Protocol summary
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Study aim
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To determine the effectiveness of virtual mindfulness-based counseling on self-efficacy and adjustment in women with unplanned pregnancy.
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Design
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This is a randomized controlled trial with parallel groups, conducted as an open-label study.
Eligible participants (n=98) will be assigned to the intervention group (virtual mindfulness-based counseling) or control group (standard prenatal care).
Randomization will be done using block randomization (blocks of four) via Random Allocation Software, with allocations placed in opaque, sealed, numbered envelopes to ensure concealment.
Blinding of participants and the researcher is not feasible.
Trial phase: Not Applicable (Non-pharmacological / Psychological intervention)
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Settings and conduct
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The study will be conducted in Babol County on women with unplanned pregnancies. Intervention sessions will be in-person and online. The control group will receive standard care.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Women with unplanned pregnancy; Maternal age 18–40 years old; Literacy (able to read and write); Access to a smartphone and the internet; Willingness to participate.
Exclusion Criteria: Severe physical or psychiatric disorders; High-risk pregnancy or history of high-risk pregnancy; Severe stressful events in the past three months; Unwillingness to continue participation; Absence from more than two counseling sessions; Miscarriage or pregnancy termination before intervention completion.
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Intervention groups
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Intervention Group (n=49):
Participants will receive virtual mindfulness-based counseling. The first session is in-person, and the remaining sessions are online.
Control Group (n=49):
Participants will receive standard prenatal care.
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Main outcome variables
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Maternal self-efficacy: Measured using the General Self-Efficacy Scale (GSE).
Adjustment to pregnancy: Measured using the Pregnancy Adjustment Questionnaire (PAQ).
General information
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Reason for update
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During the protocol update process, the start date of the patient's diagnosis was corrected. The date recorded in the previous version was incorrect due to an inadvertent error during data entry and has been replaced with the correct date.
Please review and confirm the change.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100510003902N8
Registration date:
2026-03-06, 1404/12/15
Registration timing:
prospective
Last update:
2026-08-12, 1405/05/21
Update count:
1
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Registration date
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2026-03-06, 1404/12/15
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2026-04-04, 1405/01/15
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Expected recruitment end date
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2027-05-22, 1406/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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“The Effectiveness of Virtual Mindfulness-Based Counseling on Self-Efficacy and Adjustment to Unplanned Pregnancy: A Randomized Clinical Trial”
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Public title
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“The Effect of Virtual Mindfulness-Based Counseling on Self-Efficacy and Adjustment of Women with Unplanned Pregnancy”
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
98
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2026-02-02, 1404/11/13
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Ethics committee reference number
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IR.MUBABOL.REC.1404.249
Health conditions studied
1
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Description of health condition studied
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Unwanted pregnancy
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ICD-10 code
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Z64.0
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ICD-10 code description
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Problems related to unwanted pregnancy
Primary outcomes
1
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Description
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Adjustment to pregnancy in pregnant women, assessed using the Pregnancy Self-Evaluation Questionnaire (PSEQ).
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Timepoint
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Baseline (at study entry) Post-intervention (after completion of sessions)
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Method of measurement
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Assessed using the Pregnancy Self-Evaluation Questionnaire (PSEQ)
Secondary outcomes
1
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Description
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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.
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Timepoint
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Baseline (at study entry)Post-intervention (after completion of sessions)
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Method of measurement
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Maternal self-efficacy: Assessed in pregnant women using the Pregnancy Self-Efficacy Questionnaire at baseline and post-intervention. Pregnancy outcomes will also be evaluated.
2
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Description
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Pregnancy outcome
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Timepoint
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Baseline، Monthly follow-up until delivery، At delivery
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Method of measurement
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Information is collected from the mother's medical record and monthly follow-up via phone call or text message until delivery.
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Control group: Participants in this group receive standard prenatal care according to local health guidelines, without any additional intervention or educational sessions.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available