- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07567755
Compassion-Based Breastfeeding Counseling and Its Effects on Self-Compassion, Mindful Breastfeeding, and Self-Efficacy (COMBFED)
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.
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Ankara
-
Ankara, Ankara, Turkki (Türkiye), 06000
- Gazi University Institute of Health Sciences, Ankara, Ankara 06000
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Literate or above
- Primigravida
- Between 18-35 years of age
- Between 24-28 weeks of gestation
- Spontaneous conception
- Owns a smartphone
Exclusion Criteria:
- 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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Intervention Group
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.
|
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.
|
|
Ei väliintuloa: Control Group
Receives routine antenatal care only, with no additional intervention.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Breastfeeding Self-Efficacy
Aikaikkuna: 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.
|
Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)
|
|
Self-Compassion
Aikaikkuna: 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.
|
Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)
|
|
Mindful Breastfeeding
Aikaikkuna: 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.
|
Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: ŞENGÜL YAMAN SÖZBİR, PhD, Gazi University, Faculty of Health Sciences, Department of Nursing
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2025 - 1341
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .