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IRCT20100510003902N8 IRCT 2026-03-06 Babol University of Medical Sciences “The Effect of Virtual Mindfulness-Based Counseling on Self-Efficacy and Adjustment of Women with Unplanned Pregnancy” “The Effectiveness of Virtual Mindfulness-Based Counseling on Self-Efficacy and Adjustment to Unplanned Pregnancy: A Randomized Clinical Trial” 2026-04-04 anticipated 98 Recruiting https://irct.ir/trial/88684 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To prevent allocation bias, randomization will be performed by an independent statistician. The random sequence will be generated using block randomization (blocks of four) with Random Allocation Software (Saghaei, 2004). Allocation numbers will be placed in opaque, sealed, and sequentially numbered envelopes to ensure allocation concealment. After each eligible participant provides written informed consent, the researcher will open the corresponding envelope and assign the participant to either the intervention group (n=49) or the control group (n=49). N/A Unwanted pregnancy. Intervention 1: Intervention Group:Participants receive mindfulness-based counseling consisting of one in-person session and seven online sessions via social networks (Eitaa, WhatsApp, Google Meet). Each session lasts 90 minutes and occurs weekly.All sessions are conducted by a Master’s student in Midwifery Counseling, trained in Mindfulness-Based Interventions. Session content is based on validated scientific protocols and reviewed by a psychiatrist and research team. The intervention is supervised by the principal investigator and a psychiatric advisor to ensure consistency and participant safety.Session structure:• Session 1: Interactive mindfulness training, body scan meditation, homework: mindful raisin exercise and body scan.• Session 2: Thoughts and feelings exercises, seated meditation and mindful walking, homework: record pleasant events and practice meditation.• Session 3: Body mindfulness and 3-minute breathing space, mindfulness in daily activities, homework: selected meditation practice.• Session 4: Four-dimensional meditation, seeing and hearing exercises, homework: self-care planning and pleasant activity schedule.• Sessions 5–8: Review and practice of previous techniques, seated and four-dimensional meditation, practical exercises and homework, online feedback and practice tracking.All assessments are conducted pre- and post-intervention, and educational links are also provided to the control group after the study to ensure educational fairness. Intervention 2: Control group: Participants in this group receive standard prenatal care according to local health guidelines, without any additional intervention or educational sessions. 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 No final decision has been made regarding sharing de-identified individual participant data, and the plan for its release is not yet determined.
public Farideh mohsenzadeh ledari
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 5323 mohsenzadh2008@gmail.com Babol University of Medical Sciences scientific Farideh Mohsenzadeh Ledari
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 5323 mohsenzadh2008@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Pregnant women with unplanned pregnancy, based on the definition of the World Health Organization (WHO, 2021). Gestational age between 12 and 28 weeks (based on ultrasound examination or prenatal care records). Ability to read and write (literacy). Willingness to participate in the study. No history of chronic physical diseases (such as insulin-dependent diabetes mellitus or severe cardiovascular disease). Maternal age between 18 and 40 years. Access to a smartphone and the internet. Singleton pregnancy. Residence in Babol County and ability to attend counseling sessions (first session in person and subsequent sessions virtually). Provision of written informed consent to participate in the study 18 years 40 years Female Severe psychiatric disorders (based on health records or physician report) History of high-risk pregnancy (such as preeclampsia, gestational diabetes, or preterm delivery in previous pregnancies). Experience of severe stressful events in the past three months (such as death of a close relative or divorce). Unwillingness to continue participation at any stage of the study. Absence from more than two counseling sessions Occurrence of miscarriage or termination of pregnancy before the end of the intervention Z64.0 Problems related to unwanted pregnancy Behavior N/A Intervention Group:Participants receive mindfulness-based counseling consisting of one in-person session and seven online sessions via social networks (Eitaa, WhatsApp, Google Meet). Each session lasts 90 minutes and occurs weekly.All sessions are conducted by a Master’s student in Midwifery Counseling, trained in Mindfulness-Based Interventions. Session content is based on validated scientific protocols and reviewed by a psychiatrist and research team. The intervention is supervised by the principal investigator and a psychiatric advisor to ensure consistency and participant safety.Session structure:• Session 1: Interactive mindfulness training, body scan meditation, homework: mindful raisin exercise and body scan.• Session 2: Thoughts and feelings exercises, seated meditation and mindful walking, homework: record pleasant events and practice meditation.• Session 3: Body mindfulness and 3-minute breathing space, mindfulness in daily activities, homework: selected meditation practice.• Session 4: Four-dimensional meditation, seeing and hearing exercises, homework: self-care planning and pleasant activity schedule.• Sessions 5–8: Review and practice of previous techniques, seated and four-dimensional meditation, practical exercises and homework, online feedback and practice tracking.All assessments are conducted pre- and post-intervention, and educational links are also provided to the control group after the study to ensure educational fairness. Control group: Participants in this group receive standard prenatal care according to local health guidelines, without any additional intervention or educational sessions. Adjustment to pregnancy in pregnant women, assessed using the Pregnancy Self-Evaluation Questionnaire (PSEQ). Timepoint: Baseline (at study entry) Post-intervention (after completion of sessions). Method of measurement: Assessed using the Pregnancy Self-Evaluation Questionnaire (PSEQ). Maternal self-efficacy: The level of maternal self-efficacy in coping with pregnancy, measured using the Pregnancy Self-Efficacy Questionnaire. Assessments are conducted at baseline and immediately after the completion of the intervention. Timepoint: Baseline (at study entry)Post-intervention (after completion of sessions). Method of measurement: Maternal self-efficacy: Assessed in pregnant women using the Pregnancy Self-Efficacy Questionnaire at baseline and post-intervention. Pregnancy outcomes will also be evaluated. Pregnancy outcome. Timepoint: Baseline، Monthly follow-up until delivery، At delivery. Method of measurement: Information is collected from the mother's medical record and monthly follow-up via phone call or text message until delivery. Babol University of Medical Sciences Approved 2026-02-02 Health Research Institute - Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afroz Street Babol Mazandaran Iran (Islamic Republic of)