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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05921669
Other study ID # EskisehirOU-IKARANFIL-001-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date November 1, 2023

Study information

Verified date June 2023
Source Eskisehir Osmangazi University
Contact Ilfan Karanfil
Phone 05399819464
Email ilfan.koksal@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The most suitable food for babies is breast milk. It is known that breastfeeding, beyond providing nutrition, has many health benefits for the baby and the mother. The World Health Organization (WHO) recommends that babies start breastfeeding within 1 hour after birth and breastfeed exclusively without any additional food, including water, for the first 6 months. After six months, complementary foods should be started, and the baby should continue to be breastfed for two years or more. On the other hand, between 2015-2020, the rates of infants aged 0-6 months fed with breast milk alone are approximately 44% worldwide. There are many factors that affect the time of initiation of breastfeeding and the duration of breastfeeding. Some of those; maternal education, mode of delivery, birth weight and socio-economic status. Another influential factor is paternal support. Fathers may want to be involved in breastfeeding education and support their spouses in this process. However, the reasons such as not taking part in the trainings and not being asked direct questions about breastfeeding may cause fathers to feel excluded in this process. It is important to include fathers in education and interventions to achieve breastfeeding goals. Mothers who are supported by their spouses during the breastfeeding process experience breastfeeding problems less and can cope with these problems better. Today, it is known that fathers are not given sufficient importance in promoting breastfeeding. Including fathers in breastfeeding education can increase the rate and duration of breastfeeding of infants. This study was planned to determine the effect of breastfeeding education given to mothers and/or fathers in the postnatal period on breastfeeding, parent-infant attachment and breastfeeding self-efficacy. The aim of the study is to draw attention to the importance of father support in breastfeeding.


Recruitment information / eligibility

Status Recruiting
Enrollment 105
Est. completion date November 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Parent's consent to participate in the research - Parents must be at least primary school graduates - Mothers and fathers to participate in the study must be 20 years or older - The mother's first pregnancy (primiparous pregnant) - Having a smart mobile phone of the mother and father - The baby is born at term Exclusion Criteria: - Experiencing communication problems with parents (mother and father cannot speak and/or understand Turkish, etc.) - Having or developing a health problem in the mother or baby - Separation of the mother from her baby for any reason after birth

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Provide breastfeeding education
Providing breastfeeding education within the first 24 hours after birth

Locations

Country Name City State
Turkey Eskisehir Osmangazi Üniversitesi Saglik Bilimleri Fakültesi Eskisehir

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (23)

Abbass-Dick J, Dennis CL. Breast-feeding Coparenting Framework: A New Framework to Improve Breast-feeding Duration and Exclusivity. Fam Community Health. 2017 Jan/Mar;40(1):28-31. doi: 10.1097/FCH.0000000000000137. — View Citation

Abbass-Dick J, Stern SB, Nelson LE, Watson W, Dennis CL. Coparenting breastfeeding support and exclusive breastfeeding: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):102-10. doi: 10.1542/peds.2014-1416. Epub 2014 Dec 1. — View Citation

Abbass-Dick J, Xie F, Koroluk J, Alcock Brillinger S, Huizinga J, Newport A, Goodman WM, Dennis CL. The Development and piloting of an eHealth breastfeeding resource targeting fathers and partners as co-parents. Midwifery. 2017 Jul;50:139-147. doi: 10.1016/j.midw.2017.04.004. Epub 2017 Apr 18. — View Citation

Bennett AE, McCartney D, Kearney JM. Views of fathers in Ireland on the experience and challenges of having a breast-feeding partner. Midwifery. 2016 Sep;40:169-76. doi: 10.1016/j.midw.2016.07.004. Epub 2016 Jul 4. — View Citation

Beyene AM, Liben ML, Arora A. Factors associated with the early termination of exclusive breastfeeding among mother-infant dyads in Samara-Logia, Northeastern Ethiopia. BMC Pediatr. 2019 Nov 11;19(1):428. doi: 10.1186/s12887-019-1803-1. — View Citation

Brown A, Davies R. Fathers' experiences of supporting breastfeeding: challenges for breastfeeding promotion and education. Matern Child Nutr. 2014 Oct;10(4):510-26. doi: 10.1111/mcn.12129. Epub 2014 Apr 10. — View Citation

Cakirli M, Acikgoz A. A Randomized Controlled Trial: The Effect of Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor on Pain Level of Newborn Infants. Breastfeed Med. 2021 Jan;16(1):75-81. doi: 10.1089/bfm.2020.0222. Epub 2020 Oct 20. — View Citation

Dennis CL, Brennenstuhl S, Abbass-Dick J. Measuring paternal breastfeeding self-efficacy: A psychometric evaluation of the Breastfeeding Self-Efficacy Scale-Short Form among fathers. Midwifery. 2018 Sep;64:17-22. doi: 10.1016/j.midw.2018.05.005. Epub 2018 May 15. — View Citation

Dennis CL, Faux S. Development and psychometric testing of the Breastfeeding Self-Efficacy Scale. Res Nurs Health. 1999 Oct;22(5):399-409. doi: 10.1002/(sici)1098-240x(199910)22:53.0.co;2-4. — View Citation

Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459. — View Citation

Ingram J, Johnson D. A feasibility study of an intervention to enhance family support for breast feeding in a deprived area in Bristol, UK. Midwifery. 2004 Dec;20(4):367-79. doi: 10.1016/j.midw.2004.04.003. — View Citation

Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x. — View Citation

Kucukoglu S, Sezer HK, Dennis CL. Validity and reliability of the Turkish version of the paternal breastfeeding self-efficacy scale - Short form for fathers. Midwifery. 2023 Jan;116:103513. doi: 10.1016/j.midw.2022.103513. Epub 2022 Oct 22. — View Citation

Maycock B, Binns CW, Dhaliwal S, Tohotoa J, Hauck Y, Burns S, Howat P. Education and support for fathers improves breastfeeding rates: a randomized controlled trial. J Hum Lact. 2013 Nov;29(4):484-90. doi: 10.1177/0890334413484387. Epub 2013 Apr 19. — View Citation

Ogbo FA, Akombi BJ, Ahmed KY, Rwabilimbo AG, Ogbo AO, Uwaibi NE, Ezeh OK, Agho KE, On Behalf Of The Global Maternal And Child Health Research Collaboration GloMACH. Breastfeeding in the Community-How Can Partners/Fathers Help? A Systematic Review. Int J Environ Res Public Health. 2020 Jan 8;17(2):413. doi: 10.3390/ijerph17020413. — View Citation

Ozluses E, Celebioglu A. Educating fathers to improve breastfeeding rates and paternal-infant attachment. Indian Pediatr. 2014 Aug;51(8):654-7. doi: 10.1007/s13312-014-0471-3. — View Citation

Pisacane A, Continisio GI, Aldinucci M, D'Amora S, Continisio P. A controlled trial of the father's role in breastfeeding promotion. Pediatrics. 2005 Oct;116(4):e494-8. doi: 10.1542/peds.2005-0479. — View Citation

Rempel LA, Rempel JK, Moore KCJ. Relationships between types of father breastfeeding support and breastfeeding outcomes. Matern Child Nutr. 2017 Jul;13(3):e12337. doi: 10.1111/mcn.12337. Epub 2016 Jul 27. — View Citation

Smith MM, Durkin M, Hinton VJ, Bellinger D, Kuhn L. Initiation of breastfeeding among mothers of very low birth weight infants. Pediatrics. 2003 Jun;111(6 Pt 1):1337-42. doi: 10.1542/peds.111.6.1337. — View Citation

Su M, Ouyang YQ. Father's Role in Breastfeeding Promotion: Lessons from a Quasi-Experimental Trial in China. Breastfeed Med. 2016 Apr;11:144-9. doi: 10.1089/bfm.2015.0144. Epub 2016 Feb 2. — View Citation

Susin LR, Giugliani ER. Inclusion of fathers in an intervention to promote breastfeeding: impact on breastfeeding rates. J Hum Lact. 2008 Nov;24(4):386-92; quiz 451-3. doi: 10.1177/0890334408323545. Epub 2008 Sep 10. — View Citation

Taylor A, Atkins R, Kumar R, Adams D, Glover V. A new Mother-to-Infant Bonding Scale: links with early maternal mood. Arch Womens Ment Health. 2005 May;8(1):45-51. doi: 10.1007/s00737-005-0074-z. Epub 2005 May 4. — View Citation

Wu W, Zhang J, Silva Zolezzi I, Fries LR, Zhao A. Factors influencing breastfeeding practices in China: A meta-aggregation of qualitative studies. Matern Child Nutr. 2021 Oct;17(4):e13251. doi: 10.1111/mcn.13251. Epub 2021 Aug 6. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Breastfeeding Self-Efficacy Scale-short form The short version of the breastfeeding self-efficacy scale consisted of a total of 14 items evaluating breastfeeding self-efficacy. The scale is in a 5-point Likert type and is evaluated as 1 = I am not sure at all, 5 = I am always sure. The minimum score that can be obtained from the scale is 14, and the maximum is 70. 3 months
Primary Mother to Infant Bonding Scale Mother to Infant Bonding Scale is a measurement tool that can be applied from the first day after birth and allows the mother to express her feelings towards her baby in a single word.
The lowest total score that can be obtained from the scale is 0 and the highest score is 24.
3 months
Primary Father Breastfeeding Self-Efficacy Scale Short Form This scale is a 14-item questionnaire that assesses a father's confidence in his ability to assist his partner with breastfeeding. The scale is in a 5-point Likert type and is evaluated as 1 = I am not sure at all, 5 = I am always sure. The minimum score that can be obtained from the scale is 14, and the maximum is 70. 3 months
Primary Paternal -Infant Attachment Questionnaire The scale developed to evaluate postnatal father-infant attachment is a 19-item scale. Scale; It consists of three sub-dimensions: 'patience and tolerance', 'pleasure in interaction' and 'love and pride'. Each item of the scale is scored between 1 and 5 points. High scores indicate high attachment. 3 months
Primary Baby Evaluation Form The infant evaluation form was created by the researchers in line with the literature. In this form, there are questions about the height, weight and head circumference measurements of the babies, the way of feeding, whether they use pacifiers and bottles. 3 months
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