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Enrolling by invitationNCT07187557Updated Nov 18, 2025

The Effect of Self-Compassion Based Birth Preparation Program

An interventional study of A self-compassion based birth preparation program in Pregnant Women, sponsored by Ordu University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Ordu University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

The pregnancy period, during which physiological, psychological and social changes occur, can negatively affect women mentally. It is stated that women's concerns about their own and their baby's health, anxiety and fear regarding birth, the uncertainty of the postpartum process and ambivalent feelings experienced cause negative mood changes. During pregnancy, body image dissatisfaction may develop due to weight gain, posture and skin changes, and this may cause women to experience depressive symptoms. Psychological changes such as depression, anxiety and stress experienced during pregnancy cause women to experience fear and anxiety regarding birth. Fear of birth, which is affected by many factors, also affects women's birth preferences and method. Fear of birth also affects women's psychological well-being in the postpartum period. Interventions are needed to ensure and maintain the psychological resilience of pregnant women. The aim of this study is to determine the effect of a self-compassion-based birth preparation program on self-compassion, body image, fear of birth, depression, anxiety and stress.

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Conditions studied

  • Pregnant Women
03

In context

Lead sponsor

Ordu University is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Those who are 18 years of age and older,

    • Those who have at least primary school education,
    • Those who understand and speak Turkish,
    • Those who reside within the borders of Ordu province,
    • Those who have no obstacle to vaginal birth,
    • Those who conceive naturally,
    • Those who have a singleton pregnancy,
    • Those who are 28 weeks or more pregnant,
    • Pregnant women who agree to participate in the study will be included.

Exclusion criteria

Exclusion Criteria:

  • - Those who have a history of risky pregnancies,
  • Those who have chronic and/or psychiatric health problems,
  • Those who have a cesarean section indication will not be included in the study. Exclusion criteria for the study
  • Those who are planned for a cesarean section due to medical indications at any stage of the study,
  • Those who do not attend at least three sessions of the education program,
  • Those who are at risk during the pregnancy at any stage of the study,
  • Pregnant women who start labor while the study is ongoing will be excluded from the study.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • No intervention
    Control group
  • Experimental
    A self-compassion based birth preparation program group

    A self-compassion based birth preparation program

    Other: A self-compassion based birth preparation program

Interventions

  • OtherA self-compassion based birth preparation program

    A self-compassion based birth preparation program

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What researchers measure

Primary outcomes

  1. The Effect of Self-Compassion Based Birth Preparation Program on Self-Compassion, Body Image, Fear of Childbirth, Depression, Anxiety and Stress in Pregnant Women

    This study aims to determine the effects of a self-compassion-based birth preparation program on self-compassion, body image, fear of childbirth, depression, anxiety and stress in pregnant women

    Time frame: from june 2025 to june 2026

  2. Personal Information Form

    Developed by the researchers based on literature, the form consists of questions regarding the socio-demographic and obstetric characteristics of pregnant women, such as their age, educational status, employment status, chronic disease status, number of pregnancies, gestational age, and number of children.

    Time frame: In the 28th week of pregnancy

  3. Self-Compassion Scale Short Form

    The Self-Compassion Scale Short Form, developed by Raes et al. (2011), is used to measure an individual's level of self-compassion. The scale was adapted into Turkish by Yıldırım and Sarı (2018). The single-dimension scale consists of 11 items and a 5-point Likert-type scale. High scores indicate high levels of self-compassion. The lowest possible score is 11, and the highest is 55. There is no cut-off score for the scale

    Time frame: At 28 weeks of pregnancy, after completing the program (4 weeks later) 1st month postpartum 3rd month postpartum

  4. Pregnancy Body Image Scale

    The Pregnancy Body Image Scale was developed by Watson et al. (2017) and adapted into Turkish by Gün Kakaşçı et al. (2022). As the total score on the scale increases, the perception of negative body image in pregnant women increases. The Cronbach's alpha coefficient for the entire scale was 0.90 and ranged from 0.65 to 0.94 for its subscales

    Time frame: At 28 weeks of pregnancy, after completing the program (4 weeks later)

  5. Wijma Childbirth Expectation/Experience Scale Version A

    This six-point Likert-type scale, consisting of 33 items covering childbirth-related fears, is scored from 0 to 5, with 0 being interpreted as completely and 5 being interpreted as not at all. The minimum score on the W-DEQ-A is 0, and the maximum score is 165. As women's scale scores increase, their fear of childbirth increases. W-DEQ-A scores are graded into four groups: mild fear of childbirth (W-DEQ-A score ≤37), moderate fear of childbirth (W-DEQ-A scores between 38 and 65), severe fear of childbirth (W-DEQ-A scores between 66 and 84), and clinical fear of childbirth (W-DEQ-A scores ≥85.

    Time frame: At 28 weeks of pregnancy, after completing the program (4 weeks later)

  6. Wijma Childbirth Expectation/Experience Scale Version B

    The Wijma Childbirth Expectation/Experience Scale Version B (W-DEQ-B) was developed by Wijma et al. (1998) to measure the fear of childbirth experienced by women after childbirth. The scale consists of 32 items. Responses are numbered from 0 to 5 and are a six-point Likert-type scale. 0 represents "completely," and 5 represents "not at all." The minimum score on the scale is 0, while the maximum score is 160.

    Time frame: first 24 hours after birth

  7. Depression Anxiety Stress Scale-21

    The Depression Anxiety Stress Scale-21 was developed by Lovibond and Lovibond (1995), and its Turkish validity and reliability study was conducted by Sarıçam (2018). The scale consists of 21 items, with 7 items each in the depression, anxiety, and stress subscales. It assesses depression, anxiety, and stress symptoms in the past week on a four-point scale from (0) never to (3) always. A score of 5 or higher on the depression subscale, 4 or higher on the anxiety subscale, and 8 or higher on the stress subscale indicates a relevant problem.

    Time frame: In the 28th week of pregnancy, After completing the program (4 weeks), 1st month postpartum, 3rd month postpartum

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Study locations

1 site
  • Ordu University
    Ordu, Ordu 52000, Turkey (Türkiye)
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References and documents

Study documents

  • Informed consent form · Sep 13, 2025
  • Informed consent form · Sep 13, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07187557
Lead sponsor
Ordu University
Responsible party
Hilal Gül Boyraz Yanik (Research Assistant, Ordu University) — Principal investigator
First posted
Sep 23, 2025
Start date
Sep 24, 2025
Primary completion
Jun 12, 2026 (estimated)
Completion
Jun 20, 2026 (estimated)
Last update
Nov 18, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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