- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Elâzığ, Turkiet (Türkiye), 23100
- Family Health Centres (FHCs) in the provincial centre of Elazığ, Türkiye
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mindful Breastfeeding Scale
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- Kurt N, Uçar T, Effect of mindfulness-based breastfeeding education on breastfeeding outcomes: a randomized controlled trial. Manuscript in preparation.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2023/5132
- 966799 (Annan identifierare: fırat üniversitesi)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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