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Breast FeedingNCT05921669

The Effect Of Traınıng On Breastfeedıng Gıven To Fathers On Breastfeedıng, Parent-Baby Bondıng And Breastfeedıng Self-Effıcacy Level

A study testing Provide breastfeeding education in people with Breast Feeding, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Breast Feeding
What is being tested?
Provide breastfeeding education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2023to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

İlfan Karanfil contact

05399819464

ilfan.koksal@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting

  • Eskişehir Osmangazi Üniversitesi Sağlık Bilimleri Fakültesi

    Eskişehir

    İlfan Karanfil, 05399819464, ilfan.koksal@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Conditions
Breast Feeding
Being tested
Provide breastfeeding education
Keywords
breastfeeding, paternal support, child health
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Provide breastfeeding educationBehavioural

    Providing breastfeeding education within the first 24 hours after birth

Study groups in NCT05921669
Study groupRoleWhat they receive
Experimental Group 1: The group in which breastfeeding training was given to mothers and fathersExperimentalFace-to-face theoretical breastfeeding training and then practical training (breastfeeding techniques, burping, changing diapers, milking by hand or pump, etc.) will be given by the researcher to the mothers and fathers. This training is planned to take 30-45 minutes. Then, an additional 15-30 minutes of father-supported breastfeeding training will be given to fathers. At the end of the training, the "Breastfeeding Booklet" prepared by the researchers will be given to the parents.
Receives: Behavioral: Provide breastfeeding education
Experimental Group 2: The group in which breastfeeding training was given only to the motherExperimentalOnly mothers will receive face-to-face theoretical breastfeeding training followed by practical training (breastfeeding techniques, flatulence, changing diapers, milking by hand or pump, etc.). This training is planned to take 30-45 minutes. At the end of the training, mothers will be given a "Breastfeeding Booklet" prepared by the researchers.
Receives: Behavioral: Provide breastfeeding education
Control Group: No intervention was made, group receiving routine hospital care)No interventionNo additional training will be given to this group by the researcher, apart from the trainings included in the routine procedures of the hospital.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. Paternal -İnfant 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.

    Measured: 3 months

  5. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start1 Apr 2023
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion1 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Before starting the research, parents will be informed about the study and written consent will be obtained from those who agree to participate in the research. There are 3 groups in the study. These; Experimental Group 1: The group in which breastfeeding training was given to mothers and fathers Experimental Group 2: The group in which breastfeeding training was given only to the mother Control Group: The group that did not receive any intervention and received routine hospital care. Within the first 24 hours after birth, everyone participating in the research will be contacted and the relevant forms will be filled in and breastfeeding training will be given to experimental group 1 and experimental group 2 by the researcher. Then, families will be called in the 1st week, 1st month and 3rd month by phone and the relevant forms will be filled. Families' questions about breastfeeding will be answered.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05921669
Sponsor's protocol ID
EskisehirOU-IKARANFIL-001-001
Status last verified
Jun 2023
First submitted
26 Mar 2023
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27870751

  • 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.

    PubMed 25452653

  • 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.

    PubMed 28448858

  • 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.

    PubMed 27450588

  • 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.

    PubMed 31711461

  • 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.

    PubMed 24720518

  • 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.

    PubMed 14649593

  • 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.

    PubMed 10520192

  • 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.

    PubMed 29864577

  • 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.

    PubMed 15571885

  • 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.

    PubMed 8176525

  • 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.

    PubMed 36323075

  • 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.

    PubMed 23603573

  • 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.

    PubMed 31936302

  • 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.

    PubMed 25129001

Questions about this trial

What is this clinical trial studying?

A study testing Provide breastfeeding education in people with Breast Feeding, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact İlfan Karanfil (05399819464, ilfan.koksal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breastfeeding Self-Efficacy Scale-short form (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05921669, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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