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IRCT20180218038783N8 IRCT 2024-01-20 Babol University of Medical Sciences Effectiveness of telephone counseling based on mindfulness on relational concern of infertile women Effectiveness of telephone counseling based on mindfulness on relational concern of infertile women 2024-01-21 anticipated 80 Recruiting https://irct.ir/trial/74296 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants (ratio 1:1) will be placed in two training and control groups (group A and B) using the randomization method with random blocks of 4 (produced by online randomizer). In such a way that the researcher cannot predict in which group the next person will be placed. The random allocation list will be solely at the discretion of the study administrator. The randomization list is taken from the following site: Sealed Envelope Ltd. 2022. Create a blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 31 Dec 2023], Blinding description: In this study, due to the nature of the intervention, it will not be possible to blind the researcher in the first stage. Blinding will only be done for the data analyst. N/A Condition 1: infertility. Condition 2: sexual relational concern. Intervention 1: Intervention group: Counseling based on mindfulness will be conducted in eight sessions for 8 weeks (one session per week) by the researcher with the help of a psychiatrist based on the standard Kabat-Zinn protocol, 7 sessions of which will be held by contacting the participants for 30 minutes. . The first meeting will be held in person at Fatemeh Al-Zahra Infertility Center in order to explain the objectives, stages of the study, a summary of the method of implementation of the work verbally, obtaining informed consent and also assuring the participants to keep their information confidential. In the first session and before the consultation, demographic and midwifery questionnaires and sexual relational concern questionnaires will be completed by the samples. Each session will have a goal and during that mindfulness exercises will be done. Also, mindfulness tasks are suggested for women to practice in everyday events. In the intervals between the sessions, the researcher will respond to the calls of the samples to clear their doubts and questions. After a period of 8 weeks, the women's sexual relational concern questionnaire will be completed virtually by the participants. To check the stability of the educational intervention of the present study, after a one-month follow-up period (twelfth week), the samples are again asked to complete the sexual relational concern questionnaire in virtual form. Intervention 2: Control group: At Fatemeh Al-Zahra Infertility Center, in order to express the goals, stages of the study, a summary of the method of performing the work verbally, obtaining informed consent, and also assuring the participants to keep their information confidential, we will talk to them and request them. to complete demographic, midwifery and sexual relational concern questionnaires. No intervention will be done for the control group. Again, 8 weeks later and 12 weeks later, the control group will complete the sexual relational concern questionnaire virtually.Routine care includes standard infertility treatments. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Fereshteh Behmanesh
Keshavarz St
Babol Iran (Islamic Republic of) 4717647745 +98 911 213 5312 f.behmanesh2015@gmail.com Babol University of Medical Sciences scientific Fereshteh Behmanesh
Keshavarz St
Babol Iran (Islamic Republic of) 4774547176 +98 911 213 5312 f.behmanesh2015@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Diagnosis of infertility Ability to read and write Having a personal cell phone Age less than 50 years Attending at least 6 mindfulness intervention sessions no limit 50 years Female Attending other psychological interventions or training Having a known psychiatric illness N97 F41 Female infertility Other anxiety disorders Treatment - Other N/A Intervention group: Counseling based on mindfulness will be conducted in eight sessions for 8 weeks (one session per week) by the researcher with the help of a psychiatrist based on the standard Kabat-Zinn protocol, 7 sessions of which will be held by contacting the participants for 30 minutes. . The first meeting will be held in person at Fatemeh Al-Zahra Infertility Center in order to explain the objectives, stages of the study, a summary of the method of implementation of the work verbally, obtaining informed consent and also assuring the participants to keep their information confidential. In the first session and before the consultation, demographic and midwifery questionnaires and sexual relational concern questionnaires will be completed by the samples. Each session will have a goal and during that mindfulness exercises will be done. Also, mindfulness tasks are suggested for women to practice in everyday events. In the intervals between the sessions, the researcher will respond to the calls of the samples to clear their doubts and questions. After a period of 8 weeks, the women's sexual relational concern questionnaire will be completed virtually by the participants. To check the stability of the educational intervention of the present study, after a one-month follow-up period (twelfth week), the samples are again asked to complete the sexual relational concern questionnaire in virtual form. Control group: At Fatemeh Al-Zahra Infertility Center, in order to express the goals, stages of the study, a summary of the method of performing the work verbally, obtaining informed consent, and also assuring the participants to keep their information confidential, we will talk to them and request them. to complete demographic, midwifery and sexual relational concern questionnaires. No intervention will be done for the control group. Again, 8 weeks later and 12 weeks later, the control group will complete the sexual relational concern questionnaire virtually.Routine care includes standard infertility treatments. The score of relational concern dimension of sexual satisfaction questionnaire of Chesley et al. Timepoint: Before, after and one month after the end of study. Method of measurement: The 6-question relational concern questionnaire, which is one of the dimensions of the multidimensional sexual satisfaction questionnaire of Chesley et al. Babol University of Medical Sciences Approved 2023-11-27 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences. Keshavarz St. Babol Mazandaran Iran (Islamic Republic of)