PostpartumNCT05663567
TheEffect of a Solution-FocusedApproach on Breastfeeding
A study testing solution oriented approach in people with Postpartum and Breastfeeding, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of a Solution-FocusedApproach on Breastfeeding Self-efficacy: A RandomizedControlledStudy It is a single-blind, randomized controlled study with a pre-test post-test design. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Breastfeeding, Self Efficacy
- What is being tested?
- solution oriented approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2024to 30 Apr 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Over 18 years old, literate,
- Can speak Turkish,
- Primiparous and at term and healthy delivery (38-42 weeks, 2500-4000g born, 5th minute APGAR score of 7 and above, no known congenital disease),
- Women who do not have a chronic disease that prevents breastfeeding in their baby or in themselves
- Does not have a systemic disease,
- Those who have never received a planned breastfeeding training before,
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- Having a healthy pregnancy,
- Planning to breastfeed,
- Women who have internet access, devices with internet usage (smartphone, computer, tablet, etc.), who have Zoom and Google Meet video conferencing applications on these devices.
- Women who can be reached within one week at the latest after giving birth
Who cannot join
- Women who do not want to breastfeed
- Women who have a disability to breastfeed
- Expressing that they cannot continue to work until the end,
- Women who did not participate and did not answer the post-test of the questionnaires.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eskisehir Osmnagazi Universty
Eskişehir, Eskişehir, 26480
ESRA NUR KABAKCI, 02222393750 ext. 1549, esranurkabakci@gmail.com
OZLEM CAGAN, PHD
About this study
Official title: TheEffect of a Solution-FocusedApproach on Breastfeeding Self-efficacy: A RandomizedControlledStudy
The Effect of a Solution-FocusedApproach on Breastfeeding Self-efficacy:
A RandomizedControlledStudy It is a single-blind, randomized controlled study with a pre-test post-test design.
In this study, it is aimed to increase the psychosocial health levels of mothers in the postpartum period and to eliminate their concerns about breastfeeding and infant feeding, with a solution-oriented approach planned to be applied to mothers with low breastfeeding self-efficacy. In addition, it is thought that the results of the research will make an important contribution to the national literature.
Question 1: Is a solution-oriented approach effective in increasing mothers' breastfeeding self-efficacy?
Read the detailed description
Solution-Focused Approach (COS) is a therapeutic counseling method developed by Steve de Shazer and Insoo Kim Berg et al. in the mid-1970s. This postmodern approach method focuses on the solution itself rather than going to the root of the problems, revealing the individual's past achievements and positive experiences. aims to remove.
One of the most important advantages of the Solution-Oriented Approach is that it is effective in a short time. Studies have shown that CFS can achieve the desired results between 6 and 10 sessions. It is important that the sessions and techniques of the Solution-Oriented Approach are used in harmony and that the sessions are structured. Particular attention is paid to the first session as it initiates the change and contributes to the process. In Solution-Oriented Approach, sessions are conducted as "first session" and "second and other sessions".
In this study, it is aimed to increase the psychosocial health levels of mothers in the postpartum period and to eliminate their concerns about breastfeeding and infant feeding, with a solution-oriented approach planned to be applied to mothers with low breastfeeding self-efficacy. In addition, it is thought that the results of the research will make an important contribution to the national literature
- Conditions
- Postpartum, Breastfeeding, Self Efficacy
- Being tested
- solution oriented approach
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solution oriented approachBehavioural
Implementing a solution-focused approach to support breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| experimental group 1 | Experimental | Implementing a solution-focused approach to support breastfeeding ONE TO ONE STUDY Receives: Behavioral: solution oriented approach |
| experimental group 2 | Experimental | Implementing a solution-focused approach to support breastfeeding GROUP STUDY Receives: Behavioral: solution oriented approach |
| No Intervention | No intervention | ROUTINE MAINTENANCE WILL BE DONE SOLUTION-FOCUSED APPROACH WILL NOT BE APPLIED. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing mothers' "breastfeeding self-efficacy scale score"
increase in breastfeeding success of lactating puerperant women (After the solution-oriented approach application, the breastfeeding self-efficacy scale The Breastfeeding Self-Efficacy Short Form Scale is a 5-point Likert-Type scale with 1= "I am not sure at all" and 5 = "I am always sure". As Bandura (1998) suggested, all items are positive. The minimum score that can be obtained from the scale is 14, and the maximum is 70.
Measured: 12 weeks
Increasing "Latch breastfeeding scale score"
After the solution-oriented approach application, the latch breastfeeding scale will be evaluated. Each item is evaluated between 0-2 points. The total score that can be taken from the scale is 10. The measurement tool has no cut-off point and the higher the LATCH score, the higher the success of breastfeeding.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start30 Jan 2024
- Primary completion26 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA NUR KABAKCI, Eskisehir Osmangazi University
- Investigators
- özlem CAGAN, PHD, Principal investigator, ocagan@ogu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663567
- Sponsor's protocol ID
- SFAB
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the research results are analyzed and published, access can be made.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TheEffect of a Solution-FocusedApproach on Breastfeeding Self-efficacy: A RandomizedControlledStudy
- ClinicalTrials.gov ID
- NCT05663567
- Acronym / sponsor ID
- SFAB
- Conditions
- Postpartum, Breastfeeding, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 26 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 23 Dec 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.
The Effect of a Solution-FocusedApproach on Breastfeeding Self-efficacy:
A RandomizedControlledStudy It is a single-blind, randomized controlled study with a pre-test post-test design.
In this study, it is aimed to increase the psychosocial health levels of mothers in the postpartum period and to eliminate their concerns about breastfeeding and infant feeding, with a solution-oriented approach planned to be applied to mothers with low breastfeeding self-efficacy. In addition, it is thought that the results of the research will make an important contribution to the national literature.
Question 1: Is a solution-oriented approach effective in increasing mothers' breastfeeding self-efficacy?
Detailed description
Solution-Focused Approach (COS) is a therapeutic counseling method developed by Steve de Shazer and Insoo Kim Berg et al. in the mid-1970s. This postmodern approach method focuses on the solution itself rather than going to the root of the problems, revealing the individual's past achievements and positive experiences. aims to remove.
One of the most important advantages of the Solution-Oriented Approach is that it is effective in a short time. Studies have shown that CFS can achieve the desired results between 6 and 10 sessions. It is important that the sessions and techniques of the Solution-Oriented Approach are used in harmony and that the sessions are structured. Particular attention is paid to the first session as it initiates the change and contributes to the process. In Solution-Oriented Approach, sessions are conducted as "first session" and "second and other sessions".
In this study, it is aimed to increase the psychosocial health levels of mothers in the postpartum period and to eliminate their concerns about breastfeeding and infant feeding, with a solution-oriented approach planned to be applied to mothers with low breastfeeding self-efficacy. In addition, it is thought that the results of the research will make an important contribution to the national literature
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental group 1 | Experimental | Behavioral: solution oriented approachImplementing a solution-focused approach to support breastfeeding ONE TO ONE STUDY |
| experimental group 2 | Experimental | Behavioral: solution oriented approachImplementing a solution-focused approach to support breastfeeding GROUP STUDY |
| No Intervention | No intervention | –ROUTINE MAINTENANCE WILL BE DONE SOLUTION-FOCUSED APPROACH WILL NOT BE APPLIED. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Over 18 years old, literate,
- Can speak Turkish,
- Primiparous and at term and healthy delivery (38-42 weeks, 2500-4000g born, 5th minute APGAR score of 7 and above, no known congenital disease),
- Women who do not have a chronic disease that prevents breastfeeding in their baby or in themselves
- Does not have a systemic disease,
Key exclusion criteria (4 listed)
- Women who do not want to breastfeed
- Women who have a disability to breastfeed
- Expressing that they cannot continue to work until the end,
- Women who did not participate and did not answer the post-test of the questionnaires.
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 |
|---|---|---|
| solution oriented approachImplementing a solution-focused approach to support breastfeeding | Behavioural | experimental group 1, experimental group 2 |
Primary outcome
Increasing mothers' "breastfeeding self-efficacy scale score"
Time frame: 12 weeks
increase in breastfeeding success of lactating puerperant women (After the solution-oriented approach application, the breastfeeding self-efficacy scale The Breastfeeding Self-Efficacy Short Form Scale is a 5-point Likert-Type scale with 1= "I am not sure at all" and 5 = "I am always sure". As Bandura (1998) suggested, all items are positive. The minimum score that can be obtained from the scale is 14, and the maximum is 70.
Increasing "Latch breastfeeding scale score"
Time frame: 12 weeks
After the solution-oriented approach application, the latch breastfeeding scale will be evaluated. Each item is evaluated between 0-2 points. The total score that can be taken from the scale is 10. The measurement tool has no cut-off point and the higher the LATCH score, the higher the success of breastfeeding.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Yes. After the research results are analyzed and published, access can be made.
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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.
özlem CAGAN, PHD principal investigator
ocagan@ogu.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing solution oriented approach in people with Postpartum and Breastfeeding, run by Eskisehir Osmangazi 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 10 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: status not confirmed, as of the sponsor's last update on 22 Feb 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?
Contact ESRA NUR KABAKCI, PHD (02222393750 ext. 1549, esranurkabakci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increasing mothers' "breastfeeding self-efficacy scale score" (time frame: 12 weeks). 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 22 Feb 2024.