BreastfeedingNCT06119828
The Effect of Breastfeeding Education Given to Family Members on Breastfeeding Parameters
A study testing breastfeeding education for family members and receiving routine breastfeeding training in people with Breastfeeding, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Breastfeeding Education Given to Family Members Who Support the Mother in the Postpartum Period on Breastfeeding Parameters. Istanbul University-Cerrahpaşa Graduate Education Institute, Midwifery Department. Doctoral Thesis. Istanbul. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- breastfeeding education for family members and receiving routine breastfeeding training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Apr 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For mothers;
- Will receive support from a family member during the postpartum period,
- Having an uncomplicated pregnancy and birth history,
- No multiple pregnancy,
- Not giving birth before the 37th week of pregnancy,
- Not having any disease that prevents breastfeeding in the postpartum period (undergoing chemotherapy, active tuberculosis, using drugs that prevent breastfeeding, etc.),
Show all 14Show fewer
- Spending the pregnancy period and the first month after birth in the area where the research will be conducted,
- Being at least a primary school graduate,
- No communication problems,
- Being primiparous or multiparous with breastfeeding problems,
- For the family member who will provide support to the mother in the postpartum period, as long as the baby does not have any health problems that prevent breastfeeding;
- Spending time with the mother regularly for at least 1 hour at least five days a week during the postpartum period,
- Being able to communicate in Turkish,
- It was defined as residing in the same city during the period when the research data was collected.
Who cannot join
- For mothers;
- Those with a history of complicated pregnancy and birth,
- Those with multiple pregnancies,
- Those with premature babies,
- Conditions related to mother and baby that prevent breastfeeding in the postpartum period (pregnancy psychosis, congenital anomaly, sucking and swallowing coordination disorder, etc.),
- Those who will not live in the area where the research will be conducted during pregnancy and the first month after birth,
- Those who have difficulty communicating for various reasons (not being able to speak Turkish, serious hearing problems, etc.)
- Mothers who did not meet the research criteria for any reason after being included in the study (interventional birth, the baby having any disease requiring hospitalization in neonatal intensive care, etc.) were excluded from the scope of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF BREASTFEEDING EDUCATıON ON BREASTFEEDING PARAMETERS GIVEN TO FAMILY MEMBERS PROVIDING SUPPORT TO THE MOTHER IN THE POSTPARTUM PERİOD
The Effect of Breastfeeding Education Given to Family Members Who Support the Mother in the Postpartum Period on Breastfeeding Parameters. Istanbul University-Cerrahpaşa Graduate Education Institute, Midwifery Department. Doctoral Thesis. Istanbul.
I To examine the effect of breastfeeding education given to family members in the postpartum period on breastfeeding parameters. It was conducted as a randomized controlled experimental study to determine the effect of breastfeeding education given to the family member who supports the mother in the postpartum period on breastfeeding parameters
Read the detailed description
Power analysis was performed using the G*Power(v3.1.9) program to determine the sample size. The power of the study is expressed as 1-β (β = probability of type II error) and in general, studies must have 80% power. According to the effect size coefficients determined by Cohen, assuming that the evaluations to be made between two independent groups will have a medium effect size (d = 0.5), α = 0.05 and β = 0.20, it was determined that there should be at least 64 people in each group, according to the calculation. Considering that there may be losses during the study process, the sample size was increased by 20% and it was decided to include at least 77 people in each group. The calculation of the sample size was based on Zeliha Burcu Baysal's doctoral thesis titled The Effect of Breastfeeding Education and Counseling Given to Pregnant Women and Their Spouses on the Breastfeeding Process and Attachment.
The main aims of the study are:
Breastfeeding education given to the family member; Does it increase the rate of mothers starting breastfeeding? Breastfeeding education given to the family member; Does it increase the rate of mothers giving exclusive breastfeeding in the first month? In the intervention group, family members will be given breastfeeding education and they will be asked to support mothers in the postpartum period.
In the comparison group, no breastfeeding education was given to the family member.
- Conditions
- Breastfeeding
- Being tested
- breastfeeding education for family members, receiving routine breastfeeding training
- Keywords
- family member, breastfeeding self-efficacy, nutritional attitude
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeeding education for family membersBehavioural
Also called education
The first breastfeeding skills of mothers who gave birth in the delivery room and the first breastfeeding skills after birth were evaluated using BEDÖ. After giving birth, mothers were taken to the maternity ward after being kept under control in the delivery room for 2 hours. After the mothers' 1-hour breastfeeding was evaluated in the delivery room, the training phase of family members began. CBT was administered to family members in the waiting room before the training, which lasted approximately 7-8 minutes. Then, breastfeeding training was given to family members for 20-25 minutes. BBST was applied after the mother transferred to the maternity ward. Before the mother and the baby were discharged from the hospital, BEDÖ and BBTÖ were administered to the family member. On the 15th postpartum day, the family member was called by phone and reminded about breastfeeding education. At the first month postpartum,Checklist were administered to the mother via telephone conversation
receiving routine breastfeeding trainingOther
Also called Control groups
After giving birth, mothers were taken to the maternity ward after being kept under control in the delivery room for 2 hours. Mothers' breastfeeding was evaluated at the 1st hour in the delivery room. CBT was administered to family members in the waiting room. BBST was applied after the mother transferred to the maternity ward. Before the mother and the baby were discharged from the hospital, BEDÖ and BBTÖ were administered to the family member. At the first month postpartum, BBTÖ was administered to the family member, and BBTÖ and EÖY scale and Breastfeeding Checklist were administered to the mother over the phone.
| Study group | Role | What they receive |
|---|---|---|
| Parallel Asignment | Experimental | Power analysis was performed using the G*Power(v3.1.9) program to determine the sample size. The power of the study is expressed as 1-β (β = probability of type II error) and in general, studies must have 80% power. According to the effect size coefficients determined by Cohen, assuming that the evaluations to be made between two independent groups will have a medium effect size (d = 0.5), α = 0.05 and β = 0.20, it was determined that there should be at least 64 people in each group, according to the calculation. Receives: Behavioral: breastfeeding education for family members; Other: receiving routine breastfeeding training |
What is being measured
The primary outcome is the main question the study is designed to answer.
breastfeeding education given to family members
Breastfeeding education given to the family member; Does it increase the rate of mothers starting breastfeeding? Breastfeeding education given to the family member; Does it increase the rate of mothers giving exclusive breastfeeding in the first month?
Measured: postpartum 1st month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Not applicable
- Intervention model
- Sequential
- Model description
- It was conducted as a randomized controlled experimental study to determine the effect of breastfeeding education given to the family member who supports the mother in the postpartum period on breastfeeding parameters.
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cevriye Ocaktan Tetikçok, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119828
- Sponsor's protocol ID
- 2019/706
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans for use by other workers.
Publications
Holbrook KE, White MC, Heyman MB, Wojcicki JM. Maternal sociodemographic characteristics and the use of the Iowa Infant Attitude Feeding Scale to describe breastfeeding initiation and duration in a population of urban, Latina mothers: a prospective cohort study. Int Breastfeed J. 2013 Jul 8;8(1):7. doi: 10.1186/1746-4358-8-7.
PubMed 23835065Han FL, Ho YJ, McGrath JM. The influence of breastfeeding attitudes on breastfeeding behavior of postpartum women and their spouses. Heliyon. 2023 Feb 23;9(3):e13987. doi: 10.1016/j.heliyon.2023.e13987. eCollection 2023 Mar.
PubMed 36879970Houghtaling B, Byker Shanks C, Ahmed S, Rink E. Grandmother and health care professional breastfeeding perspectives provide opportunities for health promotion in an American Indian community. Soc Sci Med. 2018 Jul;208:80-88. doi: 10.1016/j.socscimed.2018.05.017. Epub 2018 May 8.
PubMed 29772397
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF BREASTFEEDING EDUCATıON ON BREASTFEEDING PARAMETERS GIVEN TO FAMILY MEMBERS PROVIDING SUPPORT TO THE MOTHER IN THE POSTPARTUM PERİOD
- ClinicalTrials.gov ID
- NCT06119828
- Acronym / sponsor ID
- 2019/706
- Conditions
- Breastfeeding
- Keywords
- family member, breastfeeding self-efficacy, nutritional attitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 7 Nov 2023 (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.
The Effect of Breastfeeding Education Given to Family Members Who Support the Mother in the Postpartum Period on Breastfeeding Parameters. Istanbul University-Cerrahpaşa Graduate Education Institute, Midwifery Department. Doctoral Thesis. Istanbul.
I To examine the effect of breastfeeding education given to family members in the postpartum period on breastfeeding parameters. It was conducted as a randomized controlled experimental study to determine the effect of breastfeeding education given to the family member who supports the mother in the postpartum period on breastfeeding parameters
Detailed description
Power analysis was performed using the G*Power(v3.1.9) program to determine the sample size. The power of the study is expressed as 1-β (β = probability of type II error) and in general, studies must have 80% power. According to the effect size coefficients determined by Cohen, assuming that the evaluations to be made between two independent groups will have a medium effect size (d = 0.5), α = 0.05 and β = 0.20, it was determined that there should be at least 64 people in each group, according to the calculation. Considering that there may be losses during the study process, the sample size was increased by 20% and it was decided to include at least 77 people in each group. The calculation of the sample size was based on Zeliha Burcu Baysal's doctoral thesis titled The Effect of Breastfeeding Education and Counseling Given to Pregnant Women and Their Spouses on the Breastfeeding Process and Attachment.
The main aims of the study are:
Breastfeeding education given to the family member; Does it increase the rate of mothers starting breastfeeding? Breastfeeding education given to the family member; Does it increase the rate of mothers giving exclusive breastfeeding in the first month? In the intervention group, family members will be given breastfeeding education and they will be asked to support mothers in the postpartum period.
In the comparison group, no breastfeeding education was given to the family member.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It was conducted as a randomized controlled experimental study to determine the effect of breastfeeding education given to the family member who supports the mother in the postpartum period on breastfeeding parameters.
| Arm | Type | Receives |
|---|---|---|
| Parallel Asignment | Experimental | Behavioral: breastfeeding education for family members, Other: receiving routine breastfeeding trainingPower analysis was performed using the G*Power(v3.1.9) program to determine the sample size. The power of the study is expressed as 1-β (β = probability of type II error) and in general, studies must have 80% power. According to the effect size coefficients determined by Cohen, assuming that the evaluations to be made between two independent groups will have a medium effect size (d = 0.5), α = 0.05 and β = 0.20, it was determined that there should be at least 64 people in each group, according to the calculation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- For mothers;
- Will receive support from a family member during the postpartum period,
- Having an uncomplicated pregnancy and birth history,
- No multiple pregnancy,
- Not giving birth before the 37th week of pregnancy,
Key exclusion criteria (8 listed)
- For mothers;
- Those with a history of complicated pregnancy and birth,
- Those with multiple pregnancies,
- Those with premature babies,
- Conditions related to mother and baby that prevent breastfeeding in the postpartum period (pregnancy psychosis, congenital anomaly, sucking and swallowing coordination disorder, etc.),
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 |
|---|---|---|
| breastfeeding education for family membersAlso: educationThe first breastfeeding skills of mothers who gave birth in the delivery room and the first breastfeeding skills after birth were evaluated using BEDÖ. After giving birth, mothers were taken to the maternity ward after being kept under control in the delivery room for 2 hours. After the mothers' 1-hour breastfeeding was evaluated in the delivery room, the training phase of family members began. CBT was administered to family members in the waiting room before the training, which lasted approximately 7-8 minutes. Then, breastfeeding training was given to family members for 20-25 minutes. BBST was applied after the mother transferred to the maternity ward. Before the mother and the baby were discharged from the hospital, BEDÖ and BBTÖ were administered to the family member. On the 15th postpartum day, the family member was called by phone and reminded about breastfeeding education. At the first month postpartum,Checklist were administered to the mother via telephone conversation | Behavioural | Parallel Asignment |
| receiving routine breastfeeding trainingAlso: Control groupsAfter giving birth, mothers were taken to the maternity ward after being kept under control in the delivery room for 2 hours. Mothers' breastfeeding was evaluated at the 1st hour in the delivery room. CBT was administered to family members in the waiting room. BBST was applied after the mother transferred to the maternity ward. Before the mother and the baby were discharged from the hospital, BEDÖ and BBTÖ were administered to the family member. At the first month postpartum, BBTÖ was administered to the family member, and BBTÖ and EÖY scale and Breastfeeding Checklist were administered to the mother over the phone. | Other | Parallel Asignment |
Primary outcome
breastfeeding education given to family members
Time frame: postpartum 1st month
Breastfeeding education given to the family member; Does it increase the rate of mothers starting breastfeeding? Breastfeeding education given to the family member; Does it increase the rate of mothers giving exclusive breastfeeding in the first month?
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 7 Nov 2023.
- Results publication: PubMed 23835065Holbrook KE, White MC, Heyman MB, Wojcicki JM. Maternal sociodemographic characteristics and the use of the Iowa Infant Attitude Feeding Scale to describe breastfeeding initiation and duration in a population of urban, Latina mothers: a prospective cohort study. Int Breastfeed J. 2013 Jul 8;8(1):7. doi: 10.1186/1746-4358-8-7.
- Results publication: PubMed 36879970Han FL, Ho YJ, McGrath JM. The influence of breastfeeding attitudes on breastfeeding behavior of postpartum women and their spouses. Heliyon. 2023 Feb 23;9(3):e13987. doi: 10.1016/j.heliyon.2023.e13987. eCollection 2023 Mar.
- Results publication: PubMed 29772397Houghtaling B, Byker Shanks C, Ahmed S, Rink E. Grandmother and health care professional breastfeeding perspectives provide opportunities for health promotion in an American Indian community. Soc Sci Med. 2018 Jul;208:80-88. doi: 10.1016/j.socscimed.2018.05.017. Epub 2018 May 8.
- Individual participant dataSharing planned: No. There are no plans for use by other workers.
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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 breastfeeding education for family members and receiving routine breastfeeding training in people with Breastfeeding, run by Selcuk 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 14 inclusion and 8 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 7 Nov 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 education given to family members (time frame: postpartum 1st 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 NCT06119828, which also lists 3 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 7 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.