Mindfulness-Based Intervention in Primiparous Pregnant Women

NCT07660471 | Not Yet Recruiting

• 1 other identifier: PMI-2026-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effect of a mindfulness-based intervention on childbirth self-efficacy, fear of childbirth, and self-compassion among primiparous pregnant women. Eligible pregnant women will be randomly assigned to either a mindfulness intervention group or a control group receiving routine antenatal education and standard prenatal care. The intervention program will consist of eight sessions delivered over four weeks. Outcomes will be assessed before and after the intervention using validated measurement tools. The findings may contribute to the development of effective psychosocial interventions to improve maternal well-being during pregnancy.

Conditions

Pregnancy; Fear of Childbirth; Childbirth Self-efficacy; Self-Compassion

Keywords

Mindfulness; Mindfulness-Based Intervention; Pregnancy; Primiparous Pregnant Women; Fear of Childbirth; Childbirth Self-Efficacy; Self-Compassion; Maternal Mental Health; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• Childbirth Self-Efficacy

  Assessment of childbirth self-efficacy using the Childbirth Self-Efficacy Scale.

  Baseline and 4 weeks after intervention

• Fear of Childbirth

  Assessment of fear of childbirth using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A).

  Baseline and 4 weeks after intervention

• Self-Compassion

  Assessment of self-compassion using the Self-Compassion Scale.

  Baseline and 4 weeks after intervention

Study Arms (2)

Mindfulness-Based Intervention Group

EXPERIMENTAL

Participants in this group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, self-compassion, and mindfulness-based coping strategies for childbirth preparation.

Behavioral: Mindfulness-Based Intervention

Routine Antenatal Care Group

NO INTERVENTION

Participants will receive routine antenatal education and standard prenatal care. No mindfulness-based intervention will be administered.

Interventions

Mindfulness-Based Intervention BEHAVIORAL

A four-week mindfulness-based intervention consisting of eight sessions delivered twice weekly. The program includes breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion practices, and mindfulness-based coping strategies for childbirth preparation. Sessions will be delivered face-to-face and will last approximately 60-90 minutes each.

Mindfulness-Based Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women aged 18 years and older
• Primiparous women
• Singleton pregnancy
• Gestational age between 28 and 32 weeks
• No known obstetric complications
• Ability to read and understand Turkish
• Attendance at the Pregnancy School of the Healthy Life Center
• Willingness to participate and provide written informed consent
• Willingness to participate in the mindfulness-based intervention program

You may not qualify if:

• Multiple pregnancy
• High-risk obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa)
• Diagnosed severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)
• Substance or alcohol dependence
• Previous participation in a structured mindfulness, meditation, or similar awareness-based program
• Inability to attend intervention sessions regularly

Sponsors & Collaborators

• Agri Ibrahim Cecen University: lead

Study Sites (1)

Healthy Life Center Pregnancy School

Ağrı, Turkey (Türkiye)

Location

Related Publications (1)

• Feli R, Heydarpour S, Yazdanbakhsh K, Heydarpour F. The effect of mindfulness-based counselling on the anxiety levels and childbirth satisfaction among primiparous pregnant women: a randomized controlled trial. BMC Psychiatry. 2024 Dec 31;24(1):964. doi: 10.1186/s12888-024-06442-3.

  PMID: 39741245 RESULT

Related Links

• Related Info

Central Study Contacts

Ebru Solmaz, PhD

CONTACT

+905377737260; esolmaz@agri.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants and investigators are aware of group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Doctor

Model Details: Participants will be randomly assigned to one of two parallel groups. The intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions, while the control group will continue to receive routine antenatal education and standard prenatal care. Outcome measures will be assessed at baseline and after completion of the intervention.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)