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IRCT20160619028528N7 IRCT 2023-02-01 Mazandaran University of Medical Sciences The effect of online brief mindfulness-based counseling on infertility related distress in infertile women under treatment The effect of online brief mindfulness-based counseling on infertility related distress in infertile women under treatment: A randomized controlled clinical trial 2023-02-14 anticipated 70 Complete https://irct.ir/trial/66340 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The blocked random allocation methods will randomly assign the samples to two intervention groups (awareness attention) and a control group (routine care). This method is usually used in order to balance the number of samples allocated to each of the studied groups. This feature helps the researcher to have the same number of samples allocated to the intervention and control groups of the study in cases where intermediate analysis is needed during the implementation of the sampling process. For this purpose, blocks of four will be considered. The six blocks may be TTCC, CTTC, CTCT, CCTT, TCTC, and TCCT, where T is for the intervention group and C is for the control group. The rand between functions in Excel will be used to select the blocks randomly. The production numbers will be between 1 and 6 and based on the production number of the desired block, all 4 samples will be assigned to the intervention and control groups, Blinding description: Due to the nature of the intervention, it will not be possible to blind the participants and the researcher responsible for the intervention during the intervention process, therefore, in order to control the bias of blinding at the level of the evaluator (evaluator bias), the process of blinding will be carried out in the people who are responsible for collecting information and analyzing data. N/A Distress of infertile women. Intervention 1: The abbreviated awareness course for four group training sessions, each group of seven people will hold 2 hours each session and once a week for 4 weeks. This course will include all the techniques taught in the 8-week course including: mindful breathing, body scanning, guided imagery, kindness, mindful eating, mindful walking or other movements, mindful conversations, and observing one's emotions. Mindful walking or other movements will be used in place of the yoga used during the 8-week course to vary the movements for each person depending on their physical ability (such as sitting in a chair). In order to adapt the content of the required sessions that is shortened in this intervention, the researcher will change the regular education by introducing more than one topic in each class, and also a shorter period of time will be allocated for each topic (about 45 minutes) and less time for Practice of each technique will be provided in class. After each session, participants will be given assignments to practice mindfulness techniques for 20 to 30 minutes outside of class. It is believed that home practice less than 2 days per week is not sufficient and that participants who are more engaged in the session spend more time practicing home skills and are therefore likely to experience better outcomes.Supportive items of the main intervention include a mindfulness manual. Various topics include mindfulness meditation instructions, definition of mindfulness, the importance of being present in the present moment, progress notes and forms for exercises. The first half hour is dedicated to formal mindfulness exercises. Then the participants talk about their feelings, what they noticed and how they found this experience. Each session ends with 3 minutes of breathing exercises. Intervention 2: Control group:The control group receives routine care. 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 Negin Salarian
Royan.Shohada Street.Kalej 5
Noor Iran (Islamic Republic of) 4656184933 +98 11 4451 7185 N.Salarian@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr. Zeinab Hamzehgardeshi
Nasibeh Nursing and Midwifery Faculty, Amir Mazandarani Street
Sari Iran (Islamic Republic of) 48431-63181 009833367342 z.hamzehgardeshi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iranian nationality Proficiency in Persian language Having smartphones and being able to use them Women less than 45 years old Diagnosed infertility Women treated with assisted reproductive methods (IVF.IUI) (Anti Mullerian Hormone (AMH)more than 5/ng/mL no limit 45 years Female - Intention to use donated embryos, eggs or surrogates Cancellation of the treatment plan for any reason by the doctor People who are under the advice of a psychologist or psychiatrist at the time of the study or at least one month before the start of the study People with major psychiatric disorders at the time of study Suffering from systemic diseases such as diabetes, high blood pressure, hyperlipidemia, and thyroid gland disease; Based on treatment history, file information, and research unit report. Based on the treatment history, file information, and research unit report. Death of a relative or an unfortunate accident at least 3 months before the start of the intervention Occurrence of pregnancy detected by blood test during the study Psychiatric drug use (self-report) Stepchild Use of cigarettes, hookahs and alcoholic beverages People with a history of previous marriages - people who were eligible to receive or needed to be prescribed any psychotropic medication or psychotherapy counseling during the study. Behavior Behavior The abbreviated awareness course for four group training sessions, each group of seven people will hold 2 hours each session and once a week for 4 weeks. This course will include all the techniques taught in the 8-week course including: mindful breathing, body scanning, guided imagery, kindness, mindful eating, mindful walking or other movements, mindful conversations, and observing one's emotions. Mindful walking or other movements will be used in place of the yoga used during the 8-week course to vary the movements for each person depending on their physical ability (such as sitting in a chair). In order to adapt the content of the required sessions that is shortened in this intervention, the researcher will change the regular education by introducing more than one topic in each class, and also a shorter period of time will be allocated for each topic (about 45 minutes) and less time for Practice of each technique will be provided in class. After each session, participants will be given assignments to practice mindfulness techniques for 20 to 30 minutes outside of class. It is believed that home practice less than 2 days per week is not sufficient and that participants who are more engaged in the session spend more time practicing home skills and are therefore likely to experience better outcomes.Supportive items of the main intervention include a mindfulness manual. Various topics include mindfulness meditation instructions, definition of mindfulness, the importance of being present in the present moment, progress notes and forms for exercises. The first half hour is dedicated to formal mindfulness exercises. Then the participants talk about their feelings, what they noticed and how they found this experience. Each session ends with 3 minutes of breathing exercises. Control group:The control group receives routine care Secondary outcome:Improving quality of life. Timepoint: Before intervention ،immediately after the intervention ،one month after the completion of the intervention in the intervention groups (recipient of online counseling and control). Method of measurement: Infertile women's quality of life questionnaire. Perceived stress. Timepoint: Before intervention ،immediately after the intervention ،one month after the completion of the intervention in the intervention groups (recipient of online counseling and control). Method of measurement: Newton's infertility stress questionnaire. Laboratory pregnancy testing. Timepoint: Before intervention ،immediately after the intervention ،one month after the completion of the intervention in the intervention groups (recipient of online counseling and control). Method of measurement: blood test. Perceived stress of infertile women. Timepoint: Before, immediately after the intervention, and one month after the completion of the intervention in the intervention groups (recipient of online counseling and control. Method of measurement: Newton's infertility stress questionnaire,. Quality of life score of infertile women. Timepoint: Before, immediately after the intervention, and one month after the completion of the intervention in the intervention groups (recipient of online counseling and control. Method of measurement: Infertile women's quality of life questionnaire. Laboratory pregnancy testing. Timepoint: Before intervention ،immediately after the intervention ،one month after the completion of the intervention in the intervention groups (recipient of online counseling and control). Method of measurement: blood test. Mazandaran University of Medical Sciences Approved 2022-10-11 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for research, Mazandaran University of Medical Sciences ,Moalem Square, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)