad Square, Bozorgmehr St., Navab Safavi Comprehensive Health Service Center
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3227 5250
Fax
+98 81 7467 3461
Email
fgnrfrd@edu.med.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon
Street address
Golestan St., Ahvaz University of Medical Sciences
City
ahwaz
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
Mitra Tadayon
Position
the coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan St., Ahvaz University of Medical Sciences
City
ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 4329
Email
mitratadayon2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon
Position
the coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan St., Ahvaz University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 4329
Email
mitratadayon2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon
Position
the coach
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan St., Ahvaz University of Medical Sciences
City
ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 4329
Email
mitratadayon2000@yahoo.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
No - There is not 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 Ms. Mitra Tadayon
mitratadayon2000@yahoo.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.