BreastfeedingCOMBFEDNCT07567755
Compassion-Based Breastfeeding Counseling and Its Effects on Self-Compassion, Mindful Breastfeeding, and Self-Efficacy
A study testing Compassion-Based Breastfeeding Counseling in people with Breastfeeding and Self-Compassion, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of compassion-based breastfeeding counseling on self-compassion, mindful breastfeeding, and breastfeeding self-efficacy during the perinatal period. Pregnant women between 24-28 weeks of gestation who meet the eligibility criteria are enrolled. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Self-Compassion, Perinatal Care
- What is being tested?
- Compassion-Based Breastfeeding Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literate or above
- Primigravida
- Between 18-35 years of age
- Between 24-28 weeks of gestation
- Spontaneous conception
- Owns a smartphone
Who cannot join
- Diagnosed with any psychiatric disorder (self-reported)
- High-risk pregnancy (preeclampsia, gestational diabetes mellitus, placenta previa, chronic disease, fetal anomaly, multiple pregnancy, Rh incompatibility, obesity)
- Previously attended any compassion or mindfulness-based training
- Communication barriers (inability to speak Turkish, hearing/speech impairment, or intellectual disability)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Institute of Health Sciences, Ankara, Ankara 06000
Ankara, Ankara, 06000
About this study
Official title: The Effect of Compassion-Based Breastfeeding Counseling During the Perinatal Period on Self-Compassion, Mindful Breastfeeding, and Breastfeeding Self-Efficacy
This randomized controlled trial aims to evaluate the effects of compassion-based breastfeeding counseling on self-compassion, mindful breastfeeding, and breastfeeding self-efficacy during the perinatal period.
Pregnant women between 24-28 weeks of gestation who meet the eligibility criteria are enrolled. After obtaining informed consent, participants are randomly assigned to either the intervention or control group using simple randomization.
Read more
The intervention group receives a total of 6 face-to-face compassion-based breastfeeding counseling sessions between 30-37 weeks of gestation, with follow-up counseling continued until 6 weeks postpartum. The control group receives only routine antenatal care with no additional intervention.
Outcome measures are assessed at three time points: pretest (24-28 weeks of gestation), posttest (36-38 weeks of gestation), and follow-up (6 weeks postpartum). Instruments used include the Self-Compassion Scale, the Breastfeeding Self-Efficacy Scale-Short Form, and the Mindful Breastfeeding Scale.
The study is conducted at Iğdır Dr. Nevruz Erez State Hospital, Türkiye.
Read the detailed description
Breastfeeding is the most effective intervention for protecting infant and maternal health. Despite its well-documented benefits, breastfeeding continuation rates decline over time due to insufficient support, breastfeeding difficulties, and psychosocial challenges in the postpartum period. Mothers experiencing breastfeeding problems may develop feelings of shame, failure, and inadequacy, which can negatively affect breastfeeding self-efficacy and increase the risk of early weaning.
Self-compassion - defined as treating oneself with kindness, acceptance, and non-judgment in the face of difficulties - has been associated with reduced depressive symptoms, increased psychological flexibility, and stronger mother-infant bonding in the perinatal period. Compassion-based breastfeeding counseling differs from traditional breastfeeding education by integrating emotional support, empathy, and psychosocial care alongside technical knowledge, thereby addressing both the informational and emotional needs of mothers.
This single-center, randomized controlled trial with a pretest-posttest-follow-up design is planned to assess the effectiveness of structured compassion-based breastfeeding counseling. Participants are pregnant women at 24-28 weeks of gestation attending Iğdır Dr. Nevruz Erez State Hospital. Eligible participants are randomly assigned to intervention (n=27) or control (n=27) groups. Sample size was calculated based on a power analysis (G*Power 3.1; repeated measures ANOVA, within-between interaction; partial η²=0.06; α=0.05; power=0.95) with a 20% dropout buffer.
The intervention consists of 6 structured face-to-face compassion-based breastfeeding counseling sessions delivered between 30-37 weeks of gestation, followed by counseling and follow-up support up to 6 weeks postpartum. The control group receives standard antenatal care only.
Outcome measures:
Self-Compassion Scale (Öz-Anlayış Ölçeği; Neff, 2003; Turkish adaptation: Deniz et al., 2008) - 24 items, 5-point Likert scale Breastfeeding Self-Efficacy Scale - Short Form (Dennis \& Faux, 1999; Turkish adaptation: Tokat Aluş et al., 2010) - 14 items, 5-point Likert scale Mindful Breastfeeding Scale (Körükcü et al., 2021) - 9 items, 5-point Likert scale
Assessment timepoints:
T0 (Pretest): 24-28 weeks of gestation T1 (Posttest): 36-38 weeks of gestation T2 (Follow-up): 6 weeks postpartum
Randomization is performed by an independent statistician using computer-generated allocation. Data analysis is conducted by a blinded independent statistician. Bias risk is assessed using the Cochrane Risk of Bias Tool (RoB 2). The study is reported in accordance with CONSORT guidelines.
- Conditions
- Breastfeeding, Self-Compassion, Perinatal Care
- Being tested
- Compassion-Based Breastfeeding Counseling
- Keywords
- Compassion-based counseling, Breastfeeding self-efficacy, Mindful breastfeeding, Self-compassion, Perinatal period, Randomized controlled trial, Antenatal education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-Based Breastfeeding CounselingBehavioural
A structured, compassion-based breastfeeding counseling program consisting of 6 face-to-face sessions delivered between 30-37 weeks of gestation. Each session integrates self-compassion practices (based on Neff's self-compassion model), mindfulness-based breastfeeding techniques, and evidence-based breastfeeding education. Sessions address emotional barriers to breastfeeding, strengthen breastfeeding self-efficacy, and promote mindful mother-infant interaction. Follow-up counseling is continued until 6 weeks postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Receives 6 face-to-face compassion-based breastfeeding counseling sessions between 30-37 weeks of gestation, with follow-up counseling continued until 6 weeks postpartum. Receives: Behavioral: Compassion-Based Breastfeeding Counseling |
| Control Group | No intervention | Receives routine antenatal care only, with no additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy
Measured by the Breastfeeding Self-Efficacy Scale-Short Form (Turkish adaptation, Tokat Aluş et al., 2010). 14-item, 5-point Likert scale; scores range 14-70. Higher scores indicate greater self-efficacy.
Measured: Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)
Self-Compassion
Measured by the Self-Compassion Scale (Turkish adaptation, Deniz et al., 2008). 24-item, 5-point Likert scale; scores range 24-120. Higher scores indicate greater self-compassion.
Measured: Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)
Mindful Breastfeeding
Measured by the Mindful Breastfeeding Scale (Körükcü et al., 2021). 9-item, 5-point Likert scale; scores range 9-45. Higher scores indicate greater mindfulness during breastfeeding.
Measured: Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 May 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Parallel groups
- Model description
- Participants are randomly assigned to either the intervention group (compassion-based breastfeeding counseling) or the control group (routine antenatal care) using simple randomization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Yaman Sözbir, Gazi University
- Investigators
- ŞENGÜL YAMAN SÖZBİR, PhD, Principal investigator, Gazi University, Faculty of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567755
- Sponsor's protocol ID
- 2025 - 1341
- Acronym
- COMBFED
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Compassion-Based Breastfeeding Counseling During the Perinatal Period on Self-Compassion, Mindful Breastfeeding, and Breastfeeding Self-Efficacy
- ClinicalTrials.gov ID
- NCT07567755
- Acronym / sponsor ID
- COMBFED / 2025 - 1341
- Conditions
- Breastfeeding, Self-Compassion, Perinatal Care
- Keywords
- Compassion-based counseling, Breastfeeding self-efficacy, Mindful breastfeeding, Self-compassion, Perinatal period, Randomized controlled trial, Antenatal education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 5 May 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.
This randomized controlled trial aims to evaluate the effects of compassion-based breastfeeding counseling on self-compassion, mindful breastfeeding, and breastfeeding self-efficacy during the perinatal period.
Pregnant women between 24-28 weeks of gestation who meet the eligibility criteria are enrolled. After obtaining informed consent, participants are randomly assigned to either the intervention or control group using simple randomization.
The intervention group receives a total of 6 face-to-face compassion-based breastfeeding counseling sessions between 30-37 weeks of gestation, with follow-up counseling continued until 6 weeks postpartum. The control group receives only routine antenatal care with no additional intervention.
Outcome measures are assessed at three time points: pretest (24-28 weeks of gestation), posttest (36-38 weeks of gestation), and follow-up (6 weeks postpartum). Instruments used include the Self-Compassion Scale, the Breastfeeding Self-Efficacy Scale-Short Form, and the Mindful Breastfeeding Scale.
The study is conducted at Iğdır Dr. Nevruz Erez State Hospital, Türkiye.
Detailed description
Breastfeeding is the most effective intervention for protecting infant and maternal health. Despite its well-documented benefits, breastfeeding continuation rates decline over time due to insufficient support, breastfeeding difficulties, and psychosocial challenges in the postpartum period. Mothers experiencing breastfeeding problems may develop feelings of shame, failure, and inadequacy, which can negatively affect breastfeeding self-efficacy and increase the risk of early weaning.
Self-compassion - defined as treating oneself with kindness, acceptance, and non-judgment in the face of difficulties - has been associated with reduced depressive symptoms, increased psychological flexibility, and stronger mother-infant bonding in the perinatal period. Compassion-based breastfeeding counseling differs from traditional breastfeeding education by integrating emotional support, empathy, and psychosocial care alongside technical knowledge, thereby addressing both the informational and emotional needs of mothers.
This single-center, randomized controlled trial with a pretest-posttest-follow-up design is planned to assess the effectiveness of structured compassion-based breastfeeding counseling. Participants are pregnant women at 24-28 weeks of gestation attending Iğdır Dr. Nevruz Erez State Hospital. Eligible participants are randomly assigned to intervention (n=27) or control (n=27) groups. Sample size was calculated based on a power analysis (G*Power 3.1; repeated measures ANOVA, within-between interaction; partial η²=0.06; α=0.05; power=0.95) with a 20% dropout buffer.
The intervention consists of 6 structured face-to-face compassion-based breastfeeding counseling sessions delivered between 30-37 weeks of gestation, followed by counseling and follow-up support up to 6 weeks postpartum. The control group receives standard antenatal care only.
Outcome measures:
Self-Compassion Scale (Öz-Anlayış Ölçeği; Neff, 2003; Turkish adaptation: Deniz et al., 2008) - 24 items, 5-point Likert scale Breastfeeding Self-Efficacy Scale - Short Form (Dennis \& Faux, 1999; Turkish adaptation: Tokat Aluş et al., 2010) - 14 items, 5-point Likert scale Mindful Breastfeeding Scale (Körükcü et al., 2021) - 9 items, 5-point Likert scale
Assessment timepoints:
T0 (Pretest): 24-28 weeks of gestation T1 (Posttest): 36-38 weeks of gestation T2 (Follow-up): 6 weeks postpartum
Randomization is performed by an independent statistician using computer-generated allocation. Data analysis is conducted by a blinded independent statistician. Bias risk is assessed using the Cochrane Risk of Bias Tool (RoB 2). The study is reported in accordance with CONSORT guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the intervention group (compassion-based breastfeeding counseling) or the control group (routine antenatal care) using simple randomization.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Compassion-Based Breastfeeding CounselingReceives 6 face-to-face compassion-based breastfeeding counseling sessions between 30-37 weeks of gestation, with follow-up counseling continued until 6 weeks postpartum. |
| Control Group | No intervention | –Receives routine antenatal care only, with no additional intervention. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Literate or above
- Primigravida
- Between 18-35 years of age
- Between 24-28 weeks of gestation
- Spontaneous conception
Key exclusion criteria (4 listed)
- Diagnosed with any psychiatric disorder (self-reported)
- High-risk pregnancy (preeclampsia, gestational diabetes mellitus, placenta previa, chronic disease, fetal anomaly, multiple pregnancy, Rh incompatibility, obesity)
- Previously attended any compassion or mindfulness-based training
- Communication barriers (inability to speak Turkish, hearing/speech impairment, or intellectual disability)
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 |
|---|---|---|
| Compassion-Based Breastfeeding CounselingA structured, compassion-based breastfeeding counseling program consisting of 6 face-to-face sessions delivered between 30-37 weeks of gestation. Each session integrates self-compassion practices (based on Neff's self-compassion model), mindfulness-based breastfeeding techniques, and evidence-based breastfeeding education. Sessions address emotional barriers to breastfeeding, strengthen breastfeeding self-efficacy, and promote mindful mother-infant interaction. Follow-up counseling is continued until 6 weeks postpartum. | Behavioural | Intervention Group |
Primary outcome
Breastfeeding Self-Efficacy
Time frame: Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)
Measured by the Breastfeeding Self-Efficacy Scale-Short Form (Turkish adaptation, Tokat Aluş et al., 2010). 14-item, 5-point Likert scale; scores range 14-70. Higher scores indicate greater self-efficacy.
Self-Compassion
Time frame: Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)
Measured by the Self-Compassion Scale (Turkish adaptation, Deniz et al., 2008). 24-item, 5-point Likert scale; scores range 24-120. Higher scores indicate greater self-compassion.
Mindful Breastfeeding
Time frame: Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)
Measured by the Mindful Breastfeeding Scale (Körükcü et al., 2021). 9-item, 5-point Likert scale; scores range 9-45. Higher scores indicate greater mindfulness during breastfeeding.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- 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. This study is not recruiting at the moment.
ŞENGÜL YAMAN SÖZBİR, PhD principal investigator
Gazi University, Faculty of Health Sciences, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion-Based Breastfeeding Counseling in people with Breastfeeding and Self-Compassion, run by Gazi 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 5 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Breastfeeding Self-Efficacy (time frame: Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)). The study lists 3 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 5 May 2026.