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NCT Number: NCT07548528

The Effect of Mindfulness-Based Self-Compassion Training on Childbirth Fear, Pregnancy Stress, and Comfort in Primiparous Women

The purpose of this study was to determine the effects of mindfulness-based self-compassion training provided to primiparous women on fear of childbirth, pregnancy stress, and comfort.

Research Hypotheses H1a: Mindfulness-based self-compassion training provided to primiparous women reduces fear of childbirth.

H1b: Mindfulness-based self-compassion training provided to primiparous women reduces pregnancy stress.

H1c: Mindfulness-based self-compassion training provided to primiparous women increases comfort.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The research will be conducted as a randomized controlled experimental study. The research is planned to be conducted at the Pregnancy School of Sincan Training and Research Hospital between August 1, 2025 and August 1, 2026. Sincan Training and Research Hospital has eight obstetrics and gynecology outpatient clinics, each staffed by one doctor, one midwife, and one medical secretary. The hospital also has one prenatal school, which provides prenatal education for pregnant women. Two midwives work at the prenatal school. Patient privacy will be protected throughout the research period.

The study population will consist of primiparous women applying to the Pregnancy School of Sincan Training and Research Hospital. The study sample was determined using the G*Power 3.1.9.7 program. In the power analysis, a large effect size (d=0.80) was used, based on the effect size range table reported by Cohen (11). According to the calculation; With an effect size of d = 0.80, a margin of error of 0.05 (α = 0.05), a confidence level of 0.95 (1-α), and a representativeness of 0.95 for the universe (1-β = 0.95), the sample size was calculated as at least 36 women for each group (SExperiment = 36, SControl = 36), a total of 72 women, including the experimental and control groups. When the dropout rate in the study was evaluated as 10%, it was decided to include a total of 80 women in each group (SExperiment = 40, SControl = 40). Women who agreed to participate in the study and met the inclusion criteria will be assigned to the experimental and control groups using the simple randomization method. The sampling process of the study will be carried out based on CONSORT criteria.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged between 18 and 45, Women who are pregnant for the first time, Women who live with their partner, Women who are 28 weeks or older in pregna

Exclusion criteria

  • Women with multiple pregnancies, Women with any communication disorder, Women with a diagnosed psychiatric disorder, Women who have any health problems during pregnancy (such as hypertension, gestational diabetes, etc.) will be excluded from the study.

Treatment and study plan

self-compassion training

Other

As a midwifery intervention, primiparous women in the experimental group were provided with mindfulness-based self-compassion training. The self-compassion training program consisted of encouraging women to be kind and understanding toward themselves, recognizing that suffering is a part of human life and that being present in the here and now contributes to the human spirit and consciousness, providing a discussion environment for sharing their experiences, and homework assignments related to the program content. The researcher conducted an eight-week mindfulness-based self-compassion training. The training program will be conducted in six sessions, using face-to-face meetings at the pregnancy school. While the duration of each session will vary depending on the women's compliance and needs, each session is planned to last approximately 30-40 minutes. The mindfulness-based self-compassion training will be implemented by the researcher. Each session will cover an introduction to self-c

Primary outcomes

  1. Description: Wijma Childbirth Expectation/Experience Scale Version A

    Time frame: Self-compassion training will be provided to primiparous women in six sessions to reduce fear of childbirth and pregnancy stress and increase comfort.

    Wijma Childbirth Expectation/Experience Scale Version A The W-DEQ version A is a 33-item scale with six Likert-type scales. Responses are numbered from zero to five. Zero represents "completely," and five represents "not at all." The maximum possible score is 0, with a maximum score of 165. It is assumed that the level of fear of childbirth increases as the total scale score increases.

Secondary outcomes

  1. Tilburg Pregnancy Distress Scale

    Time frame: Self-compassion training will be applied to primiparas for 6 weeks to reduce stress.

    This scale, which can be administered to pregnant women 12 weeks or more, consists of 16 items and is scored on a 4-point Likert scale (0 points for very often, 1 point for quite often, 2 points occasionally, and 3 points for rarely/never). The total score obtained from the scale ranges from 0 to 48. A cut-off score of 28 or higher indicates that the pregnant woman is at risk for distress.

Other outcomes

  1. Prenatal Comfort Scale

    Time frame: Self-compassion training will be applied to primiparas for 6 weeks to increase comfort.

    Prenatal Comfort Scale The scale consists of 15 items and 5 subscales. The subscales are: "Impact of developing relationships with spouse on the paternal role - Spouse," "Interacting with fetal movements - Fetus," "Social support received from people around - Social Environment," "Acceptance of the maternal role and attachment to the baby - Motherhood," and "Noticing changes in oneself during pregnancy - Pregnancy." The scale is a 6-point Likert-type scale. Each item is scored from 0 to 5 (0 = Strongly disagree, 1 = Disagree, 2 = Undecided, 3 = Somewhat agree, 4 = Agree, 5 = Strongly agree). The scale is evaluated out of a total of 75 points. A lower score indicates a lower level of comfort, while a higher score indicates a higher level of comfort.

Study contacts

Contact information is provided by the study sponsor or research team.

ESRA GÜNEY, PhD

CONTACT

[email protected]

+905432064063

Mevhibe Çoban, PhD student

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Acronym: SelfCompassion

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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