NCT05543902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

1.8 years

First QC Date

September 14, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

Breastfeeding

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change in breastfeeding problems by 1st, 2nd, 6th and 8th weeks

Secondary Outcomes (1)

  • The LATCH Assessment Tool

    Change in 1th and 8th weeks breastfeeding succes level.

Other Outcomes (1)

  • The Breastfeeding Motivation Scale (BMS)

    change in breastfeeding motivation level at eight weeks

Study Arms (2)

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.

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

Interventions

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.

Intervention group: Breastfeeding Problems Management Model (BPMM)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova Unıversity

Adana, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 30829925BACKGROUND
  • 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.

    PMID: 30835887BACKGROUND
  • 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.

    PMID: 31140955BACKGROUND
  • Cercer 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Zehra ÇERÇER, PhD

    Cukurova University

    PRINCIPAL INVESTIGATOR
  • Evşen NAZİK, Prof. Dr.

    Cukurova University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 16, 2022

Study Start

June 1, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations