Clinical trial NCT05543902: The Effects of the Breastfeeding Problems Management Model on Breastfeeding Problems, Motivation and Success
Official title: The Effects of the Breastfeeding Problems Management Model (BPMM) on Breastfeeding Problems, Breastfeeding Motivation and Breastfeeding Success: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Counselling
Keywords: Breastfeeding
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. being aged between 18 and 35
2. having vaginal delivery in the 37th gestational week or later
3. being primiparous
4. having a single and healthy fetus
5. having graduated at least from a primary school
6. living in Adana city center
7. being able to communicate on the phone.

Exclusion Criteria:

1. having no high-risk pregnancy
2. having no medical diseases preventing breastfeeding
3. having no communication problems
4. having no psychiatric diseases
5. not being a health professional
6. having no health professional relatives to provide support in the postpartum care.

Criteria for being excluded from the study:

1. admission of the newborn to the intensive care
2. development of postpartum psychological problems in the mother (maternity blues, depression)
3. mother's changing city during postpartum follow-ups.

Primary outcomes:
measure: Breastfeeding Experience Scale (BES)
timeFrame: Change in breastfeeding problems by 1st, 2nd, 6th and 8th weeks
Secondary outcomes:
measure: The LATCH Assessment Tool
timeFrame: Change in 1th and 8th weeks breastfeeding succes level.
Other outcomes:
measure: The Breastfeeding Motivation Scale (BMS)
timeFrame: change in breastfeeding motivation level at eight weeks
Locations:
city: Adana
country: Turkey
facility: Cukurova Unıversity
Study officials:
affiliation: Cukurova University
name: Zehra ÇERÇER, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cukurova University
name: Evşen NAZİK, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Lucas 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.
citation: Mizrak 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.