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Volunteering to Participate in the StudyNCT06443801

Efficacy Of Web-based Breastfeeding Education

A study testing THE GROUP THAT WILL TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY in people with Volunteering to Participate in the Study, run by Nurdan Demirci 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Breastfeeding is the safest and healthiest method of feeding an infant and positively affects the health of both the mother and the baby in the short and long term. Breastfeeding self-efficacy refers to the mother's perceived ability and self-confidence to breastfeed her baby. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Volunteering to Participate in the Study
What is being tested?
THE GROUP THAT WILL TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2024to 15 Sep 2024
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Volunteering to participate in the study.
  • Being primiparous at 24-36 weeks of pregnancy.
  • To be able to speak and speak Turkish.
  • To be at least a primary school graduate.
  • Having a computer or smartphone at home and being able to use it.
  • No risk in pregnancy.
  • The woman does not have any chronic disease.

Who cannot join

  • The emergence of a risky situation during pregnancy.
  • Premature birth of the woman participating in the study.
  • Carrying out a risky birth and hospitalization of the mother or baby due to it.
  • Termination of pregnancy prematurely for any reason (such as infant death)
  • The fact that the pregnant women in the experimental group did not complete the training modules before birth.
  • The fact that the women participating in the study did not respond to the directed scales and questionnaires.
  • The woman's desire to quit working without giving any reason.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: The Efficiency Of Web-Based Breastfeeding Education In Pregnancy According To The Theory Of Breastfeeding Self-Efficacy

Breastfeeding is the safest and healthiest method of feeding an infant and positively affects the health of both the mother and the baby in the short and long term.

Breastfeeding self-efficacy refers to the mother's perceived ability and self-confidence to breastfeed her baby.

Read more

Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors.

Today, web-based support programs are created thanks to advances in science and technology; It has advantages such as being cheap, easily accessible, not causing any harm when done under control, providing flexibility in the participant's use of time, and accessing the training content whenever needed. Due to the pandemic process, the investigators are in and with the effect of developing technology, training is provided for the needs of individuals by using many alternative education methods such as web-based education and distance education in the field of health, as in many areas. Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors.

The study is planned to be carried out between 01.01.2023 and 31.07.2024 in the Family Health Centers affiliated with the Taşköprü District Health Directorate of Kastamonu. The study universe consists of 24-36 weeks pregnant women who come to the Family Health Centers of the Taşköprü District Health Directorate. The sample of the study consisted of 90 primiparous pregnant women, 45 of whom were in the control and 45 in the experimental group, who met the inclusion criteria.

Data collection tools will be applied to women at pregnancy, postpartum 7th day, PP in the 3rd month, and PP in the 6th month.

Appropriate methods will be used in the evaluation of the data. The significance level will be determined as α=0.05.

Read the detailed description

Breastfeeding is the safest and healthiest method of feeding an infant and positively affects the health of both the mother and the baby in the short and long term. Breast milk not only meets the nutritional needs of the newborn, but also protects it from many diseases, makes a great contribution to its mental and physical development, and most importantly, it provides a unique bond between mother and baby.

According to TDHS 2018 data, the rate of exclusive breastfeeding for the first six months is 41%, and this rate decreases with age. The rate of breastfeeding for 0-1-month-old children is 59%, 2-3-month-olds 45%, and 4-5-month-olds 14%.

One of the most important factors affecting breastfeeding is the mother's perception of self-efficacy. Breastfeeding self-efficacy refers to the mother's perceived ability and self-confidence to breastfeed her baby. Perception of breastfeeding self-efficacy; It determines whether the mother will breastfeed or not, how much effort she will put into it, her thoughts on breastfeeding, and her ability to cope with the difficulties she will face during the breastfeeding process emotionally.

Considering the existence of real or potential problems with breastfeeding, breastfeeding counseling is required for every expectant mother. This counseling will ensure that expectant mothers will be prepared for all kinds of breastfeeding problems that they may experience in the postpartum period. Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors.

For successful initiation, maintenance and termination of breastfeeding, mothers should be provided with a balanced diet during pregnancy, necessary breast care, physical and mental health, and training on breastfeeding.

Today, web-based support programs created thanks to advances in science and technology; It has advantages such as being cheap, easily accessible, not causing any harm when done under control, providing flexibility in the participant's use of time, and accessing the training content whenever needed. Due to the pandemic process the investigators are in and with the effect of developing technology, trainings are provided for the needs of individuals by using many alternative education methods such as web-based education and distance education in the field of health, as in many areas. Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors.

Studies on this subject are generally studies that briefly mention breastfeeding under the title of baby care and are not long enough. For this reason, the investigators aim to provide maximum benefit by giving this training to expectant mothers who have never given birth before, that is, who will breastfeed their baby for the first time, by addressing the issue of breastfeeding only.

The study is planned to be carried out between 01.01.2023 and 31.07.2024 in the Family Health Centers affiliated to the Taşköprü District Health Directorate of Kastamonu. The universe of the study consists of 24-36 weeks pregnant women who come to the Family Health Centers of the Taşköprü District Health Directorate. The sample of the study consisted of 90 primiparous pregnant women, 45 of whom were in the control and 45 in the experimental group, who met the inclusion criteria.

The data of the study will be applied to both groups at the same time. No training will be given to the control group, and web-based breastfeeding training consisting of 4 modules will be given to the experimental group during their pregnancy. As data collection tools; Pregnant data collection form, Postpartum information form, IOWA infant feeding attitude scale, IMDAT scale, Edinburgh depression scale, Breastfeeding motivation scale, Insufficient milk perception scale, Breastfeeding self-efficacy scale and System usability scale will be used. Data collection tools will be applied to women at pregnancy, postpartum 7th day, PP 3rd month and PP 6th month.

Appropriate methods will be used in the evaluation of the data. The significance level will be determined as α=0.05.

Being tested
THE GROUP THAT WILL TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY

What participants receive

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

  • THE GROUP THAT WILL TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCYOther

    The data of the study will be applied to both groups at the same time. No training will be given to the control group, and web-based breastfeeding training consisting of 4 modules will be given to the experimental group during their pregnancy. As data collection tools; Pregnant data collection form, Postpartum information form, IOWA infant feeding attitude scale, IMDAT scale, Edinburgh depression scale, Breastfeeding motivation scale, Insufficient milk perception scale, Breastfeeding self-efficacy scale and System usability scale will be used. Data collection tools will be applied to women at pregnancy, postpartum 7th day, PP 3rd month and PP 6th month.

    Appropriate methods will be used in the evaluation of the data. The significance level will be determined as α=0.05.

    The sample of the study consisted of 90 primiparous pregnant women, 45 of whom were in the control and 45 in the experimental group, who met the inclusion criteria.

Study groups in NCT06443801
Study groupRoleWhat they receive
THE GROUP THAT WILL NOT TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCYNo interventionThis group will not take web-based education.
THE GROUP THAT WİLL TAKE WEB-BASED BREASTFEEDİNG EDUCATION İN PREGNANTExperimentalthis group will take web-based education.
Receives: Other: THE GROUP THAT WILL TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY

What is being measured

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

  1. Number of postpartum women

    In the study, R v3.6.1 program was used for Power analysis, alpha error was 5%, beta error was 20%, it was predicted that between the variables as a result of the study process, and a minimum of 90 (45 case groups, 50 control group)

    Measured: 6 month

Secondary outcomes (4)
  1. Evaluation of Infant Feeding Attitude

    The Infant Feeding Attitude Scale is used. It includes 17 items with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Eight statements indicate positive attitude toward breastfeeding and nine statements indicate positive attitude toward formula feeding. The statements indicating positive attitude to breastfeeding were reverse-scored before calculating the total scores of all items. An example for attitude is: "Formula-feeding is more convenient than breastfeeding", and "Breastfeeding increases mother-infant bonding". The total IIFAS score can range from 17 to 85 with higher scores reflecting more positive attitude towards breastfeeding. The total IIFAS is further classified as positive to breastfeeding (a score of 70-85), neutral (a score of 49-69) and positive to formula feeding

    Measured: Antenatal and postpartum 6th month

  2. Evaluation of Depression Level

    Edinburgh Postnatal/Postpartum Depression Scale is a self-assessment scale developed to determine the risk of depression in the postpartum period and to measure the level and severity of depression. The scale consists of 10 questions in total. Each question provides a four-point Likert-type measurement. Items in questions 3, 5, 6, 7, 8, 9 and 10 of the scale are scored as 3, 2, 1, 0 and indicate gradually decreasing severity. The items in questions 1, 2 and 4 are scored as 0, 1, 2, 3, indicating increasing severity. The total score of the scale is obtained by summing these items. The minimum total score is 0 and the maximum score is 30. The cut-off score of the scale has been reported as 12/13.

    Measured: Postpartum 7th day, 3rd month, and 6th month

  3. Evaluation of Perception of Insufficient Milk

    Perception of Insufficient Milk questionnaire is used. The questionnaire consisted of five sections: urine amount, breast condition, stool amount, weight and satisfaction. The characteristics of each section were evaluated on a scale of 0,1,2 points, and a full score of 10 was considered as the best breast milk intake and 7 and below as inadequate breast milk intake.

    Measured: Postpartum 7th day, 3rd month, and 6th month

  4. Evaluation of Breastfeeding Self-Efficacy

    The Breastfeeding Self-Efficacy Short Form is a 5-point Likert-type scale (1= "I am never sure" and 5 = "I am always sure"). The minimum score is 14 and the maximum score is 70. A higher score indicates higher breastfeeding self-efficacy.

    Measured: Postpartum 7th day, 3rd month, and 6th month

Timeline

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

  1. First posted5 Jun 2024
  2. Study start15 May 2024
  3. Primary completion10 Aug 2024 (estimated)
  4. Study completion15 Sep 2024 (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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06443801
Sponsor's protocol ID
Marmara U- elıfvlgl-001
Status last verified
May 2024
First submitted
2 Oct 2023
Last updated
5 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kleinpell R, Ely EW, Williams G, Liolios A, Ward N, Tisherman SA. Web-based resources for critical care education. Crit Care Med. 2011 Mar;39(3):541-53. doi: 10.1097/CCM.0b013e318206b5b5.

    PubMed 21169819
  • Maloney S, Haas R, Keating JL, Molloy E, Jolly B, Sims J, Morgan P, Haines T. Breakeven, cost benefit, cost effectiveness, and willingness to pay for web-based versus face-to-face education delivery for health professionals. J Med Internet Res. 2012 Apr 2;14(2):e47. doi: 10.2196/jmir.2040.

    PubMed 22469659
  • 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
  • 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. 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
  • Velioglu E, Demirci N. The effect of web-based breastfeeding education given to primiparous pregnant women: a randomised controlled study. Afr J Reprod Health. 2024 Dec 31;28(12):61-72. doi: 10.29063/ajrh2024/v28i12.7.

    PubMed 39764800

Questions about this trial

What is this clinical trial studying?

A study testing THE GROUP THAT WILL TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY in people with Volunteering to Participate in the Study, run by Nurdan Demirci 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 7 inclusion and 7 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 5 Jun 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?

Results are not available in the source record.

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?

Number of postpartum women (time frame: 6 month). 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 NCT06443801, which also lists 6 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 5 Jun 2024.

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