Investigating the Effect of Breastfeeding Support on Mothers Breastfeeding Comfort

NCT06650254 | Completed DMC

• 1 other identifier: Özge KAYA
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The World Health Organization and the United Nations Children\'s Fund report that exclusive breastfeeding for six months and continuing breastfeeding for two years or longer with appropriate complementary foods is one of the most powerful practices to increase the survival and well-being of the child. Some difficulties experienced during the breastfeeding process negatively affect the continuation of breastfeeding and prevent the baby from receiving breast milk. It has been determined in the studies in the literature that various interventions have been made and recommendations have been made to increase breastfeeding rates. However, it has been seen that there is a need for studies that address the needs of mothers regarding breastfeeding problems in a holistic manner and provide support in line with their needs. In order to increase breastfeeding success and ensure the continuity of effective breastfeeding, it is obvious that a holistic assessment of mothers; breastfeeding problems is needed, physical, psychospiritual, sociocultural and environmental factors that may cause deterioration in comfort are determined and comfort-focused nursing support is provided. In this context, the aim of the study is to determine the effect of the breastfeeding support structured according to Kolcaba\'s comfort theory given to mothers in the postpartum period on the breastfeeding comfort of mothers, and the second aim is to develop the \"Postpartum Breastfeeding Comfort Scale\" and test its validity and reliability. Hypotheses of the study: H0: The breastfeeding support structured according to Kolcaba\'s comfort theory given to mothers in the postpartum period is not an effective method in increasing the breastfeeding comfort of mothers. H1: The breastfeeding support structured according to Kolcaba\'s comfort theory given to mothers in the postpartum period increases the breastfeeding comfort of mothers. H2: "Postpartum Breastfeeding Comfort Scale" is a valid and reliable tool for measuring mothers\' breastfeeding comfort.

Conditions

Breastfeeding Support

Keywords

Kolcaba's Comfort Theory; Breastfeeding; Breastfeeding Support; Breastfeeding Comfort

Outcome Measures

Primary Outcomes (2)

• Evaluation of breastfeeding comfort in the study and control groups

  The Postpartum Breastfeeding Comfort Scale, which will be developed within the scope of the study, has a total of 49 items in the scale focusing on mothers\' breastfeeding comfort. The scale is a 5-point Likert type and each item is scored between 1 and 5. A high score obtained from the scale indicates a high breastfeeding comfort level.

  Pre-test on postpartum day 0

• Evaluation of breastfeeding comfort in the study and control groups

  The Postpartum Breastfeeding Comfort Scale, which will be developed within the scope of the study, has a total of 49 items in the scale focusing on mothers\' breastfeeding comfort. The scale is a 5-point Likert type and each item is scored between 1 and 5. A high score obtained from the scale indicates a high breastfeeding comfort level.

  Post-test at 6-8 weeks postpartum

Study Arms (2)

Control Group

NO INTERVENTION

The mothers in the control group will be followed in line with the hospital's routine health monitoring and information.

Breastfeeding Support Program Structured According to Kolcaba's Comfort Theory

EXPERIMENTAL

Mothers who are on postpartum day 0 will be included in the "Breastfeeding Support Program Structured According to Kolcaba's Comfort Theory" in addition to the routine follow-up and training they can receive from the hospital.

Other: Breastfeeding Support Program Structured According to Kolcaba's Comfort Theory

Interventions

Breastfeeding Support Program Structured According to Kolcaba's Comfort Theory OTHER

Stage 1: The "Postpartum Breastfeeding Comfort Scale" will be applied to mothers before they are admitted to the support program. On the 0th day postpartum, the researcher will go to the mother, baby and father and provide "mother-baby skin-to-skin contact and breastfeeding support (Module 1)". Stage 2: The videos aimed at increasing breastfeeding comfort, which were shot for Modules 2, 3, 4 and 5 and transferred to the website, will be watched by mothers and fathers/relatives after discharge. At the same time, online counseling will be provided through the website and support will be provided for applications that will increase breastfeeding comfort. Stage 3: Mothers who have participated in at least 70% of the breastfeeding support structured according to Kolcaba's Comfort Theory will be called after 6-8 weeks and the "Postpartum Breastfeeding Comfort Scale" will be applied again and their final tests will be performed.

Breastfeeding Support Program Structured According to Kolcaba's Comfort Theory

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breastfeeding mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a nuclear family structure,
• Living in the same house with their spouse,
• Having a medium socioeconomic level,
• The mother and baby are healthy,
• Not having sensory losses such as vision or hearing,
• Not having a diagnosed psychiatric history,
• Being able to read and write Turkish,
• Being open to communication and cooperation,
• Being a volunteer to participate in the research.

You may not qualify if:

• Annelerin postpartum süreçte travmatik bir durum yaşaması (bu durumdaki annelerle çalışma devam edecek ancak anneler analize alınmayacak),
• Kolcaba'nın Konfor Kuramına göre yapılandırılmış emzirme desteğine %70 katılmamış olmak

Sponsors & Collaborators

• Ozge Kaya: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Sakarya University

Sakarya, Serdivan, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind (researchers are not blinded) randomization is recorded as the mothers will be supported by the researchers face to face and via the Web application. The statistician is also blinded for data analysis purposes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: October 21, 2024
• Study Start: May 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)