- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07647211
MINDFULNESS-BASED BREASTFEEDING EDUCATION PROGRAM (MIND-BF)
EFFECT OF MINDFULNESS-BASED BREASTFEEDING EDUCATION PROGRAM ON BREASTFEEDING OUTCOMES IN MOTHERS NOT EXCLUSIVELY BREASTFEEDING: A RANDOMIZED CONTROLLED TRIAL
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Breastfeeding is one of the most important practices for improving maternal and infant health. However, many mothers experience difficulties maintaining exclusive breastfeeding during the postpartum period. Psychological stress, anxiety, low breastfeeding confidence, and difficulties adapting to motherhood may negatively affect breastfeeding behaviors and contribute to early supplementation with formula or other foods.
Mindfulness-based approaches have been increasingly used to support maternal psychological well-being and health-related behaviors. These approaches aim to increase awareness of present-moment experiences in a non-judgmental manner and may help mothers engage more consciously in the breastfeeding process. Previous studies suggest that mindfulness-based interventions may improve maternal coping, emotional regulation, and breastfeeding experiences. However, evidence regarding their effectiveness among mothers who are not exclusively breastfeeding remains limited.
This randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding awareness, breastfeeding self-efficacy, and exclusive breastfeeding rates among postpartum mothers who are not exclusively breastfeeding. Participants are randomly assigned to either a mindfulness-based breastfeeding education group or a control group receiving routine postpartum care. The intervention includes structured breastfeeding education combined with mindfulness-based practices conducted over four weeks. Outcomes are assessed at baseline, immediately after the intervention, and during follow-up assessments postpartum.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Elâzığ, Tyrkia (Türkiye), 23100
- Family Health Centres (FHCs) in the provincial centre of Elazığ, Türkiye
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Being 18 years of age or older, being in the first month postpartum, having a full-term, singleton, and healthy infant, and not exclusively breastfeeding the infant (i.e., using formula or other foods in addition to breast milk)
Exclusion Criteria:
- Having previously received mindfulness or similar training, having a diagnosed psychiatric disorder, and having any condition that impairs communication.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Mindfulness-Based Breastfeeding Education Group
Participants received a 4-week mindfulness-based breastfeeding education program consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife.
The program combined breastfeeding education with mindfulness-based stress reduction techniques (breathing meditation, body scan, sitting meditation, mountain meditation, and loving-kindness meditation).
Practical breastfeeding training was supported using a doll and breast model.
Participants also received audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice, in addition to routine postpartum care.
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A 4-week mindfulness-based breastfeeding education program was implemented, consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife.
The intervention combined breastfeeding education with mindfulness-based stress reduction techniques, including breathing meditation, body scan meditation, sitting meditation, mountain meditation, and loving-kindness (Metta) meditation.
Practical breastfeeding training was provided using a doll and breast model to support skill acquisition.
Participants were also given audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice in addition to routine postpartum care.
Andre navn:
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Ingen inngripen: Control Group
Participants received routine postpartum follow-up and standard breastfeeding counseling provided at Family Health Centres.
No additional mindfulness-based intervention was administered.
Counseling included brief education and support related to breastfeeding as part of standard care.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mindful Breastfeeding Scale
Tidsramme: Baseline, 4th week postpartum, 4th month postpartum
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This is a 9-item measurement tool designed to assess awareness-based breastfeeding practices during the postpartum period.
The scale is unidimensional and was developed using a 5-point Likert scale.
Responses to the scale items range from "always" to "never."
The total score on the scale ranges from 9 to 45, and as the total score increases, the level of awareness regarding breastfeeding also increases.
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Baseline, 4th week postpartum, 4th month postpartum
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kurt N, Uçar T, Effect of mindfulness-based breastfeeding education on breastfeeding outcomes: a randomized controlled trial. Manuscript in preparation.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2023/5132
- 966799 (Annen identifikator: fırat üniversitesi)
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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