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IRCT20230726058936N1 IRCT 2023-08-29 Ahvaz University of Medical Sciences The Effect of Cognitive Behavioral Counseling on Anxiety Thoughts in Pregnant Women with a History of Fetal Abnormality The effect of counseling based on cognitive behavioral therapy on anxiety thoughts of pregnant women with a history of fetal abnormalities 2023-08-22 anticipated 46 Complete https://irct.ir/trial/71727 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: The questionnaire completed at the beginning of the study will be as a pretest of both intervention and control groups, and then the intervention group will receive cognitive-behavioral therapy in the form of 8 sessions of 90 minutes, once a week, and the control group will only receive routine prenatal care, Randomization description: . The method of assigning intervention to the subjects is randomized, using random permutation blocks with block size 4 (using the table related to random permutations) and with a ratio of 1:1. The randomization list is prepared by a statistical expert. Codes assigned to qualified individuals by an outside person who does not know the research objectives will be plThey will not know who is in the group, Blinding description: This way, the researcher and participants will be unaware of who is in what group until the study begins. N/A anxiety thoughts of pregnant women with a history of fetal abnormalities. Intervention 1: Intervention group: The intervention in this study starts from the age of 18 to 20 weeks of pregnancy (that is, after the results of fetal abnormality screening and ultrasound) and the end of the intervention is after 8 weeks of counseling session. The intervention group will receive cognitive-behavioral therapy in the form of 8 sessions of 90 minutes, once a week. Session plan: The first session: introducing the members to each other, the rules and structure of the group, explaining the purpose of the study to the participants, emphasizing Confidentiality of answers, treatment contract, description of how to complete the questionnaire, familiarization with the problem of anxiety thoughts caused by fetal abnormality, description of cognitive-behavioral therapy and the beginning of the second session training: cognitive skills training, review of the topics of the first session, relaxation training, skill training Imagination, presentation of the task of the third session: getting to know the negative thoughts and beliefs that cause negative feelings towards the current pregnancy with regard to the experience of abnormality in the previous pregnancy, reviewing the previous session and checking the completion of the task, describing different types of maladaptive cognitions, recognizing Inconsistent thoughts and self-talks, description of emotions associated with inconsistent cognition, presentation of the assignment of the fourth session: explanation of the effect of psychological factors on the outcome of the current pregnancy, review of the previous session and review of the assignment, training of psychological factors (founding factors, revealing factors, maintaining factors) ), presentation of the task of the fifth session: cognitive restructuring, review of the previous session and review of homework, cognitive restructuring and change of negative attitude towards the current pregnancy, presentation of the task of the sixth session: teaching to correct anxious thoughts, review of the previous session and review of homework, review Anxious thoughts and challenging their validity, presentation of the assignment of the seventh session: training to replace positive thoughts instead of anxious thoughts, review of the previous session and review of the assignment of the eighth session: training of communication skills and problem solving, overview, implementation of the post-test. Intervention 2: Control group: El cuestionario de información demográfica y el cuestionario de pensamientos de ansiedad serán aplicados a gestantes con antecedentes de anomalías fetales con edad gestacional de 18-20 semanas que remitan a centros de salud que reúnan las condiciones para ingresar al estudio, y el grupo control recibirá únicamente los cuidados habituales del embarazo.Tras finalizar el estudio, el grupo control recibirá el tratamiento basado en el asesoramiento cognitivo-conductual en forma de reunión presencial junto con un CD con el material enseñado al grupo intervención. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Zeinab Davoodi
Davood Davoodi Alley, Takhti Sq., Emam Ave.
Izeh Iran (Islamic Republic of) 6391753611 +98 61 4365 1444 Jan_jani36@yahoo.com Ahvaz University of Medical Sciences scientific Zeinab Davoudi
Imam Street, Daud Davodi Street
Izeh Iran (Islamic Republic of) 6391753611 +98 61 4365 1444 jan_jani36@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 1. Minimum primary education 2. Age 18 to 40 years 3. Gestational age 18 to 20 weeks 4. History of fetal abnormality in previous pregnancy 5. Score one standard deviation above the mean in Wells anxiety thoughts questionnaire 18 years 40 years Female 1. Chronic diseases such as heart disease, high blood pressure, diabetes 2. Mental illness in recent years and taking psychotropic drugs 3. Drug and Cigarette Addiction 4. Pregnancy complications such as preeclampsia, bleeding 5. Absence of more than two sessions in therapy sessions 6. Attending counseling sessions during the study or three months before the study 7. Dealing with stressful events such as separation crisis or death of first-degree relatives Other Other Intervention group: The intervention in this study starts from the age of 18 to 20 weeks of pregnancy (that is, after the results of fetal abnormality screening and ultrasound) and the end of the intervention is after 8 weeks of counseling session. The intervention group will receive cognitive-behavioral therapy in the form of 8 sessions of 90 minutes, once a week. Session plan: The first session: introducing the members to each other, the rules and structure of the group, explaining the purpose of the study to the participants, emphasizing Confidentiality of answers, treatment contract, description of how to complete the questionnaire, familiarization with the problem of anxiety thoughts caused by fetal abnormality, description of cognitive-behavioral therapy and the beginning of the second session training: cognitive skills training, review of the topics of the first session, relaxation training, skill training Imagination, presentation of the task of the third session: getting to know the negative thoughts and beliefs that cause negative feelings towards the current pregnancy with regard to the experience of abnormality in the previous pregnancy, reviewing the previous session and checking the completion of the task, describing different types of maladaptive cognitions, recognizing Inconsistent thoughts and self-talks, description of emotions associated with inconsistent cognition, presentation of the assignment of the fourth session: explanation of the effect of psychological factors on the outcome of the current pregnancy, review of the previous session and review of the assignment, training of psychological factors (founding factors, revealing factors, maintaining factors) ), presentation of the task of the fifth session: cognitive restructuring, review of the previous session and review of homework, cognitive restructuring and change of negative attitude towards the current pregnancy, presentation of the task of the sixth session: teaching to correct anxious thoughts, review of the previous session and review of homework, review Anxious thoughts and challenging their validity, presentation of the assignment of the seventh session: training to replace positive thoughts instead of anxious thoughts, review of the previous session and review of the assignment of the eighth session: training of communication skills and problem solving, overview, implementation of the post-test Control group: El cuestionario de información demográfica y el cuestionario de pensamientos de ansiedad serán aplicados a gestantes con antecedentes de anomalías fetales con edad gestacional de 18-20 semanas que remitan a centros de salud que reúnan las condiciones para ingresar al estudio, y el grupo control recibirá únicamente los cuidados habituales del embarazo.Tras finalizar el estudio, el grupo control recibirá el tratamiento basado en el asesoramiento cognitivo-conductual en forma de reunión presencial junto con un CD con el material enseñado al grupo intervención. Anxious thoughts score in the Wells Anxiety Thoughts Questionnaire. Timepoint: Before the intervention began.At the beginning of the study (before the start of the intervention) and at the end of the intervention (8 weeks after the start of the intervention) and one month after the end of the intervention with Wells Anxiety Thought Questionnaire. Method of measurement: Wells Anxiety Thought Questionnaire. Ahvaz University of Medical Sciences Approved 2023-07-23 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Davood Davoodi Alley, Takhti Sq., Emam Ave. izeh Khouzestan Iran (Islamic Republic of)