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IRCT20160608028352N15 IRCT 2025-12-02 Zanjan University of Medical Sciences The effect of mindfulness-based stress reduction counseling on stress and anxiety in women with positive results of prenatal screening tests The effect of mindfulness-based stress reduction counseling on stress and anxiety in women with positive results of prenatal screening tests 2025-11-11 anticipated 54 Complete https://irct.ir/trial/87088 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The researcher will recruit participants from women’s clinics. After explaining the study objectives and obtaining written informed consent, participants will be selected using convenience sampling. Once the samples are collected, participants will be assigned using random block allocation. Four-member blocks will be created, with half assigned to the intervention group and half to the control group. Participants will be coded from 01 to 54, and blocks will be selected using a random number table with six possible arrangements, continuing until the target sample size is reached (27 participants in the control group and 27 in the intervention group). N/A Condition 1: Stress. Condition 2: Anxiety. Intervention 1: Intervention group: MBSR sessions, conducted once a week. The researcher will participate in an MBSR training course and obtain a certification. In addition, the researcher will receive in-person supervision and training from the academic advisor, who is a psychologist. Intervention 2: Control group: Participants in the control group will receive only the routine prenatal care, and no interventions or counseling sessions will be conducted for them during the study period. After completion of the intervention phase, similar counseling sessions will be offered to the control group participants if they wish. Yes - There is a plan to make this available What will be shared: After the completion of the study, information regarding the primary and secondary outcomes will be shared. When: The access period will begin in mid-2026 To whom: The data and documentation will be made available to researchers in the field of medical sciences. Conditions: The data can be used for conducting studies, providing documentation, developing new ideas, and practical applications in educational centers. Where to obtain: Send an email to niloufar.jafari1996@gmail.com How to obtain: The data, after review and approval of the request, will be made available to the applicant within one month. Comments:
public Niloufar Jafari
Zanjan University of Medical Sciences, Gavazang Road
Zanjan Iran (Islamic Republic of) 4515613191 098 24 33148300 niloufar.jafari1996@gmail.com Zanjan University of Medical Sciences scientific Dr. Roghieh Kharaghani
جاده گاوازنگ، دانشگاه علوم پزشکی زنجان
Zanjan Iran (Islamic Republic of) 4515613191 +98 24 3314 8144 r.kharaghani@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Providing consent to participate in the study Pregnancy of less than 14 weeks Positive result in the first-trimester screening test Residency in Tehran Having at least basic reading and writing skills no limit no limit Female Presence of medical or psychological disorders Substance abuse Having a history of miscarriage or stillbirth in previous pregnancies Behavior Other Intervention group: MBSR sessions, conducted once a week. The researcher will participate in an MBSR training course and obtain a certification. In addition, the researcher will receive in-person supervision and training from the academic advisor, who is a psychologist. Control group: Participants in the control group will receive only the routine prenatal care, and no interventions or counseling sessions will be conducted for them during the study period. After completion of the intervention phase, similar counseling sessions will be offered to the control group participants if they wish. Stress. Timepoint: Before the intervention, immediately after the completion of the counseling sessions, and four weeks after the last counseling session. Method of measurement: Stress questions of the DASS-42 questionnaire (Depression, Anxiety, Stress Scale), which consists of 14 items. Anxiety. Timepoint: Before the intervention, immediately after the completion of the counseling sessions, and four weeks after the last counseling session. Method of measurement: Anxiety questions of the DASS-42 questionnaire (Depression, Anxiety, Stress Scale), which consists of 14 items. Mindfulness. Timepoint: Before the intervention, immediately after the completion of the counseling sessions, and four weeks after the last session. Method of measurement: FFMQ (Five Facet Mindfulness Questionnaire). Zanjan University of Medical Sciences Approved 2025-10-27 Ethics committee of Zanjan University of Medical Sciences North Side Azadi Boulevard Zanjan Zanjan Iran (Islamic Republic of)