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IRCT20120215009014N619 IRCT 2026-07-25 Hamedan University of Medical Sciences Effect of group counseling based on dialectical behavior therapy compared to a control group on stress and sexual quality of life of pregnant women with a history of failed pregnancy Effect of group counseling based on dialectical behavior therapy compared to a control group on stress and sexual quality of life of pregnant women with a history of failed pregnancy: A randomized clinical trial 2026-08-23 anticipated 76 Recruiting https://irct.ir/trial/91889 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached. N/A Perceived stress. Intervention 1: Intervention group: Routine prenatal care plus group counseling sessions based on dialectical behavior therapy for 60 to 75 minutes, once a week for 6 weeks (including basic concepts of mindfulness and the chain model (stimulus, thoughts, emotion, physical response, behavior, and consequences), distress tolerance skills with special emphasis on managing thoughts related to the experience of a failed pregnancy, emotional regulation skills, identifying and naming emotions with an emphasis on non-sexual intimacy, effective communication skills, requesting support and co-regulation in the marital relationship, designing an immediate action plan to manage stressful situations, strengthening motivation to continue practicing and planning to maintain skills in the postpartum period, in all sessions, practical mindfulness exercises, radical acceptance, emotion regulation, and homework are continuously followed up.). Intervention 2: Control group: Routine prenatal 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 It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Fatemeh Arianfar
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 fatemeharianfar.1870422351@gmail.com Hamedan University of Medical Sciences scientific Dr. Seyedeh Zahra Masoumi
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 Zahramid2001@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 45 years, Gestational age 12 to 20 weeks, Pregnant woman with a history of failed pregnancy, Being literate, 18 years 45 years Female Drug addiction, Mental and psychiatric disorder, Neurological disease F43 Reaction to severe stress, and adjustment disorders Treatment - Other N/A Intervention group: Routine prenatal care plus group counseling sessions based on dialectical behavior therapy for 60 to 75 minutes, once a week for 6 weeks (including basic concepts of mindfulness and the chain model (stimulus, thoughts, emotion, physical response, behavior, and consequences), distress tolerance skills with special emphasis on managing thoughts related to the experience of a failed pregnancy, emotional regulation skills, identifying and naming emotions with an emphasis on non-sexual intimacy, effective communication skills, requesting support and co-regulation in the marital relationship, designing an immediate action plan to manage stressful situations, strengthening motivation to continue practicing and planning to maintain skills in the postpartum period, in all sessions, practical mindfulness exercises, radical acceptance, emotion regulation, and homework are continuously followed up.) Control group: Routine prenatal care Mean perceived stress score. Timepoint: Before intervention and 6 weeks after. Method of measurement: Using the Cohen Perceived Stress Questionnaire. Mean sexual quality of life score. Timepoint: Before intervention and 6 weeks after. Method of measurement: Using the Sexual Quality of Life Questionnaire. Hamedan University of Medical Sciences Approved 2026-07-25 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)