Mindfulness-Based Childbirth and Parenting Intervention and Prenatal Yoga on Birth Self-Efficacy, Fear of Childbirth, and Preferred Mode of Delivery in Primigravid Women

NCT07489781 | Active Not Recruiting DMC

• 1 other identifier: 2025-SBB-0951
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

(a) This thesis aims to examine the effects of counseling and prenatal yoga implemented within the scope of the Mindfulness-Based Childbirth and Parenting (MBCP) model on birth self-efficacy, fear of childbirth, and birth mode preferences among primigravid women. The planned study is expected to support the existing literature and constitutes an original contribution by addressing women's health from a holistic perspective. (b) This prospective randomized controlled study is planned to be conducted face-to-face between January 2026 and February 2027 at Medipol Ankara Hospital and Hacettepe University with a total of n = 164 pregnant women who volunteer to participate in the study and have no previous birth experience (control: 41; intervention-1 \[counseling based on the MBCP model\]: 41; intervention-2 \[prenatal yoga\]: 41; intervention-3 \[combined MBCP-based counseling and prenatal yoga\]: 41). Within the scope of the study, an 8-week intervention program including MBCP-based counseling and prenatal yoga will be implemented. Data will be collected using the Introductory Information Form developed in line with the literature, the Edinburgh Postnatal Depression Scale, the Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A), the Childbirth Self-Efficacy Inventory Short Form, the Fear of Childbirth Scale, and the Birth Mode Preference Scale. The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki, and the CONSORT checklist will be followed during the reporting process. (c) The thesis will be carried out by a doctoral student in the thesis phase and their advisor at the Department of Nursing, Institute of Health Sciences, Eskişehir Osmangazi University. (d) The findings of this thesis are expected to provide comprehensive evidence regarding the effects of MBCP-based counseling and prenatal yoga interventions on birth self-efficacy, fear of childbirth, and birth mode preferences among pregnant women. Furthermore, the results are anticipated to contribute significantly to academic, social, healthcare, and economic domains, and to support the strengthening of woman-centered care approaches in maternity services.

Conditions

Prenatal Yoga; Mindfulness-Based Childbirth; Parenting Counseling

Keywords

Birth Self-Efficacy; Fear of Childbirth; Delivery Mode; Primigravid Women

Outcome Measures

Primary Outcomes (3)

• Childbirth Self-Efficacy Inventory - Short Form (CBSEI-SF)

  Scores obtained from each subscale range between 16 and 160, while the total score ranges from 32 to 320. Higher scores indicate higher levels of childbirth self-efficacy and more positive outcome expectations. The scale is rated on a 10-point Likert scale. In the outcome expectancy subscale, responses range from 1 ("not at all helpful") to 10 ("very helpful"). In the efficacy expectancy subscale, items 1-13 are scored from 1 ("completely sure") to 10 ("not at all sure"), whereas the remaining items are scored from 1 ("not at all sure") to 10 ("completely sure"). The first 13 items of the efficacy expectancy subscale are reverse-coded.

  change from before implamentation patent and after 4st, and 8th week of practice

• Fear of Childbirth Scale (FOCS)

  The Fear of Childbirth Scale consists of 10 items. Participants are asked to rate each item on a scale from 1 ("strongly disagree") to 10 ("strongly agree"). Five items (items 1, 3, 5, 7, and 10) are positively worded, and five items (items 2, 4, 6, 8, and 9) are negatively worded. The positively worded items are reverse-coded.

  change from before implamentation patent and after 4st, and 8th week of practice

• Pregnant Women's Birth Mode Preference Scale

  The scale consists of 18 items and three subscales: self-efficacy, normative beliefs, and preferences. It is rated on a 5-point Likert scale. Higher scores indicate stronger tendencies and attitudes within the subscales. This scale is a valid and reliable instrument for assessing psychosocial factors influencing pregnant women's preferences regarding mode of delivery.

  change from before implamentation patent and after 4st, and 8th week of practice

Study Arms (4)

Control

NO INTERVENTION

Mindfulness-Based Childbirth

EXPERIMENTAL

Other: Mindfulness-Based Childbirth

Prenatal yoga

EXPERIMENTAL

Other: Prenatal yoga

Mindfulness-Based Childbirth and prenatal yoga

EXPERIMENTAL

Other: Prenatal yoga; Other: Mindfulness-Based Childbirth

Interventions

Prenatal yoga OTHER

Each group will consist of five (5) participants; however, due to the sample size, the final group will include six (6) participants. The prenatal yoga program is structured to last a total of eight weeks and will be conducted as two (2) sessions per week. Each session is planned to last approximately 75-90 minutes. The first 30 minutes of each session will consist of core prenatal yoga practices that will be applied consistently throughout all weeks. The remaining 45-60 minutes will include session components specifically structured for each week. The core components of the prenatal yoga program and the weekly session contents are presented in separate tables below to ensure standardization of the intervention and to enhance its reproducibility.

Mindfulness-Based Childbirth and prenatal yoga; Prenatal yoga

Mindfulness-Based Childbirth OTHER

Each group will consist of five (5) participants; however, due to the sample size, the final group will include six (6) participants. The Mindfulness-Based Childbirth and Parenting (MBCP) program is structured to last a total of eight weeks and will be conducted as two (2) sessions per week. Each session is planned to last approximately 60 minutes. The program will be implemented through core practices of the Mindfulness-Based Childbirth and Parenting model, along with session contents specifically structured for each week.

Mindfulness-Based Childbirth; Mindfulness-Based Childbirth and prenatal yoga

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteered to participate in the study,
• Were between 18 and 45 years of age,
• Were literate,
• Were between 22 and 28 weeks of gestation,
• Were primigravid,
• Had a singleton viable pregnancy,
• Were able to use a mobile phone or computer,
• Scored ≤12 on the Edinburgh Postnatal Depression Scale (EPDS),
• Had not previously received prenatal yoga training.

You may not qualify if:

• Conceived through assisted reproductive techniques (ART),
• Had a high-risk pregnancy,
• Were multiparous,
• Had a diagnosed psychiatric disorder or were receiving psychiatric treatment (as reported by the patient and/or physician),
• Had a mental condition such as intellectual disability or dementia that could interfere with cooperation (as reported by the patient and/or physician),
• Were currently participating in any individual or group psychotherapy or counseling program,
• Had visual or hearing impairments that could hinder communication.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: This thesis was designed as a prospective randomized controlled study.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: January 6, 2026
• Primary Completion: March 6, 2026
• Study Completion (Estimated): December 6, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

TU (1)