BreastfeedingNCT05433818
The Effect of Breastfeeding Education and Skin-to-Skin Contact on Breastfeeding Efficiency and Maternal Attachment
A study testing Group A and Group B in people with Breastfeeding and Postpartum, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The study aimed to compare the effects of breastfeeding education and skin-to-skin contact on breastfeeding efficiency and maternal attachment. Design: This study was planned as a three-group randomized controlled study. 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
- Breastfeeding, Postpartum, Infant Development
- What is being tested?
- Group A and Group B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 15 May 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
- were having a primiparous pregnancy,
- being open to cooperation,
- having a vaginal delivery,
- giving a single mature birth,
- having no communication problem
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Science University
Kütahya, 43000
About this study
Official title: The Effect of Breastfeeding Education and Skin-to-Skin Contact on Breastfeeding Efficiency and Maternal Attachment: A Randomized Controlled Study
Objective: The study aimed to compare the effects of breastfeeding education and skin-to-skin contact on breastfeeding efficiency and maternal attachment.
Design: This study was planned as a three-group randomized controlled study. Setting and participants: This study will conduct with 92 women in a delivery room in Turkey between October 2021 and May 2022.
Methods: The study consists of continuous early skin-to-skin contact (SSC; Group A), breastfeeding education (Group B), and control groups (Group C). Group A received SSC education and Group B received structured breastfeeding education.
Read the detailed description
Primiparous women in the latent phase will given detailed information about the study (purpose and benefits of the study) and the pregnant women will invited to the study. Pregnant women will assigned to one of three groups (1:1:1) as A, B, and C in the www.randomizer.org program. Prior to the interventions, the Mother-Infant Information Form and MAI will applied to the pregnant women. After the interventions, MAI and BBAT will applied at an appropriate time when the participants felt most comfortable and rested and their perceptions will clear (4-6 hours postpartum). Eventually, the study sample will composed of 93 pregnant women based on the CONSORT 2010 (http://www.consort-statement.org/) flow diagram: 31 participants in Group A, and 31 in the Groups B, C (Figure 1).
SSC (Group-A) Pregnant women will assigned to Group A will informed about SSC. SSC will ensured postpartum in a supported diagonal-flexion position continuously by the researchers for 45-120 minutes. Mothers in group A will also benefit from the hospital's routine breastfeeding education service.
Structured Breastfeeding Education Program (Group-B) Structured breastfeeding education material will prepared to increase breastfeeding awareness and level of knowledge. Opinions will received from 7 different experts for the education booklet and brochure. The material will revised based on expert opinions. A brochure and educational material will administered to 10 pregnant women before the study and the material will found to be understandable. The education booklet include breastfeeding techniques, the benefits of breast milk, the benefits of breastfeeding, solution suggestions for breastfeeding problems, lactation mechanism, and storage of breast milk. The breastfeeding brochure include educational texts, educators' contact information, and pictures.
Group B will receive face-to-face breastfeeding education in the first phase of labor. A copy of the brochure will given to the pregnant women. In the early postpartum period, breastfeeding will encouraged practically and observed by the researchers. Participants' questions will answered.
Control (Group-C) No intervention will made to Group C by the researchers. Participants benefite from the hospital's routine care and breastfeeding education services. Posttests will applied in a way that would not interrupt the routine care and education practices of the hospital.
- Conditions
- Breastfeeding, Postpartum, Infant Development
- Being tested
- Group A, Group B
- Keywords
- Breastfeeding education, Breastfeeding efficiency, Infant, Maternal attachment, Skin-to-skin contact
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ABehavioural
Also called Skin-to-skin Contact
Skin-to-Skin Contact (SSC) contributes to mother-infant interaction and can increase breastfeeding success
Group BOther
Also called Breastfeeding education
education with a structured and expert opinion-based breastfeeding brochure
| Study group | Role | What they receive |
|---|---|---|
| Skin-to-skin care | Experimental | Pregnant women will assigned to SSC were inform about SSC. SSC will ensured postpartum in a supported diagonal-flexion position continuously by the researchers for 45-120 minutes. Mothers in group A also benefit from the hospital's routine breastfeeding education service.
As a result, after the SSC application, the mother will be evaluated with the breastfeeding efficiency scale and the maternal attachment scale. Receives: Behavioral: Group A |
| Breastfeeding Education | Active comparator | Group B will received face-to-face breastfeeding education in the first phase of labor. A copy of the brochure will given to the pregnant women. In the early postpartum period, breastfeeding will encouraged practically and observed by the researchers. Participants' questions will answered. As a result, after the breastfeeding education, the mother will be evaluated with the breastfeeding efficiency scale and the maternal attachment scale. Receives: Other: Group B |
| Kontrol | No intervention | No intervention will made to Group C by the researchers. Participants will benefit from the hospital's routine care and breastfeeding education services. As a result, postpartum mother will be evaluated with breastfeeding efficiency scale and maternal attachment scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin-to-skin contact
Positive effect of skin-to-skin contact on maternal attachment and breastfeeding efficiency
Measured: 6-8 hours
Breastfeeding education
positive effect of providing education with a structured and expert opinion-based breastfeeding brochure on maternal attachment and breastfeeding efficiency
Measured: 6-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start15 Jan 2022
- Primary completion15 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433818
- Sponsor's protocol ID
- E-41997688-050.99-26938
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Education and Skin-to-Skin Contact on Breastfeeding Efficiency and Maternal Attachment: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05433818
- Acronym / sponsor ID
- E-41997688-050.99-26938
- Conditions
- Breastfeeding, Postpartum, Infant Development
- Keywords
- Breastfeeding education, Breastfeeding efficiency, Infant, Maternal attachment, Skin-to-skin contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 27 Jun 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.
Objective: The study aimed to compare the effects of breastfeeding education and skin-to-skin contact on breastfeeding efficiency and maternal attachment.
Design: This study was planned as a three-group randomized controlled study. Setting and participants: This study will conduct with 92 women in a delivery room in Turkey between October 2021 and May 2022.
Methods: The study consists of continuous early skin-to-skin contact (SSC; Group A), breastfeeding education (Group B), and control groups (Group C). Group A received SSC education and Group B received structured breastfeeding education.
Detailed description
Primiparous women in the latent phase will given detailed information about the study (purpose and benefits of the study) and the pregnant women will invited to the study. Pregnant women will assigned to one of three groups (1:1:1) as A, B, and C in the www.randomizer.org program. Prior to the interventions, the Mother-Infant Information Form and MAI will applied to the pregnant women. After the interventions, MAI and BBAT will applied at an appropriate time when the participants felt most comfortable and rested and their perceptions will clear (4-6 hours postpartum). Eventually, the study sample will composed of 93 pregnant women based on the CONSORT 2010 (http://www.consort-statement.org/) flow diagram: 31 participants in Group A, and 31 in the Groups B, C (Figure 1).
SSC (Group-A) Pregnant women will assigned to Group A will informed about SSC. SSC will ensured postpartum in a supported diagonal-flexion position continuously by the researchers for 45-120 minutes. Mothers in group A will also benefit from the hospital's routine breastfeeding education service.
Structured Breastfeeding Education Program (Group-B) Structured breastfeeding education material will prepared to increase breastfeeding awareness and level of knowledge. Opinions will received from 7 different experts for the education booklet and brochure. The material will revised based on expert opinions. A brochure and educational material will administered to 10 pregnant women before the study and the material will found to be understandable. The education booklet include breastfeeding techniques, the benefits of breast milk, the benefits of breastfeeding, solution suggestions for breastfeeding problems, lactation mechanism, and storage of breast milk. The breastfeeding brochure include educational texts, educators' contact information, and pictures.
Group B will receive face-to-face breastfeeding education in the first phase of labor. A copy of the brochure will given to the pregnant women. In the early postpartum period, breastfeeding will encouraged practically and observed by the researchers. Participants' questions will answered.
Control (Group-C) No intervention will made to Group C by the researchers. Participants benefite from the hospital's routine care and breastfeeding education services. Posttests will applied in a way that would not interrupt the routine care and education practices of the hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Skin-to-skin care | Experimental | Behavioral: Group APregnant women will assigned to SSC were inform about SSC. SSC will ensured postpartum in a supported diagonal-flexion position continuously by the researchers for 45-120 minutes. Mothers in group A also benefit from the hospital's routine breastfeeding education service. As a result, after the SSC application, the mother will be evaluated with the breastfeeding efficiency scale and the maternal attachment scale. |
| Breastfeeding Education | Active comparator | Other: Group BGroup B will received face-to-face breastfeeding education in the first phase of labor. A copy of the brochure will given to the pregnant women. In the early postpartum period, breastfeeding will encouraged practically and observed by the researchers. Participants' questions will answered. As a result, after the breastfeeding education, the mother will be evaluated with the breastfeeding efficiency scale and the maternal attachment scale. |
| Kontrol | No intervention | –No intervention will made to Group C by the researchers. Participants will benefit from the hospital's routine care and breastfeeding education services. As a result, postpartum mother will be evaluated with breastfeeding efficiency scale and maternal attachment scale. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- were having a primiparous pregnancy,
- being open to cooperation,
- having a vaginal delivery,
- giving a single mature birth,
- having no communication problem
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Group AAlso: Skin-to-skin ContactSkin-to-Skin Contact (SSC) contributes to mother-infant interaction and can increase breastfeeding success | Behavioural | Skin-to-skin care |
| Group BAlso: Breastfeeding educationeducation with a structured and expert opinion-based breastfeeding brochure | Other | Breastfeeding Education |
Primary outcome
Skin-to-skin contact
Time frame: 6-8 hours
Positive effect of skin-to-skin contact on maternal attachment and breastfeeding efficiency
Breastfeeding education
Time frame: 6-8 hours
positive effect of providing education with a structured and expert opinion-based breastfeeding brochure on maternal attachment and breastfeeding efficiency
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 16 Feb 2023.
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
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 Group A and Group B in people with Breastfeeding and Postpartum, run by Kutahya Health Sciences 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 0 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 16 Feb 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?
Skin-to-skin contact (time frame: 6-8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2023.