CounsellingNCT05543902
The Effects of the Breastfeeding Problems Management Model on Breastfeeding Problems, Motivation and Success
A study testing Breastfeeding Problems Management Model (BPMM) in people with Counselling, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled interventional study was conducted with 50 women (25 intervention and 25 control). While the intervention group received an eight-week postpartum education and care according to the Breastfeeding Problems Management Model (BPMM) under the leadership of a nurse, the control group received… 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
- Counselling
- What is being tested?
- Breastfeeding Problems Management Model (BPMM)
- 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 Jun 2020to 1 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being aged between 18 and 35
- having vaginal delivery in the 37th gestational week or later
- being primiparous
- having a single and healthy fetus
- having graduated at least from a primary school
- living in Adana city center
- being able to communicate on the phone.
Who cannot join
- having no high-risk pregnancy
- having no medical diseases preventing breastfeeding
- having no communication problems
- having no psychiatric diseases
- not being a health professional
- having no health professional relatives to provide support in the postpartum care.
Show all 10Show fewer
- Criteria for being excluded from the study:
- admission of the newborn to the intensive care
- development of postpartum psychological problems in the mother (maternity blues, depression)
- mother's changing city during postpartum follow-ups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of the Breastfeeding Problems Management Model (BPMM) on Breastfeeding Problems, Breastfeeding Motivation and Breastfeeding Success: A Randomized Clinical Trial
This randomized controlled interventional study was conducted with 50 women (25 intervention and 25 control). While the intervention group received an eight-week postpartum education and care according to the Breastfeeding Problems Management Model (BPMM) under the leadership of a nurse, the control group received routine care. CONSORT checklist was used to report the study.The women in the intervention group were provided with nursing interventions according to the BPMM by the researcher. The women in standard care group were not provided with any interventions by the researcher.
Read the detailed description
This study was conducted as a randomized controlled trial to determine the effects of the Breastfeeding Problems Management Model (BPMM) on breastfeeding problems, breastfeeding motivation and breastfeeding success.
Research hypotheses H0: Mothers in the intervention and control group H01: Demonstrate no differences in terms of their "LATCH Assessment Tool" total mean scores.
H02: Demonstrate no differences in terms of their "Breastfeeding Motivation Scale" total mean scores.
H03: Demonstrate no differences in terms of their "Breastfeeding Experience Scale" total mean scores.
H1: Mothers in the intervention and control group H11: Demonstrate differences in terms of their "LATCH Assessment Tool" total mean scores.
H12: Demonstrate differences in terms of their "Breastfeeding Motivation Scale" total mean scores.
H13: Demonstrate differences in terms of their "Breastfeeding Experience Scale" total mean scores.
This study was conducted in the Obstetrics and Gynecology Clinic at Adana City Training and Research Hospital affiliated with the T.R. Ministry of Health between 01/06/2020 and 01/04/2022. The target population of the study included women who had a vaginal delivery at Adana City Training and Research Hospital affiliated with the T.R. Ministry of Health. The sample of the study was women who had vaginal delivery in the related hospital between 01/06/2020 and 01/04/2022, who met the research criteria, and who agreed to participate in the study.
Power analysis was performed after data were collected from 20 women who had a vaginal delivery (10 intervention, 10 control) for the calculation of the sample size. Power analysis conducted using values obtained from the pilot implementation via the G*Power 3.0.10, for 4 repeat models with 80% Power and 5% margin of error, indicated that at least 40 samples were adequate for 2 groups (n1:20; n2:20). Due to the probability of women's leaving the study during their follow-ups, the study included 50 women: 25 intervention and 25 control group participants.
Data were collected through the "Personal Information Form", the "Breastfeeding Experience Scale", the "LATCH Assessment Tool", and the "Breastfeeding Motivation Scale (for Primiparous Mothers)".
The study formed the "Breastfeeding Problems Management Model (BPMM)", and the nursing interventions in the intervention group were done based on this model.The BPMM was composed of interventions with the leadership of a nurse and included topics of the early postpartum period; postpartum 1st, 2nd, 6th, and 8th weeks; increasing breastfeeding motivation and breastfeeding success; and preventing and eliminating breastfeeding problems. The components of the model included meeting women face-to-face, giving education using a booklet, providing breastfeeding consultancy on the phone, and home visits.
The women in the intervention group were provided with nursing interventions according to the BPMM by the researcher. LATCH (pre-test) was administered before discharge from the hospital; women were given the education booklet; and their contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks, BES was read, and the scale was filled in by the researcher based on the women's responses. Women who were found to experience breastfeeding problems in these phone calls were provided with consultancy and home visits. In the 8th week, home visits were done and the education was repeated. The women were administered the BES, LATCH (post-test), and BMS.
The women in control group were not provided with any interventions by the researcher. They were provided with standard care at the hospital. Before discharge from the hospital, the LATCH (pre-test) was administered and women's contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks. BES were read on the phone, and the scale was filled in by the researcher based on the women's responses. Home visits were performed in the 8th week, and the women were administered the BES, LATCH (post-test), and BMS.
- Conditions
- Counselling
- Being tested
- Breastfeeding Problems Management Model (BPMM)
- Keywords
- Breastfeeding
- 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 Problems Management Model (BPMM)Behavioural
The BPMM was composed of interventions with the leadership of a nurse and included topics of the early postpartum period; postpartum 1st, 2nd, 6th, and 8th weeks; increasing breastfeeding motivation and breastfeeding success; and preventing and eliminating breastfeeding problems. The components of the model included meeting women face-to-face, giving education using a booklet, providing breastfeeding consultancy on the phone, and home visits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Breastfeeding Problems Management Model (BPMM) | Experimental | The women in the intervention group were provided with nursing interventions according to the BPMM by the researcher. LATCH (pre-test) was administered before discharge from the hospital; women were given the education booklet; and their contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks, BES was read, and the scale was filled in by the researcher based on the women's responses. Women who were found to experience breastfeeding problems in these phone calls were provided with consultancy and home visits. In the 8th week, home visits were done and the education was repeated. The women were administered the BES, LATCH (post-test), and BMS. Receives: Behavioral: Breastfeeding Problems Management Model (BPMM) |
| No Intervention: Standard care group | No intervention | The women in standard care group were not provided with any interventions by the researcher. They were provided with standard care at the hospital. Before discharge from the hospital, the LATCH (pre-test) was administered and women's contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks. BES were read on the phone, and the scale was filled in by the researcher based on the women's responses. Home visits were performed in the 8th week, and the women were administered the BES, LATCH (post-test), and BMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Experience Scale (BES)
The original scale is responded on a 5-point scale and is composed of 2 parts, 5 sub-scales, and 30 items. Turkish reliability and validity of the scale were performed by Uyanık and Çeber Turfan in 2019, and Cronbach's alpha coefficient was found 0.776. Scores to be obtained from the scale range between 18 and 90, with higher scores indicating higher severity of breastfeeding problems. BES was reported to be a valid tool for the Turkish Society.
Measured: Change in breastfeeding problems by 1st, 2nd, 6th and 8th weeks
Secondary outcomes (1)
The LATCH Assessment Tool
The LATCH Assessment Tool was developed by Jensen et al. in 1994. Reliability analysis of the tool was performed by Adams and Hewel in 1997. Turkish reliability and validity were performed by Yenal and Okumuş in 2001 and Cronbach's alpha coefficient was reported 0.95, indicating the reliability of the scale. The LATCH is composed of 5 criteria that enable a rapid and easy assessment: L: Latch on breast, A: Audible swallowing, T: Type of nipple, C: Comfortbreast/nipple, H: Hold. Each item is scored between 0 and 2, and the scores to be obtained from the scale range between 0 and 10. Higher scores indicate successful breastfeeding.
Measured: Change in 1th and 8th weeks breastfeeding succes level.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Jun 2020
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CounsellingStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra ÇERÇER, Cukurova University
- Investigators
- Zehra ÇERÇER, PhD, Principal investigator, Cukurova UniversityEvşen NAZİK, Prof. Dr., Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543902
- Sponsor's protocol ID
- 2020-25
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucas R, Zhang Y, Walsh SJ, Evans H, Young E, Starkweather A. Efficacy of a Breastfeeding Pain Self-Management Intervention: A Pilot Randomized Controlled Trial. Nurs Res. 2019 Mar/Apr;68(2):E1-E10. doi: 10.1097/NNR.0000000000000336.
PubMed 30829925Lucas R, Bernier K, Perry M, Evans H, Ramesh D, Young E, Walsh S, Starkweather A. Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial. Res Nurs Health. 2019 Jun;42(3):176-188. doi: 10.1002/nur.21938. Epub 2019 Mar 5.
PubMed 30835887Mizrak Sahin B, Ozerdogan N, Ozdamar K, Gursoy E. Factors affecting breastfeeding motivation in primiparious mothers: An application of breastfeeding motivation scale based on self-determination theory. Health Care Women Int. 2019 Jun;40(6):637-652. doi: 10.1080/07399332.2018.1526289. Epub 2019 May 29.
PubMed 31140955Cercer Z, Nazik E Dr. The effects of the breastfeeding problems management model on breastfeeding problems, breastfeeding motivation and breastfeeding success: A randomized controlled trial. J Pediatr Nurs. 2023 Nov-Dec;73:e116-e124. doi: 10.1016/j.pedn.2023.07.021. Epub 2023 Aug 6.
PubMed 37550129
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Breastfeeding Problems Management Model (BPMM) on Breastfeeding Problems, Breastfeeding Motivation and Breastfeeding Success: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05543902
- Acronym / sponsor ID
- 2020-25
- Conditions
- Counselling
- Keywords
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 16 Sep 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.
This randomized controlled interventional study was conducted with 50 women (25 intervention and 25 control). While the intervention group received an eight-week postpartum education and care according to the Breastfeeding Problems Management Model (BPMM) under the leadership of a nurse, the control group received routine care. CONSORT checklist was used to report the study.The women in the intervention group were provided with nursing interventions according to the BPMM by the researcher. The women in standard care group were not provided with any interventions by the researcher.
Detailed description
This study was conducted as a randomized controlled trial to determine the effects of the Breastfeeding Problems Management Model (BPMM) on breastfeeding problems, breastfeeding motivation and breastfeeding success.
Research hypotheses H0: Mothers in the intervention and control group H01: Demonstrate no differences in terms of their "LATCH Assessment Tool" total mean scores.
H02: Demonstrate no differences in terms of their "Breastfeeding Motivation Scale" total mean scores.
H03: Demonstrate no differences in terms of their "Breastfeeding Experience Scale" total mean scores.
H1: Mothers in the intervention and control group H11: Demonstrate differences in terms of their "LATCH Assessment Tool" total mean scores.
H12: Demonstrate differences in terms of their "Breastfeeding Motivation Scale" total mean scores.
H13: Demonstrate differences in terms of their "Breastfeeding Experience Scale" total mean scores.
This study was conducted in the Obstetrics and Gynecology Clinic at Adana City Training and Research Hospital affiliated with the T.R. Ministry of Health between 01/06/2020 and 01/04/2022. The target population of the study included women who had a vaginal delivery at Adana City Training and Research Hospital affiliated with the T.R. Ministry of Health. The sample of the study was women who had vaginal delivery in the related hospital between 01/06/2020 and 01/04/2022, who met the research criteria, and who agreed to participate in the study.
Power analysis was performed after data were collected from 20 women who had a vaginal delivery (10 intervention, 10 control) for the calculation of the sample size. Power analysis conducted using values obtained from the pilot implementation via the G*Power 3.0.10, for 4 repeat models with 80% Power and 5% margin of error, indicated that at least 40 samples were adequate for 2 groups (n1:20; n2:20). Due to the probability of women's leaving the study during their follow-ups, the study included 50 women: 25 intervention and 25 control group participants.
Data were collected through the "Personal Information Form", the "Breastfeeding Experience Scale", the "LATCH Assessment Tool", and the "Breastfeeding Motivation Scale (for Primiparous Mothers)".
The study formed the "Breastfeeding Problems Management Model (BPMM)", and the nursing interventions in the intervention group were done based on this model.The BPMM was composed of interventions with the leadership of a nurse and included topics of the early postpartum period; postpartum 1st, 2nd, 6th, and 8th weeks; increasing breastfeeding motivation and breastfeeding success; and preventing and eliminating breastfeeding problems. The components of the model included meeting women face-to-face, giving education using a booklet, providing breastfeeding consultancy on the phone, and home visits.
The women in the intervention group were provided with nursing interventions according to the BPMM by the researcher. LATCH (pre-test) was administered before discharge from the hospital; women were given the education booklet; and their contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks, BES was read, and the scale was filled in by the researcher based on the women's responses. Women who were found to experience breastfeeding problems in these phone calls were provided with consultancy and home visits. In the 8th week, home visits were done and the education was repeated. The women were administered the BES, LATCH (post-test), and BMS.
The women in control group were not provided with any interventions by the researcher. They were provided with standard care at the hospital. Before discharge from the hospital, the LATCH (pre-test) was administered and women's contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks. BES were read on the phone, and the scale was filled in by the researcher based on the women's responses. Home visits were performed in the 8th week, and the women were administered the BES, LATCH (post-test), and BMS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Breastfeeding Problems Management Model (BPMM) | Experimental | Behavioral: Breastfeeding Problems Management Model (BPMM)The women in the intervention group were provided with nursing interventions according to the BPMM by the researcher. LATCH (pre-test) was administered before discharge from the hospital; women were given the education booklet; and their contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks, BES was read, and the scale was filled in by the researcher based on the women's responses. Women who were found to experience breastfeeding problems in these phone calls were provided with consultancy and home visits. In the 8th week, home visits were done and the education was repeated. The women were administered the BES, LATCH (post-test), and BMS. |
| No Intervention: Standard care group | No intervention | –The women in standard care group were not provided with any interventions by the researcher. They were provided with standard care at the hospital. Before discharge from the hospital, the LATCH (pre-test) was administered and women's contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks. BES were read on the phone, and the scale was filled in by the researcher based on the women's responses. Home visits were performed in the 8th week, and the women were administered the BES, LATCH (post-test), and BMS |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- being aged between 18 and 35
- having vaginal delivery in the 37th gestational week or later
- being primiparous
- having a single and healthy fetus
- having graduated at least from a primary school
Key exclusion criteria (10 listed)
- having no high-risk pregnancy
- having no medical diseases preventing breastfeeding
- having no communication problems
- having no psychiatric diseases
- not being a health professional
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 Problems Management Model (BPMM)The BPMM was composed of interventions with the leadership of a nurse and included topics of the early postpartum period; postpartum 1st, 2nd, 6th, and 8th weeks; increasing breastfeeding motivation and breastfeeding success; and preventing and eliminating breastfeeding problems. The components of the model included meeting women face-to-face, giving education using a booklet, providing breastfeeding consultancy on the phone, and home visits. | Behavioural | Intervention group: Breastfeeding Problems Management Model (BPMM) |
Primary outcome
Breastfeeding Experience Scale (BES)
Time frame: Change in breastfeeding problems by 1st, 2nd, 6th and 8th weeks
The original scale is responded on a 5-point scale and is composed of 2 parts, 5 sub-scales, and 30 items. Turkish reliability and validity of the scale were performed by Uyanık and Çeber Turfan in 2019, and Cronbach's alpha coefficient was found 0.776. Scores to be obtained from the scale range between 18 and 90, with higher scores indicating higher severity of breastfeeding problems. BES was reported to be a valid tool for the Turkish Society.
1 secondary outcome
The LATCH Assessment Tool
Time frame: Change in 1th and 8th weeks breastfeeding succes level.
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 Sep 2022.
- Background: PubMed 30829925Lucas R, Zhang Y, Walsh SJ, Evans H, Young E, Starkweather A. Efficacy of a Breastfeeding Pain Self-Management Intervention: A Pilot Randomized Controlled Trial. Nurs Res. 2019 Mar/Apr;68(2):E1-E10. doi: 10.1097/NNR.0000000000000336.
- Background: PubMed 30835887Lucas R, Bernier K, Perry M, Evans H, Ramesh D, Young E, Walsh S, Starkweather A. Promoting self-management of breast and nipple pain in breastfeeding women: Protocol of a pilot randomized controlled trial. Res Nurs Health. 2019 Jun;42(3):176-188. doi: 10.1002/nur.21938. Epub 2019 Mar 5.
- Background: PubMed 31140955Mizrak Sahin B, Ozerdogan N, Ozdamar K, Gursoy E. Factors affecting breastfeeding motivation in primiparious mothers: An application of breastfeeding motivation scale based on self-determination theory. Health Care Women Int. 2019 Jun;40(6):637-652. doi: 10.1080/07399332.2018.1526289. Epub 2019 May 29.
- Derived from this study: PubMed 37550129Cercer Z, Nazik E Dr. The effects of the breastfeeding problems management model on breastfeeding problems, breastfeeding motivation and breastfeeding success: A randomized controlled trial. J Pediatr Nurs. 2023 Nov-Dec;73:e116-e124. doi: 10.1016/j.pedn.2023.07.021. Epub 2023 Aug 6.
- Individual participant dataSharing planned: No
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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.
Zehra ÇERÇER, PhD principal investigator
Cukurova University
Evşen NAZİK, Prof. Dr. study director
Cukurova University
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 Problems Management Model (BPMM) in people with Counselling, run by Cukurova 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 7 inclusion and 10 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 Sep 2022. 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 Experience Scale (BES) (time frame: Change in breastfeeding problems by 1st, 2nd, 6th and 8th weeks). 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 NCT05543902, which also lists 4 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 16 Sep 2022.