- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07921485
The Effects of Hypnobreastfeeding and Oxytocin Massage on Breastfeeding (HBOM)
The Effect of Hypno-breastfeeding and Oxytocin Massage on Breastfeeding Motivation, Perceived Insufficient Milk Supply, Mother-to-Infant Bonding and Uterus Involution in Primiparas: A Randomized Controlled Trial
This study examined whether hypno-breastfeeding and oxytocin massage could improve breastfeeding motivation, mothers' perceptions of their milk supply, mother-to-infant bonding, and uterine recovery after childbirth in first-time mothers.
The study included 270 women at a public hospital in eastern Türkiye between September 2020 and March 2021. Participants were divided into three groups of 90 women each.
Women in the hypno-breastfeeding group received guidance on relaxation, positive affirmations, imagination, and visualization during late pregnancy and after childbirth. Women in the oxytocin massage group received two back massage sessions after childbirth. Women in the control group received routine care without either of these additional interventions.
On the first day after childbirth, the researchers assessed breastfeeding motivation, perceived milk supply, mother-to-infant bonding, and uterine recovery to compare the three groups.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
This study was conducted using a three-arm experimental design with a post-test control group at a public hospital in eastern Türkiye between September 2020 and March 2021. Data were collected by the researcher through face-to-face interviews with pregnant women attending the non-stress test (NST) unit and postpartum women admitted to the puerperal ward.
The study included 270 primiparous women, with 90 participants in each of three groups: hypno-breastfeeding, oxytocin massage, and routine care.
Pregnant women were recruited into the hypno-breastfeeding group according to their order of arrival at the NST unit. Postpartum women were assigned to the oxytocin massage or control group using a computer-based randomization procedure. A total of 180 numbered positions were generated for these two groups, with 90 women allocated to each group. Participants in the oxytocin massage and control groups were recruited from separate rooms to reduce the risk of infection.
The hypno-breastfeeding intervention began at 37-38 weeks of gestation and was repeated at 39-40 weeks. Participants received education and guidance on positive affirmations, relaxation, imagination, and visualization techniques, supported by educational materials, home exercises, telephone calls, and text messages. Two additional hypno-breastfeeding sessions were provided on the first postpartum day, before the first breastfeeding session and between 16 and 20 hours after childbirth.
Participants in the oxytocin massage group received two massage sessions on the first postpartum day, before the first breastfeeding session and between 16 and 20 hours after childbirth. The massage was performed in a quiet and private environment, focusing on the back and spinal region around the fifth and sixth ribs.
Participants in the control group received routine postpartum care without the study-specific hypno-breastfeeding or oxytocin massage interventions.
Outcome assessments were performed on the first postpartum day before hospital discharge. Breastfeeding motivation, perceived milk supply, and mother-to-infant bonding were evaluated using standardized questionnaires. Uterine recovery was assessed by measuring the distance between the uterine fundus and the symphysis pubis with a measuring tape after bladder emptying.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Malatya
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Malatya, Malatya, Turcja (Türkiye), 44280
- Malatya Training and Research Hospital - Women's, Maternity and Children's Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Study Inclusion Criteria:
For pregnants;
- Having a healthy singleton pregnancy of 37 weeks and above,
- Having no communication barrier,
- Having no diagnosed psychiatric issues. For puerperants;
- Having a normal delivery,
- Having no complications for herself and her baby in the postpartum period,
- Having consumed no herbal or other food/beverage to support breastfeeding in the postpartum period,
- Having no barriers to breastfeeding in the postpartum period (having a newborn in intensive care, having skin issues such as nipple cracks and inverted nipples, etc.),
- Having no communication barrier,
- Having no diagnosed psychiatric issues. Study Exclusion Criteria; For pregnants;
- Having developed cesarean section indication in delivery. For puerperants;
- Having any condition causing her to be separated from her baby in the postpartum period.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Hypno-breastfeeding Group
Participants received hypno-breastfeeding education and practice sessions during late pregnancy and on the first postpartum day. The intervention included relaxation, positive affirmations, imagination, and visualization techniques. |
The hypno-breastfeeding intervention was initiated at 37-38 weeks of gestation and repeated at 39-40 weeks during visits to the non-stress test (NST) unit. Participants received education and guidance on relaxation, positive affirmations, imagination, and visualization techniques to support breastfeeding. Educational brochures and home exercises were provided, and participants were supported through telephone calls and text messages. On the first postpartum day, two additional hypno-breastfeeding sessions were conducted: one before the first breastfeeding session and another between 16 and 20 hours after childbirth. |
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Eksperymentalny: Oxytocin Massage Group
Participants received two oxytocin massage sessions on the first postpartum day, before the first breastfeeding session and between 16 and 20 hours after childbirth. |
Participants received two oxytocin massage sessions on the first postpartum day. The first session was administered before the first breastfeeding session, and the second session was conducted between 16 and 20 hours after childbirth. The massage was performed in a quiet and private environment. Participants were seated in a forward-leaning position with their head resting on their arms or a table. Massage was applied to the back along the spinal region, particularly around the level of the fifth and sixth ribs, to support breastfeeding and postpartum recovery. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Breastfeeding Motivation Assessed Using the Primiparous Breastfeeding Motivation Scale (PBMS)
Ramy czasowe: Postpartum day 1, before hospital discharge.
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Breastfeeding motivation was assessed using the Primiparous Breastfeeding Motivation Scale (PBMS). Items are rated on a 7-point Likert scale. Subscale scores are calculated and interpreted separately, with higher scores indicating higher levels of the corresponding breastfeeding motivation dimension. No overall cut-off score is used. |
Postpartum day 1, before hospital discharge.
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Perceived Milk Supply Adequacy Assessed Using the Perceived Insufficient Milk Supply Questionnaire (PIMSQ)
Ramy czasowe: Postpartum day 1, before hospital discharge.
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Perceived milk supply adequacy was evaluated using the Perceived Insufficient Milk Supply Questionnaire (PIMSQ). Total scores range from 0 to 50, with higher scores indicating greater perceived milk supply adequacy and lower perceived insufficient milk supply. |
Postpartum day 1, before hospital discharge.
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Mother-to-Infant Bonding Assessed Using the Mother-to-Infant Bonding Scale (MIBS)
Ramy czasowe: Postpartum day 1, before hospital discharge.
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Mother-to-infant bonding was assessed using the Mother-to-Infant Bonding Scale (MIBS). Total scores range from 0 to 24, with higher scores indicating greater difficulties in mother-to-infant bonding. |
Postpartum day 1, before hospital discharge.
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Postpartum Uterine Fundal Height Measured Using the Uterine Involution Assessment Form (UIAF)
Ramy czasowe: Postpartum day 1, before hospital discharge.
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Postpartum uterine involution was assessed using a researcher-developed Uterine Involution Assessment Form (UIAF). After the participant emptied her bladder, the distance between the uterine fundus and the symphysis pubis was measured in centimeters using a measuring tape. The same measuring tape was used for all assessments. The recorded measurement represented uterine fundal height on the first postpartum day. |
Postpartum day 1, before hospital discharge.
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- References 1. J. Stockdale, M. Sinclair, G. Kernohan, et al. Understanding motivational theory and the psychology of breastfeeding. In: Bryar R, Sinclair M (eds), Theory for midwifery practice: Palgrave Macmillan, 2011. 2. J. Stockdale, M. Sinclair, G. Kernohan, et al. Sensitivity of the breastfeeding motivational measurement scale: a known group analysis of first time mothers, PloS one 2013;8(12), e82976. 3. E. Koc, S. Ruzgar, S. Ozturk Altinayak, Determination of Factors affecting lactating women's perceptions of ınsufficient milk and the foods they use to ıncrease breast milk, Bezmialem Science 2024;12(3):280-7. https://doi.org/10.14235/bas.galenos.2024.56933 4. S.G. Caliskan, S. Altinkaynak, I'm Breastfeeding My Baby Doesn't Get Enough: Perception of Insufficient Milk, Sakarya University Journal of Holistic Health 2019;2(2), 1-9. 5. S. Ucan, The Effect of Breastfeeding Education Given to Parents on Breastfeeding Process, Cultural Behaviors and Parent-Infant Attachment. Institute of Health Sciences, Department of Public Health. PhD Thesis, Konya: Selcuk University, 2016. 6. E. Bianciardi, F. Ongaretto, A. De Stefano, et al., The mother-baby bond: Role of past and current relationships, Children 2023;10(3), 421. https://doi.org/10.3390/children10030421 7. G. Bosmans, L. Van Vlierberghe, M.J. Bakermans-Kranenburg, et al., A learning theory approach to attachment theory: Exploring clinical applications, Clinical child and family psychology review 2022;25(3), 591-612. https://doi.org/10.1007/s10567-021-00377-x 8. S. Topal, N. Çınar, S. Altınkaynak, Maternal Health Benefits of Breastfeeding, Journal of Human Rhythm 2017;3(1), 25-31. 9. K.A. Uctu, N. Ozerdoğan, Effect of teach-back method on breastfeeding success: A single blind randomized controlled study, Health Care for Women International 2023;44:3, 314-327, https://doi.org/10.1080/07399332.2021.201915 10. N. Irmak, Importance of breast milk and factors affecting exclusive breastfeeding for the first 6 months,
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HBOM-2020-001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data (IPD) will not be shared with other researchers due to participant confidentiality and privacy considerations. The study data will be retained and managed in accordance with the approved research protocol and applicable ethical requirements.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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