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IRCT20220116053733N1 IRCT 2022-01-27 Kashan University of Medical Sciences The effectiveness of Mindfulness integrated cognitive behavior therapy on psychological symptoms, quality of life and Marital Satisfaction The effectiveness of Mindfulness integrated cognitive behavior therapy on psychological symptoms, quality of life and Marital Satisfaction in infertile women undergoing IVF treatment 2022-02-20 anticipated 44 Complete https://irct.ir/trial/61344 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 44 (two groups of 22) and permuted block randomization method (block size=4) (11 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (44th person), Blinding description: Consequences are with self-report tools so there is no need to blind the evaluator. The data is entered into SPSS software by the evaluator and by changing the names of the groups, the analyst will not be informed about the assigned treatment. After collecting the data, the names of the groups will be changed by the researcher. N/A Female infertility. Intervention 1: Intervention group: Structured 8-session treatment that is held according to the protocol for 90 minutes a week and teaches clients to internalize their attention in order to regulate their emotions and attention, and then externalize their regulated emotions and attention to manage their problems and use. Intervention 2: Control group: In order to comply with ethical considerations, 4 sessions of developmental psychology training will be provided. Yes - There is a plan to make this available What will be shared: Only part of the data such as information about the main outcome or the like and demographic information can be shared. When: The access period will be available 2 years after the results are published and up to one year later. To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: In case of any use, the names of the researchers of the project should be mentioned in the Thanksgiving section. No one has the right to use the data for non-human consumption, such as cases that endanger and endanger human life. Submitting an application must be in accordance with the academic procedure and will be reviewed for up to one month. Ask the person not to have any connection with anti-humanitarian and terrorist institutions. Where to obtain: Seyed Hossein Masoumi Lari Kashan University of Medical Sciences School of Medicine hmasoumi.psy@yahoo.com How to obtain: According to the circumstances, it will be reviewed and answered by the person in charge. Comments:
public Abdollah OMIDI
Kashan University of Medical Sciences, Qutb Ravandi
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 0021 Abomidi20@yahoo.com Kashan University of Medical Sciences scientific Seyed Hossein Masoumi Lari
Kashan University of Medical Sciences, Qutb Ravandi
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 0021 hmasoumi.psy@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Have a history of infertility for at least one year one year applying for IVF infertility treatment no history of experience in Cognitive-behavioral therapies and mindfulness at least age 25 years old Have the ability to read and write marital satisfaction score 40 and below in the Enrich Questionnaire psychological symptoms score 44 and above in the short form Questionnaire psychological symptoms 25 years no limit Female Physical inability to perform exercises Use of drugs and other addictive substances N97 Female infertility Behavior Other Intervention group: Structured 8-session treatment that is held according to the protocol for 90 minutes a week and teaches clients to internalize their attention in order to regulate their emotions and attention, and then externalize their regulated emotions and attention to manage their problems and use. Control group: In order to comply with ethical considerations, 4 sessions of developmental psychology training will be provided. Score of psychological symptoms in the short form questionnaire of psychological symptoms. Timepoint: Measurement of psychological symptoms before the intervention eight weeks after the start of the intervention and two months after the end of the intervention. Method of measurement: Short form of psychological symptoms questionnaire. Global Health Quality of Life Questionnaire score. Timepoint: Measurement of quality of life before the intervention eight weeks after the start of the intervention and two months after the end of the intervention. Method of measurement: Global Health Quality of Life Questionnaire. Marital Satisfaction Score in Enrich Marital Satisfaction Questionnaire. Timepoint: Measurement of marital satisfaction before the intervention eight weeks after the intervention and two months after the intervention. Method of measurement: Enrich Marital Satisfaction Questionnaire. Kashan University of Medical Sciences Approved 2022-01-03 Ethics Committee of Kashan University of Medical Sciences Qutb Ravandi Kashan Isfehan Iran (Islamic Republic of)