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IRCT20200518047500N1 IRCT 2020-06-21 Tehran University of Medical Sciences Investigating the Impact of Intervention on Pregnant Women's Concerning About Screening Tests Investigating of the effect of educational-psychological intervention on anxiety and worry of pregnant women in the process of fetal screening tests: randomized clinical trial with control group. 2020-06-21 anticipated 159 Complete https://irct.ir/trial/48254 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Permuted-Blok Randomization. In this way, all possible modes for placing the letters A, B and C in the blocks will be considered. The size of the blocks is randomly selected by the computer (for example, blocks of size 6, 9, 12, and 18 are available in each block with equal numbers of each letter (group)). This will eliminate the possibility of revealing the last allocation in each block by randomly selecting the blocks, Blinding description: People in the control group are told that they have been surveyed to achieve the study goals. Both intervention groups receive group training virtually, but are not aware of other group training. N/A Condition 1: Anxiety. Condition 2: Worry. Intervention 1: For (Group A), the intervention will be designed as group training counseling through cyberspace. This virtual- group counseling is held at two-day intervals in three 45-minute sessions with 6 to 8 pregnant women. The content of the intervention is:  Introducing the researcher to the participants. People briefly introduce themselves in the group The purpose of the training session is to introduce (familiarity with fetal screening tests and methods).  Introduction of different types of screening tests including: 1- Combination screening test of the first trimester 2-Screening test of the second trimester 3- Non-invasive perinatal test Explain the nature of laboratory screening. Schedule scheduling tests Interpretation of screening test results (concept of chance or probability). How to track according to the results of the experiments.  Explanation of diagnostic methods (chorionic villus sampling sampling and amniocentesis) including: technique, timing, possible risks.  Description of termination or continuation of pregnancy, including: signs and symptoms and characteristics of children with Down syndrome; Conditions for the care of a child with disabilities due to cultural, social and government assistance; Legal and religious conditions for termination of pregnancy in Iran. This content will be presented in the first session as a lecture by the researcher to the participants in the session. In the next session, the researcher will answer the participants' questions and provide the group with a written file of the same content. In the third session, while removing the ambiguities of the participants and answering their possible questions, a PowerPoint file with pictures and educational tables will be provided to the participants. Intervention 2: Intervention group B: group educational-psychological counseling. The intervention is designed as a group-educational-psychological group consultation in three 45-minute sessions with the presence of 6 to 8 pregnant women and with two-day intervals. In the first session, the same educational content prepared for group A will be presented as a speech, and at the end of the session, a written file with the content of the first session speech will be provided to the group. In the second session, the first and second parts of the psychological intervention will be performed. In the third session, the third part of the psychological intervention will be performed, the assignments of the previous session will be reviewed and the questions and ambiguities of the participant will be answered, and the PowerPoint file with educational and psychological content along with pictures and tables will be provided. Intervention 3: Control group: They do not receive any intervention. Yes - There is a plan to make this available What will be shared: A part of the data, such as information about the main consequence or the like, can be shared. When: It is possible to access the results 6 months after publication To whom: It will only be available to researchers working in academic and scientific institutions Conditions: Only in order to be aware of the research process by academic researchers Where to obtain: Email address: Mitra Arjomandi Far arj7087@yahoo.com How to obtain: Up to one month after receiving the request by email Comments:
public Mitra Arjmandifar
Tehran University of Medical Science, School of Nursing and Midwifery, Nosrat street, Tohid square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 5592 0380 arj7087@yahoo.com Tehran University of Medical Sciences scientific Mitra Arjmandifar
Tehran University of Medical Science, School of Nursing and Midwifery, Nosrat street, Tohid square
Tehran Iran (Islamic Republic of) 141973317 +98 21 5592 0380 arj7087@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Being a Muslim and an Iranian pregnant women with <11-week pregnancy age who have referred to health care medical centers for the first time to make medical record for their current pregnancy Finishing at least fifth elementary school level and access and the possibility of using cyberspace Being possible to access him for at least the next 10 weeks. no limit no limit Female previous history of screening or diagnostic tests for fetal chromosomal abnormalities employment of research units in health centers have a fetus with Down syndrome or abnormalities history of known mental disorders, or taking psychiatric drugs Prevention Prevention N/A For (Group A), the intervention will be designed as group training counseling through cyberspace. This virtual- group counseling is held at two-day intervals in three 45-minute sessions with 6 to 8 pregnant women. The content of the intervention is:  Introducing the researcher to the participants. People briefly introduce themselves in the group The purpose of the training session is to introduce (familiarity with fetal screening tests and methods).  Introduction of different types of screening tests including: 1- Combination screening test of the first trimester 2-Screening test of the second trimester 3- Non-invasive perinatal test Explain the nature of laboratory screening. Schedule scheduling tests Interpretation of screening test results (concept of chance or probability). How to track according to the results of the experiments.  Explanation of diagnostic methods (chorionic villus sampling sampling and amniocentesis) including: technique, timing, possible risks.  Description of termination or continuation of pregnancy, including: signs and symptoms and characteristics of children with Down syndrome; Conditions for the care of a child with disabilities due to cultural, social and government assistance; Legal and religious conditions for termination of pregnancy in Iran. This content will be presented in the first session as a lecture by the researcher to the participants in the session. In the next session, the researcher will answer the participants' questions and provide the group with a written file of the same content. In the third session, while removing the ambiguities of the participants and answering their possible questions, a PowerPoint file with pictures and educational tables will be provided to the participants. Intervention group B: group educational-psychological counseling. The intervention is designed as a group-educational-psychological group consultation in three 45-minute sessions with the presence of 6 to 8 pregnant women and with two-day intervals. In the first session, the same educational content prepared for group A will be presented as a speech, and at the end of the session, a written file with the content of the first session speech will be provided to the group. In the second session, the first and second parts of the psychological intervention will be performed. In the third session, the third part of the psychological intervention will be performed, the assignments of the previous session will be reviewed and the questions and ambiguities of the participant will be answered, and the PowerPoint file with educational and psychological content along with pictures and tables will be provided. Control group: They do not receive any intervention Anxiety score in the Spilberger Anxiety Short Form Questionnaire. Timepoint: Before the start of the study and in the 14th and 20th weeks of pregnancy. Method of measurement: the Spilberger Anxiety Short Form Questionnaire. Concern Score in Cambridge Worry Scale. Timepoint: Before the start of the study and in the 14th and 20th weeks of pregnancy. Method of measurement: Cambridge Worry Scale. Tehran University of Medical Sciences Approved 2018-09-01 School of Nursing and midwifery & Rehabitation; Tehran University of Medical Scienses Nosrat street; Tohid square Tehran Tehran Iran (Islamic Republic of)