Pregnant WomenNCT07187557
The Effect of Self-Compassion Based Birth Preparation Program
A study testing A self-compassion based birth preparation program in people with Pregnant Women, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- A self-compassion based birth preparation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Self-Compassion Based Birth Preparation Program on Self-Compassion, Body Image, Fear of Childbirth, Depression, Anxiety and Stress in Pregnant Women
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.
- Conditions
- Pregnant Women
- Being tested
- A self-compassion based birth preparation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A self-compassion based birth preparation programOther
A self-compassion based birth preparation program
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| A self-compassion based birth preparation program group | Experimental | A self-compassion based birth preparation program Receives: Other: A self-compassion based birth preparation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from june 2025 to june 2026
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.
Measured: In the 28th week of pregnancy
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
Measured: At 28 weeks of pregnancy, after completing the program (4 weeks later) 1st month postpartum 3rd month postpartum
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
Measured: At 28 weeks of pregnancy, after completing the program (4 weeks later)
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.
Measured: At 28 weeks of pregnancy, after completing the program (4 weeks later)
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.
Measured: first 24 hours after birth
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.
Measured: In the 28th week of pregnancy, After completing the program (4 weeks), 1st month postpartum, 3rd month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start24 Sep 2025
- Primary completion12 Jun 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is an intervention and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Gül Boyraz Yanik, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187557
- Sponsor's protocol ID
- 07.02.2025/34
- Status last verified
- Nov 2025
- First submitted
- 11 Jun 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Compassion Based Birth Preparation Program on Self-Compassion, Body Image, Fear of Childbirth, Depression, Anxiety and Stress in Pregnant Women
- ClinicalTrials.gov ID
- NCT07187557
- Acronym / sponsor ID
- 07.02.2025/34
- Conditions
- Pregnant Women
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There is an intervention and control group.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| A self-compassion based birth preparation program group | Experimental | Other: A self-compassion based birth preparation programA self-compassion based birth preparation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Those who are 18 years of age and older,
Key exclusion criteria (7 listed)
- - 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A self-compassion based birth preparation programA self-compassion based birth preparation program | Other | A self-compassion based birth preparation program group |
Primary outcome
The Effect of 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
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
Personal Information Form
Time frame: In the 28th week of pregnancy
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.
Self-Compassion Scale Short Form
Time frame: At 28 weeks of pregnancy, after completing the program (4 weeks later) 1st month postpartum 3rd month postpartum
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
Pregnancy Body Image Scale
Time frame: At 28 weeks of pregnancy, after completing the program (4 weeks later)
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
Wijma Childbirth Expectation/Experience Scale Version A
Time frame: At 28 weeks of pregnancy, after completing the program (4 weeks later)
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.
Wijma Childbirth Expectation/Experience Scale Version B
Time frame: first 24 hours after birth
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.
Depression Anxiety Stress Scale-21
Time frame: In the 28th week of pregnancy, After completing the program (4 weeks), 1st month postpartum, 3rd month postpartum
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Preventing Postpartum Depression With Mindful Self-Compassion Intervention A Randomized Control StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A self-compassion based birth preparation program in people with Pregnant Women, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.