NCT07548528

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Apr 2026Aug 2026

Study Start

First participant enrolled

April 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 16, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

fear of birthmidwifepregnantcomfortself-compassionprimiparousstress

Outcome Measures

Primary Outcomes (1)

  • Description: Wijma Childbirth Expectation/Experience Scale Version A

    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 Outcomes (1)

  • Tilburg Pregnancy Distress Scale

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

Other Outcomes (1)

  • Prenatal Comfort Scale

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

Study Arms (2)

not receiving self-compassion training

NO INTERVENTION

not receiving self-compassion training

self-compassion training

EXPERIMENTAL

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

Interventions

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

self-compassion training

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsprimipar
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Malatya, 44000, Turkey (Türkiye)

Location

Related Links

Central Study Contacts

Mevhibe Çoban, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: randomized controlled trial control and experimental group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 23, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The research was not concluded

Locations