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AzTrials

Pregnancy RelatedNCT06121973

The Effects of Video-Assisted Breastfeeding Education

A study testing educational group in people with Pregnancy Related and Breastfeeding, run by Erzurum Technical University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study was conducted to determine the effects of online video-assisted breastfeeding education on breastfeeding self-efficacy in primiparous pregnant women. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
educational group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2022to 1 Jan 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 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Having a primiparous pregnancy
  • Pregnant woman in the second trimester
  • There is no risk during pregnancy
  • Pregnant woman's ability to read and write
  • Volunteering to participate in the study

Who cannot join

  • Having auditory problems
  • Having visual problems
  • Having psychological problems
  • Having cognitive problems
  • Wanting to leave work

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ayşe Metin

    Erzurum, 25050

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Video-Assisted Breastfeeding Education Given to Primiparous Pregnant Women on Breastfeeding Self-Efficacy: Randomised Control Study

The present study was conducted to determine the effects of online video-assisted breastfeeding education on breastfeeding self-efficacy in primiparous pregnant women.

Read the detailed description

This two-group parallel randomized controlled study was conducted with pregnant women admitted to the pregnancy follow-up outpatient clinics of a university hospital in northern Turkey. The study was completed with 80 pregnant women in their second trimester, 40 pregnant women each in the intervention and control groups. Pregnant women in the intervention group received online video-assisted education which demonstrated first meeting of the mother-baby and first breastfeeding in addition to receiving counselling on breastfeeding. Pregnant women in the control group did not receive any intervention other than routine care. Data were collected face-to-face with the breastfeeding self-efficacy scale at the beginning of the study and two weeks later. In data analysis, chi-square test was used for categorical variables, independent sample t-test was used for continuous variables and intergroup comparison, and paired sample t-test was used for intragroup comparison.

Being tested
educational group
Keywords
Pregnancy, Breastfeeding self-efficacy, Breastfeeding education, Video-assisted education
Medical subject headings
Breast Feeding

What participants receive

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

  • educational groupBehavioural

    Experimental group received online video-supported breastfeeding education in an online classroom for 6-8 people and individual counselling via phone and Whatsapp application when needed for 3 weeks.

Study groups in NCT06121973
Study groupRoleWhat they receive
control groupNo interventionPregnant women in the control group did not receive any intervention other than routine care.
Experimental groupExperimentalPregnant women in the intervention group received online video-assisted education which demonstrated first meeting of the mother-baby and first breastfeeding in addition to receiving counselling on breastfeeding.
Receives: Behavioral: educational group

What is being measured

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

  1. Prenatal Breastfeeding Self-Efficacy Scale (PBSES)

    The scale was developed by Wells et al. (2006) to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period.(27) Turkish validity and reliability of the scale was conducted by Aydın and Pasinlioğlu (2016). The scale consists of a total of 20 items. Each item of the scale is a 5-point Likert scale ranging between "1=Not at all sure - 5= Completely sure". Minimum 20 and maximum 100 points can be obtained from the scale. Higher score indicates breastfeeding self-efficacy perception. Cronbach's alpha value of the scale was reported to be 0.86.(28) Cronbach's alpha value was found to be 0.96 in this study.

    Measured: 5 Minutes

Timeline

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

  1. First posted8 Nov 2023
  2. Study start1 Jun 2022
  3. Primary completion1 Dec 2022
  4. Study completion1 Jan 2023

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06121973
Sponsor's protocol ID
7412169
Status last verified
Aug 2024
First submitted
27 Oct 2023
Last updated
19 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The datasets used and/or analyzed during the current study are not publicly available due to the sensitive nature of the interviews. If someone wants to request the data from this study, the corresponding author should be contacted.

Publications

  • Yuen M, Hall OJ, Masters GA, Nephew BC, Carr C, Leung K, Griffen A, McIntyre L, Byatt N, Moore Simas TA. The Effects of Breastfeeding on Maternal Mental Health: A Systematic Review. J Womens Health (Larchmt). 2022 Jun;31(6):787-807. doi: 10.1089/jwh.2021.0504. Epub 2022 Apr 18.

    PubMed 35442804

  • Piro SS, Ahmed HM. Impacts of antenatal nursing interventions on mothers' breastfeeding self-efficacy: an experimental study. BMC Pregnancy Childbirth. 2020 Jan 6;20(1):19. doi: 10.1186/s12884-019-2701-0.

    PubMed 31906881

  • Karacam Z, Kitis Y. What do midwives and nurses in Turkey know about nutrition in the first six months of life. Midwifery. 2005 Mar;21(1):61-70. doi: 10.1016/j.midw.2004.09.005.

    PubMed 15740817

  • Perez-Escamilla R, Tomori C, Hernandez-Cordero S, Baker P, Barros AJD, Begin F, Chapman DJ, Grummer-Strawn LM, McCoy D, Menon P, Ribeiro Neves PA, Piwoz E, Rollins N, Victora CG, Richter L; 2023 Lancet Breastfeeding Series Group. Breastfeeding: crucially important, but increasingly challenged in a market-driven world. Lancet. 2023 Feb 11;401(10375):472-485. doi: 10.1016/S0140-6736(22)01932-8. Epub 2023 Feb 7.

    PubMed 36764313

  • Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

    PubMed 26869575

  • Kartal T, Gursoy E. Sürdürülebilir Kalkınma Amaçlarında (2015-2030) Emzirmenin Önemi ve Türkiye'deki Mevcut Durum Işığında Hemşireye Düşen Görevler. Mersin Üniversitesi Tıp Fakültesi Lokman Hekim Tıp Tarihi ve Folklorik Tıp Dergisi. 2020;10(2):147-53. https://doi.org/10.31020/mutftd.676389

  • Meek JY, Noble L; Section on Breastfeeding. Policy Statement: Breastfeeding and the Use of Human Milk. Pediatrics. 2022 Jul 1;150(1):e2022057988. doi: 10.1542/peds.2022-057988.

    PubMed 35921640

  • Wu Q, Tang N, Wacharasin C. Factors influencing exclusive breastfeeding for 6 months postpartum: A systematic review. Int J Nurs Knowl. 2022 Oct;33(4):290-303. doi: 10.1111/2047-3095.12360. Epub 2022 Jan 28.

    PubMed 35088945

  • McGovern L, Geraghty A, McAuliffe F, O'Reilly S. An exploration of prenatal breastfeeding self-efficacy: a scoping review protocol. Open Res Eur. 2023 Jan 24;2:91. doi: 10.12688/openreseurope.14938.3. eCollection 2022.

    PubMed 37645344

  • Dennis CL. Theoretical underpinnings of breastfeeding confidence: a self-efficacy framework. J Hum Lact. 1999 Sep;15(3):195-201. doi: 10.1177/089033449901500303. No abstract available.

    PubMed 10578797

  • Ummah F, Rosida L. Breastfeeding Self Efficacy Among Pregnant Women. Jurnal EduHealth. 2022;13(01):336-42.

  • Ghasemi V, Simbar M, Banaei M, Saei Ghare Naz M, Jahani Z, Nazem H. The effect of interventions on breastfeeding self-efficacy by using Bandura's theory in Iranian mothers: a systematic review. International Journal of Pediatrics. 2019;7(8):9939-54. https://doi.org/10.22038/ijp.2019.40842.3446

  • Ozturk R, Ergun S, Ozyazicioglu N. Effect of antenatal educational intervention on maternal breastfeeding self-efficacy and breastfeeding success: a quasi-experimental study. Rev Esc Enferm USP. 2022 Apr 4;56:e20210428. doi: 10.1590/1980-220X-REEUSP-2021-0428. eCollection 2022.

    PubMed 35377385

  • Demirci J, Caplan E, Murray N, Cohen S. "I Just Want to Do Everything Right:" Primiparous Women's Accounts of Early Breastfeeding via an App-Based Diary. J Pediatr Health Care. 2018 Mar-Apr;32(2):163-172. doi: 10.1016/j.pedhc.2017.09.010. Epub 2017 Dec 21.

    PubMed 29276003

  • Chantry CJ, Dewey KG, Peerson JM, Wagner EA, Nommsen-Rivers LA. In-hospital formula use increases early breastfeeding cessation among first-time mothers intending to exclusively breastfeed. J Pediatr. 2014 Jun;164(6):1339-45.e5. doi: 10.1016/j.jpeds.2013.12.035. Epub 2014 Feb 14.

    PubMed 24529621

Questions about this trial

What is this clinical trial studying?

A study testing educational group in people with Pregnancy Related and Breastfeeding, run by Erzurum Technical 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Aug 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prenatal Breastfeeding Self-Efficacy Scale (PBSES) (time frame: 5 Minutes). 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 NCT06121973, which also lists 38 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 19 Aug 2024.

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