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IRCT20210317050736N1 IRCT 2021-04-27 Ahvaz University of Medical Sciences The effect of mindfulness counseling on sexual self-efficacy of HIV positive women The effect of mindfulness counseling on sexual self-efficacy of HIV positive women 2021-05-05 anticipated 66 Complete https://irct.ir/trial/55259 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Human Immunodeficiency virus. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The data can be used for future studies. Where to obtain: Send email to the responsible author Dr. Parvin Abedi parvinabedi@gmail.com How to obtain: After sending the email and reviewing the request and verifying the study, the request will be answered. Comments:
public Parvin Abedi
Golestan St., Ahvaz University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3311 4329 parvinabedi@gmail.com Ahvaz University of Medical Sciences scientific Parvin Abedi
Golestan St., Ahvaz University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3311 4329 parvinabedi@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 25 years 45 years Female 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 B20 Human immunodeficiency virus [HIV] disease Treatment - Other Other 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. 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. 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. Ahvaz University of Medical Sciences Approved 2021-03-17 Ethics Committee of Jundishapur University of Medical Sciences Golestan Ave, Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)