Pregnancy RelatedSelfCompassionNCT07548528
The Effect of Mindfulness-Based Self-Compassion Training on Childbirth Fear, Pregnancy Stress, and Comfort in Primiparous Women
A study testing self-compassion training in people with Pregnancy Related, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- self-compassion training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2026to Aug 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mevhibe Çoban, PhD student contact
Turkey (Türkiye)1 site
Inonu University
Malatya, Malatya, 44000
ESRA GÜNEY, PhD, 05432064063, mevhibecoban@gmail.com
Mevhibe Çoban, PhD student, mevhibecoban@gmail.com
About this study
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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- self-compassion training
- Keywords
- fear of birth, midwife, pregnant, comfort, self-compassion, primiparous, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-compassion trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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- Receives: Other: self-compassion training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Self-compassion training will be applied to primiparas for 6 weeks to reduce stress.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- randomized controlled trial control and experimental group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mevhibe Coban, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548528
- Sponsor's protocol ID
- 2025/8004
- Acronym
- SelfCompassion
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research was not concluded
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Self-Compassion Training on Childbirth Fear, Pregnancy Stress, and Comfort in Primiparous Women
- ClinicalTrials.gov ID
- NCT07548528
- Acronym / sponsor ID
- SelfCompassion / 2025/8004
- Conditions
- Pregnancy Related
- Keywords
- fear of birth, midwife, pregnant, comfort, self-compassion, primiparous, stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 23 Apr 2026 (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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial control and experimental group
| Arm | Type | Receives |
|---|---|---|
| not receiving self-compassion training | No intervention | –not receiving self-compassion training |
| self-compassion training | Experimental | Other: self-compassion trainingAs 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- |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| self-compassion trainingAs 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 | Other | self-compassion training |
Primary outcome
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.
1 secondary outcome
Tilburg Pregnancy Distress Scale
Time frame: Self-compassion training will be applied to primiparas for 6 weeks to reduce stress.
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 23 Apr 2026.
- Comfort with motherhood in late pregnancy facilitates maternal role attainment in early postpartumLink provided by the sponsor.
- Individual participant dataSharing planned: No. The research was not concluded
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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.
Mevhibe Çoban, PhD student contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-compassion training in people with Pregnancy Related, run by Inonu 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Apr 2026. 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?
Contact ESRA GÜNEY, PhD (+905432064063, esra.guney@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 23 Apr 2026.