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

April 21, 2026 updated by: Mevhibe Coban, Inonu University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: not receiving self-compassion training
Experimental: self-compassion training
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-
Other: self-compassion training
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Self-compassion training will be applied to primiparas for 6 weeks to reduce stress.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Self-compassion training will be applied to primiparas for 6 weeks to increase comfort.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025/8004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The research was not concluded

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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