Birth, FirstNCT05262231
Online Education and Breastfeeding Motivation
A study testing Online Breastfeeding Education in people with Birth, First and Breast Feeding, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Breastfeeding is not just a physiological event. Psychological and emotional factors affect breastfeeding. Motivation is also among these factors. For this reason, it should be considered that there will be problems with breastfeeding in the postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, First, Breast Feeding, Motivation
- What is being tested?
- Online Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Nov 2022
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be between 18-49 years old,
- Having given birth for the first time,
- Being in the postpartum period between the 4th and 8th weeks and breastfeeding,
- Volunteering to participate in the research,
- Speak and understand Turkish.
Who cannot join
- not be between the ages of 18-49,
- Having more than one birth,
- not breastfeeding,
- Not being able to speak or understand Turkish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Online Breastfeeding Education on Breastfeeding Motivation
Introduction: Breastfeeding is not just a physiological event. Psychological and emotional factors affect breastfeeding. Motivation is also among these factors. For this reason, it should be considered that there will be problems with breastfeeding in the postpartum period. Since breastfeeding education can be a solution to these problems, it can increase the motivation of mothers for breastfeeding.
Purpose: To examine the effect of online breastfeeding education on breastfeeding motivation.
Methods: The type of the study was planned as a prospective, randomized controlled experimental study with pretest-posttest control group. The sample group of the research will be reached at Pamukkale University Obstetrics and Gynecology clinic and online via social media. The sample reached will be trained in the online environment. The research will be carried out between February 2022 and December 2022. A total of 50 people, 25 in the experimental group and 25 in the control group, will be included. Evaluation will be made with the Breastfeeding motivation scale (for primiparous mothers). Motivation scores will be compared before and after the training.
Read the detailed description
Breastfeeding protects children against diseases such as gastrointestinal, asthma, diabetes, otitis media, sudden infant death syndrome and obesity. At the same time, it supports the increase of children's IQ level and brain development. Among the benefits for women's health are its contribution to the involution process in the postpartum period, protection against postpartum depression, ovarian and breast cancer. The social impact of breastfeeding is that it provides economic benefits.Despite all the benefits of breastfeeding, breastfeeding rates are not sufficient. Globally, the rate of exclusive breastfeeding of children for the first six months is 41%, and the rate of breastfeeding with complementary foods for two years is 45%.
There are many factors that affect breastfeeding. These; social, environmental, cultural and personal factors. These factors can affect the motivation of women internally and externally.For this reason, internal and external motivations of women will be supported with breastfeeding education.
- Conditions
- Birth, First, Breast Feeding, Motivation
- Being tested
- Online Breastfeeding Education
- Keywords
- Breastfeeding motivation, Breastfeeding, Online education, Postpartum period
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Breastfeeding EducationBehavioural
Breastfeeding education will be announced with a poster on social media. At the same time, mothers will be informed about the training in the institution where the institution permission is obtained. Postpartum period 4-8. A single-blind randomization method will be used per week. Pre-test will be applied to the mothers in the experimental and control groups. After the pre-test, online breastfeeding training will be given to the experimental group. The training consists of a single session. It will take about 40-60 minutes. The content of the training includes the benefits of breastfeeding for the mother, baby and society, breast problems and solutions, causes and solutions of breast rejection, breastfeeding positions, etc. consists of topics. After the training experimental group, the post-test will be applied. At the same time, the post-test will be applied to the control group who did not receive the training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Study group intervention consists 1-session. A session takes approximately 1 hour. The pre-test will be applied just before the intervention. The final test will be administered immediately after the intervention. Receives: Behavioral: Online Breastfeeding Education |
| No Intervention | No intervention | No intervention is applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Motivation Scale (For Primiparous Mothers)
The breastfeeding motivation scale developed for primiparous women consists of 23 questions.Intrinsic motivation consists of five sub-factors: integrated regulation, identified regulation, introjected regulation, and extrinsic regulation.The scale, which is a four-point Likert type scale, is scored as 1 = I strongly disagree, 2 = I do not agree, 3 = I agree, 4 = I strongly agree. Total points are not taken from the scale. As the score obtained from the scale sub-dimension increases, the motivation representing that sub-dimension also increases.
Measured: Change in motivation after a one-session training of approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Feb 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Birth, FirstStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Özkan, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262231
- Sponsor's protocol ID
- E-60116787-020-137020
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cangol E, Sahin NH. The Effect of a Breastfeeding Motivation Program Maintained During Pregnancy on Supporting Breastfeeding: A Randomized Controlled Trial. Breastfeed Med. 2017 May;12:218-226. doi: 10.1089/bfm.2016.0190. Epub 2017 Mar 13.
PubMed 28287819Khasawneh W, Kheirallah K, Mazin M, Abdulnabi S. Knowledge, attitude, motivation and planning of breastfeeding: a cross-sectional study among Jordanian women. Int Breastfeed J. 2020 Jul 1;15(1):60. doi: 10.1186/s13006-020-00303-x.
PubMed 32611353Louis-Jacques AF, Stuebe AM. Enabling Breastfeeding to Support Lifelong Health for Mother and Child. Obstet Gynecol Clin North Am. 2020 Sep;47(3):363-381. doi: 10.1016/j.ogc.2020.04.001. Epub 2020 Jul 2.
PubMed 32762923Peven K, Purssell E, Taylor C, Bick D, Lopez VK. Breastfeeding support in low and middle-income countries: Secondary analysis of national survey data. Midwifery. 2020 Mar;82:102601. doi: 10.1016/j.midw.2019.102601. Epub 2019 Dec 10.
PubMed 31935650Yildirim Goksen DF, Ozkan S. The effect of online breastfeeding education on breastfeeding motivation: A randomized controlled study. J Pediatr Nurs. 2024 Mar-Apr;75:e42-e48. doi: 10.1016/j.pedn.2023.12.026. Epub 2024 Jan 5.
PubMed 38182483
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Online Breastfeeding Education on Breastfeeding Motivation
- ClinicalTrials.gov ID
- NCT05262231
- Acronym / sponsor ID
- E-60116787-020-137020
- Conditions
- Birth, First, Breast Feeding, Motivation
- Keywords
- Breastfeeding motivation, Breastfeeding, Online education, Postpartum period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Breastfeeding is not just a physiological event. Psychological and emotional factors affect breastfeeding. Motivation is also among these factors. For this reason, it should be considered that there will be problems with breastfeeding in the postpartum period. Since breastfeeding education can be a solution to these problems, it can increase the motivation of mothers for breastfeeding.
Purpose: To examine the effect of online breastfeeding education on breastfeeding motivation.
Methods: The type of the study was planned as a prospective, randomized controlled experimental study with pretest-posttest control group. The sample group of the research will be reached at Pamukkale University Obstetrics and Gynecology clinic and online via social media. The sample reached will be trained in the online environment. The research will be carried out between February 2022 and December 2022. A total of 50 people, 25 in the experimental group and 25 in the control group, will be included. Evaluation will be made with the Breastfeeding motivation scale (for primiparous mothers). Motivation scores will be compared before and after the training.
Detailed description
Breastfeeding protects children against diseases such as gastrointestinal, asthma, diabetes, otitis media, sudden infant death syndrome and obesity. At the same time, it supports the increase of children's IQ level and brain development. Among the benefits for women's health are its contribution to the involution process in the postpartum period, protection against postpartum depression, ovarian and breast cancer. The social impact of breastfeeding is that it provides economic benefits.Despite all the benefits of breastfeeding, breastfeeding rates are not sufficient. Globally, the rate of exclusive breastfeeding of children for the first six months is 41%, and the rate of breastfeeding with complementary foods for two years is 45%.
There are many factors that affect breastfeeding. These; social, environmental, cultural and personal factors. These factors can affect the motivation of women internally and externally.For this reason, internal and external motivations of women will be supported with breastfeeding education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Online Breastfeeding EducationStudy group intervention consists 1-session. A session takes approximately 1 hour. The pre-test will be applied just before the intervention. The final test will be administered immediately after the intervention. |
| No Intervention | No intervention | –No intervention is applied to the control group. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be between 18-49 years old,
- Having given birth for the first time,
- Being in the postpartum period between the 4th and 8th weeks and breastfeeding,
- Volunteering to participate in the research,
- Speak and understand Turkish.
Key exclusion criteria (4 listed)
- not be between the ages of 18-49,
- Having more than one birth,
- not breastfeeding,
- Not being able to speak or understand Turkish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Breastfeeding EducationBreastfeeding education will be announced with a poster on social media. At the same time, mothers will be informed about the training in the institution where the institution permission is obtained. Postpartum period 4-8. A single-blind randomization method will be used per week. Pre-test will be applied to the mothers in the experimental and control groups. After the pre-test, online breastfeeding training will be given to the experimental group. The training consists of a single session. It will take about 40-60 minutes. The content of the training includes the benefits of breastfeeding for the mother, baby and society, breast problems and solutions, causes and solutions of breast rejection, breastfeeding positions, etc. consists of topics. After the training experimental group, the post-test will be applied. At the same time, the post-test will be applied to the control group who did not receive the training. | Behavioural | Experimental |
Primary outcome
Breastfeeding Motivation Scale (For Primiparous Mothers)
Time frame: Change in motivation after a one-session training of approximately 1 hour
The breastfeeding motivation scale developed for primiparous women consists of 23 questions.Intrinsic motivation consists of five sub-factors: integrated regulation, identified regulation, introjected regulation, and extrinsic regulation.The scale, which is a four-point Likert type scale, is scored as 1 = I strongly disagree, 2 = I do not agree, 3 = I agree, 4 = I strongly agree. Total points are not taken from the scale. As the score obtained from the scale sub-dimension increases, the motivation representing that sub-dimension also increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Results publication: PubMed 28287819Cangol E, Sahin NH. The Effect of a Breastfeeding Motivation Program Maintained During Pregnancy on Supporting Breastfeeding: A Randomized Controlled Trial. Breastfeed Med. 2017 May;12:218-226. doi: 10.1089/bfm.2016.0190. Epub 2017 Mar 13.
- Results publication: PubMed 32611353Khasawneh W, Kheirallah K, Mazin M, Abdulnabi S. Knowledge, attitude, motivation and planning of breastfeeding: a cross-sectional study among Jordanian women. Int Breastfeed J. 2020 Jul 1;15(1):60. doi: 10.1186/s13006-020-00303-x.
- Results publication: PubMed 32762923Louis-Jacques AF, Stuebe AM. Enabling Breastfeeding to Support Lifelong Health for Mother and Child. Obstet Gynecol Clin North Am. 2020 Sep;47(3):363-381. doi: 10.1016/j.ogc.2020.04.001. Epub 2020 Jul 2.
- Results publication: PubMed 31935650Peven K, Purssell E, Taylor C, Bick D, Lopez VK. Breastfeeding support in low and middle-income countries: Secondary analysis of national survey data. Midwifery. 2020 Mar;82:102601. doi: 10.1016/j.midw.2019.102601. Epub 2019 Dec 10.
- Derived from this study: PubMed 38182483Yildirim Goksen DF, Ozkan S. The effect of online breastfeeding education on breastfeeding motivation: A randomized controlled study. J Pediatr Nurs. 2024 Mar-Apr;75:e42-e48. doi: 10.1016/j.pedn.2023.12.026. Epub 2024 Jan 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Breastfeeding Education in people with Birth, First and Breast Feeding, run by Pamukkale 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 4 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 5 Apr 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?
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?
Breastfeeding Motivation Scale (For Primiparous Mothers) (time frame: Change in motivation after a one-session training of approximately 1 hour). 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 NCT05262231, which also lists 5 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 Apr 2023.